96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215

  
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT03747718
(ClinicalTrials.gov)
December 1, 20228/3/2018Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in ChildrenA Study for Evaluation of Clinical Response to Single vs. Maintenance Fecal Microbiota Transplantation in Pediatric Patients With Refractory Crohn's DiseaseCrohn DiseaseBiological: Fecal Microbiota Transplantation;Other: PlaceboStanford UniversityNULLNot yet recruiting2 Years25 YearsAll30Phase 1United States
2NCT04991324
(ClinicalTrials.gov)
September 202227/7/2021Cholecalciferol Comedication in IBD - the 5C StudyCholecalciferol Comedication in Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C StudyInflammatory Bowel DiseasesDrug: Vitamin D3University Hospital, Basel, SwitzerlandNULLNot yet recruiting18 YearsN/AAll150Phase 3NULL
3NCT05242471
(ClinicalTrials.gov)
May 20, 202215/2/2022A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 2b Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseBiological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804Janssen Research & Development, LLCNULLNot yet recruiting18 Years65 YearsAll650Phase 2Italy
4NCT05248191
(ClinicalTrials.gov)
April 1, 20229/2/2022FMT for Postop Crohn's DiseaseFecal Microbiota Transplant for Postoperative Crohn's DiseaseCrohn DiseaseBiological: Capsule fecal microbiota material (cap-FMT);Biological: Colonoscopic fecal microbiota material (colo-FMT)University of MinnesotaNULLNot yet recruiting18 YearsN/AAll30Phase 1United States
5NCT05284136
(ClinicalTrials.gov)
April 1, 202228/2/2022Exclusion Diet vs corticosteroIds in patientS With activE Crohn's DiseaseProspective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISECrohn DiseaseDietary Supplement: Crohn's disease exclusion diet (CDED);Drug: Oral prednisoloneAssistance Publique - Hôpitaux de ParisNULLNot yet recruiting16 Years70 YearsAll80Phase 2/Phase 3France;Netherlands
6NCT05043870
(ClinicalTrials.gov)
April 1, 20222/9/2021Combined Immunosuppression for Pediatric Crohn's DiseaseCombination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's DiseaseCrohn Disease;Infliximab;Immunosuppression;Children, OnlyDrug: Infliximab and immunosuppressives;Drug: InfliximabChildren's Hospital of Fudan UniversityNULLNot yet recruiting2 Years18 YearsAll40Phase 4NULL
7NCT04966585
(ClinicalTrials.gov)
March 15, 20228/7/2021Pilot Study of Posaconazole in Crohn's DiseaseA Multicenter Randomized, Double-Blinded, Placebo-Controlled Study of Posaconazole in Genetically-Defined Patients With Active Crohn's DiseaseCrohn Disease;CARD9 S12N Risk AlleleDrug: Posaconazole Delayed Release Oral Tablet;Drug: Matching Placebo TabletCedars-Sinai Medical CenterNULLNot yet recruiting18 Years60 YearsAll24Phase 4United States
8EUCTR2021-002869-18-BE
(EUCTR)
14/03/202225/10/2021This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 Subjects with moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABBV-154
Product Code: ABBV-154
INN or Proposed INN: ABBV-154
Product Name: ABBV-154
Product Code: ABBV-154
INN or Proposed INN: ABBV-154
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
265Phase 2United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
9EUCTR2019-002687-27-HR
(EUCTR)
10/03/202214/03/2022A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
10NCT05242458
(ClinicalTrials.gov)
March 2, 202215/2/2022A Study of Ustekinumab Treatment in Children With Crohn's DiseaseReal-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children With Crohn's Disease: A Retrospective Cohort Study Using the ImproveCareNow Registry DataCrohn's DiseaseDrug: UstekinumabJanssen Research & Development, LLCImproveCareNow (ICN);Children's Hospital Medical Center, CincinnatiNot yet recruiting2 Years25 YearsAll662United States
11NCT04456517
(ClinicalTrials.gov)
March 1, 202229/6/2020Reduce Crohn's-Associated Diarrhea With Sodium Channel TherapyREACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated DiarrheaCrohn's Disease;Inflammatory Bowel DiseaseDrug: Ranolazine;Drug: PlaceboVanderbilt University Medical CenterNULLEnrolling by invitation18 YearsN/AAll16Phase 2United States
12NCT05130983
(ClinicalTrials.gov)
March 1, 202216/11/2021A Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Crohn's DiseaseA Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Crohn's DiseaseCrohn Disease;IBD - Irritable Bowel DiseaseDrug: Bone Marrow MSC Derived Extracellular Vesicle IsolateDirect Biologics, LLCNULLNot yet recruiting18 Years75 YearsAll10Phase 1NULL
13NCT05239702
(ClinicalTrials.gov)
February 28, 20221/12/2021Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune DiseasesA Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune DiseasesCrohn Disease;Ulcerative Colitis;Dermatomyositis;Still Disease;Autoimmune DiseasesBiological: CD7 CAR T-cellsZhejiang UniversityYake Biotechnology Ltd.RecruitingN/AN/AAll75Early Phase 1China
14NCT04779320
(ClinicalTrials.gov)
February 28, 20221/3/2021A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous TherapyCrohn's Disease (CD)Drug: Vedolizumab IVTakedaNULLNot yet recruiting2 Years17 YearsAll120Phase 3NULL
15NCT05262829
(ClinicalTrials.gov)
February 28, 20228/2/2022Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate and Severe Crohn's DiseaseA Single-arm, Open-label Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Moderate to Severe Crohn's DiseaseCrohn DiseaseBiological: Human Umbilical Cord Mesenchymal Stem CellsShanghai East HospitalNULLNot yet recruiting18 Years70 YearsAll40N/AChina
16EUCTR2021-002869-18-GR
(EUCTR)
18/02/202216/11/2021This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 Subjects with moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABBV-154
Product Code: ABBV-154
INN or Proposed INN: ABBV-154
Product Name: ABBV-154
Product Code: ABBV-154
INN or Proposed INN: ABBV-154
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
265Phase 2United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
17EUCTR2021-002869-18-CZ
(EUCTR)
10/02/202230/11/2021This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 Subjects with moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABBV-154
Product Code: ABBV-154
INN or Proposed INN: ABBV-154
Product Name: ABBV-154
Product Code: ABBV-154
INN or Proposed INN: ABBV-154
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
265Phase 2United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
18NCT04777656
(ClinicalTrials.gov)
February 202226/2/2021Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone.Crohn's DiseaseDietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy;Dietary Supplement: Phase2 and 3 :Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin;MICALIS InstituteNot yet recruiting6 Years17 YearsAll120Phase 3France
19NCT05068284
(ClinicalTrials.gov)
January 31, 202227/9/2021A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's DiseaseA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CDCrohn's DiseaseDrug: ABBV-154;Drug: PlaceboAbbVieNULLRecruiting18 Years75 YearsAll265Phase 2United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom
20EUCTR2021-002869-18-ES
(EUCTR)
20/01/202215/09/2021This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 Subjects with moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ABBV-154
Product Code: ABBV-154
INN or Proposed INN: ABBV-154
Product Name: ABBV-154
Product Code: ABBV-154
INN or Proposed INN: ABBV-154
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
265Phase 2United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
21EUCTR2020-005770-99-NO
(EUCTR)
20/01/202223/09/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease Fibrostenotic Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: SPESOLIMAB
Boehringer Ingelheim Norway KSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden
22NCT05197049
(ClinicalTrials.gov)
January 17, 202217/1/2022A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's DiseaseA Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll318Phase 3United States;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;China;Croatia;Czechia;France;Germany;Hungary;Italy;Japan;Jordan;Korea, Republic of;Lithuania;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom
23JPRN-jRCT2071210031
15/01/202201/06/2021A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's DiseaseA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy Crohn's DiseaseInduction Period: Participants >=30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of >=30 kg will be included in this arm group

Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group.

Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this armgroup.

Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.

Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.

Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.

Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q
Shikamura MitsuhiroNULLPending>= 2age old<= 17age oldBoth120Phase 3United States;Australia;Belgium;Bosnia;Croatia;Czech Republic;Hungary;Germany;Italy;Israel;Lithuania;New Zealand;Poland;Romania;Slovakia;Russia;Ukraine;Spain;United Kingdom;China;Japan
24NCT04804540
(ClinicalTrials.gov)
January 10, 202215/3/2021A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's DiseaseA Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn DiseaseDrug: Vedolizumab IVTakedaNULLNot yet recruiting18 Years65 YearsAll150Phase 4NULL
25NCT04530877
(ClinicalTrials.gov)
January 1, 202224/8/2020Exclusive Enteral Nutrition vs. Infliximab in Chinese CD PatientsComparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's DiseaseCrohn's Disease;Exclusive Enteral Nutrition;Infliximab;Mucosal HealingBiological: Infliximab;Dietary Supplement: Exclusive Enteral NutritionChildren's Hospital of Fudan UniversityNULLNot yet recruiting1 Year18 YearsAll80Phase 4NULL
26NCT05075811
(ClinicalTrials.gov)
January 1, 202228/9/2021Study of Ossium Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in the Setting of Crohn's DiseaseA Phase IB/IIA Study of Ossium Vertebral Bone Marrow Derived Mesenchymal Stem Cells (vBM-MSC) for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the PouchPouch, Ileal;FistulaDrug: Ossium vBM-MSC;Other: PlaceboAmy LightnerOssium Health, Inc.Not yet recruiting18 Years75 YearsAll20Phase 1/Phase 2United States
27NCT05039411
(ClinicalTrials.gov)
January 1, 20221/9/2021Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's DiseaseA Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's DiseasePerianal Fistula Due to Crohn's Disease;Fistula in AnoBiological: Human umbilical cord mesenchymal stem cells (UC-MSCs)CryoCord Sdn BhdUniversity of MalayaNot yet recruiting18 YearsN/AAll7Phase 1Malaysia
28NCT05049525
(ClinicalTrials.gov)
January 202225/8/2021Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's DiseaseEvaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease Not Responding Adequately to Current TherapyCrohn's Disease;Inflammatory Bowel DiseasesDrug: Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.;Drug: Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally.Montreal Heart InstituteNULLNot yet recruiting18 Years65 YearsAll68Phase 2NULL
29NCT04779762
(ClinicalTrials.gov)
January 202228/2/2021Stelara and Diet Trial for Crohns DiseaseStelara and CDED Diet Trial for Crohns DiseaseCrohn DiseaseOther: Crohn's disease exclusion diet (CDED);Drug: Ustekinumab Injection [Stelara]Wolfson Medical CenterSheba Medical Center, IsraelNot yet recruiting18 Years65 YearsAll40N/AIsrael
30NCT04924270
(ClinicalTrials.gov)
January 20227/6/2021Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory DiseasesSafety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory TrialRheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative ColitisBiological: Faecal microbiota transplantation;Other: PlaceboTorkell EllingsenRegion of Southern Denmark;University of Southern DenmarkNot yet recruiting18 Years70 YearsAll200Phase 2NULL
31EUCTR2019-001866-14-IT
(EUCTR)
21/12/202112/10/2021Open-label Extension Study of Brazikumab in Crohn's DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE) - INTREPID OLE Moderately to Severely Active Crohn's Disease.
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: [MEDI2070]
INN or Proposed INN: ( L ) ASCORBATO DI CALCIO
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
Product Name: Brazikumab
Product Code: [MEDI2070]
INN or Proposed INN: ( L ) ASCORBATO DI CALCIO
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
ASTRAZENECA ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of
32EUCTR2020-004527-16-IT
(EUCTR)
21/12/202129/09/2021A study to test whether BI 706321 combined with ustekinumab helps people with Crohn’s DiseaseA Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment - InCharge Crohn`s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Stelara 130mg / 26mL concentrate for solution for infusion
Product Name: Stelara 130mg / 26mL concentrate for solution for infusion
Product Code: [Stelara 130mg / 26mL concentrate for solution for
INN or Proposed INN: USTEKINUMAB
Product Name: BI 706321
Product Code: [BI 706321]
Product Name: BI 706321
Product Code: [BI 706321]
Product Name: BI 706321
Product Code: [BI 706321]
Trade Name: STELARA - 90 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) 1 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 1 ML
Product Name: Stelara 90mg/1ml solution for injection in pre-filled syringe (PFS)
Product Code: [Stelara 90mg/1ml solution for injecti
BOEHRINGER INGELHEIM INTERNATIONAL GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2France;United States;Czechia;Spain;Poland;Belgium;Italy
33NCT05029921
(ClinicalTrials.gov)
December 10, 202130/8/2021A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's DiseaseA Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: UstekinumabJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll180Phase 4China
34EUCTR2020-004775-40-HR
(EUCTR)
07/12/202116/12/2021A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan
35NCT04186247
(ClinicalTrials.gov)
December 20212/12/2019Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)Personalized AZithromycin/metronidAZole, in Combination With Standard Induction Therapy, to Achieve a Fecal Microbiome Community Structure and Metagenome Changes Associated With Sustained Remission in Pediatric Crohn's Disease (CD): a Pilot StudyCrohn Disease;Pediatric Crohns DiseaseDrug: Azithromycin;Drug: Metronidazole;Other: Standard of CareUniversity of North Carolina, Chapel HillCrohn's and Colitis Foundation;University of AmsterdamNot yet recruiting3 Years17 YearsAll20Phase 2United States;Canada;Israel;Netherlands
36NCT05113095
(ClinicalTrials.gov)
November 30, 20215/11/2021A Survey of Darvadstrocel in People With Crohn's DiseasePostmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocel for the Treatment of Complex Perianal Fistulas in Crohn's Disease Patients (J-INSPIRE) (All-case Surveillance)Crohn's DiseaseBiological: DarvadstrocelTakedaNULLRecruiting20 YearsN/AAll275Japan
37EUCTR2019-000824-17-SK
(EUCTR)
25/11/202129/07/2021A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease Patients with Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: BT-11
Other descriptive name: BT-11
Landos Biopharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Turkey;North Macedonia;Poland;Croatia;Albania;Georgia;Bulgaria;Bosnia and Herzegovina
38EUCTR2020-005770-99-IT
(EUCTR)
24/11/202128/09/2021A study to test whether spesolimab helps people with Crohn's disease whohave symptoms of bowel obstructionMulti-center, double-blind, randomized, placebo-controlled, phase IIa trialto evaluate spesolimab (BI 655130) efficacy in patients with fibrostenoticCrohn's Disease - - Fibrostenotic Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BI 655130
Product Code: [BI 655130]
INN or Proposed INN: SPESOLIMAB
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Aruba;Australia;Denmark;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden
39EUCTR2021-000092-37-PL
(EUCTR)
19/11/202117/08/2021A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;France;Czech Republic;Canada;Poland;Belgium;Australia;Georgia
40EUCTR2020-001811-26-BE
(EUCTR)
18/11/202122/07/2021IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 4Belgium;Netherlands
41NCT05078879
(ClinicalTrials.gov)
November 16, 202114/10/2021Empagliflozin as a Treatment for Severe Congenital Neutropenia Due to G6PC3 DeficiencyA Phase 1 Study of Empagliflozin as Treatment for Severe Congenital Neutropenia Due to G6PC3 DeficiencyCrohn's Disease;Glycogen Metabolism;Inflammatory Bowel Disease (IBD)Drug: EmpagliflozinNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting18 YearsN/AAll10Phase 1United States
42EUCTR2020-005770-99-NL
(EUCTR)
12/11/202105/08/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease Fibrostenotic Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: SPESOLIMAB
Boehringer IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Serbia;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden
43EUCTR2020-004775-40-DK
(EUCTR)
11/11/202104/06/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
44NCT05013385
(ClinicalTrials.gov)
November 9, 202113/8/2021A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel ObstructionMulti-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's DiseaseFibrostenotic Crohn´s DiseaseDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLRecruiting18 Years75 YearsAll100Phase 2Austria;Belgium;Canada;Germany;Korea, Republic of;Netherlands;Norway;Sweden
45EUCTR2020-005770-99-IE
(EUCTR)
09/11/202130/07/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease Fibrostenotic Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: SPESOLIMAB
Boehringer Ingelheim LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Serbia;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden
46EUCTR2019-001866-14-HU
(EUCTR)
09/11/202102/08/2021Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of
47EUCTR2021-000092-37-CZ
(EUCTR)
03/11/202107/06/2021A study of PRA023 in patients with Crohn's DiseaseA Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PRA023
INN or Proposed INN: Not yet assigned
Other descriptive name: PRA023
Prometheus Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2United States;France;Czechia;Czech Republic;Canada;Poland;Belgium;Ukraine;Australia;Russian Federation;Georgia
48NCT04835506
(ClinicalTrials.gov)
November 1, 20215/4/2021Proactive IFX Optimization vs SOC in Patients With CDProactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Crohn's Disease: The OPTIMIZE TrialCrohn DiseaseDrug: InfliximabBeth Israel Deaconess Medical CenterThe Leona M. and Harry B. Helmsley Charitable Trust;Icahn School of Medicine at Mount SinaiRecruiting16 YearsN/AAll196Phase 4United States
49NCT04629196
(ClinicalTrials.gov)
November 202110/11/2020Induction Optimization With Stelara for Crohn's DiseaseInduction Optimization With Stelara for Crohn's DiseaseCrohn DiseaseDrug: UstekinumabNYU Langone HealthNULLNot yet recruiting18 Years70 YearsAll113Phase 4United States
50NCT05057273
(ClinicalTrials.gov)
November 202116/8/2021Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe DiseaseA Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe DiseaseCrohn's DiseaseDrug: BT-11 (Omilancor);Biological: adalimumabLandos Biopharma Inc.NULLNot yet recruiting18 Years75 YearsAll40Phase 2NULL
51NCT05088369
(ClinicalTrials.gov)
November 202112/10/2021Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults)Ulcerative Colitis;Crohn's DiseaseDrug: HM201;Drug: PlaceboSyneos HealthHimuka AM Pharma Corp.Not yet recruiting18 Years55 YearsAll68Early Phase 1NULL
52NCT04626947
(ClinicalTrials.gov)
October 30, 202129/9/2020Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease;C. Diff. InfectionsBiological: BezlotoxumabDavid Binion, MDMerck Sharp & Dohme Corp.Recruiting18 YearsN/AAll50Phase 4United States
53EUCTR2020-004457-76-PL
(EUCTR)
28/10/202115/09/2021A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions.A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3France;United States;Argentina;Poland;Turkey;Russian Federation;Japan
54NCT05028946
(ClinicalTrials.gov)
October 28, 202124/8/2021A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's DiseaseA Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: ForalumabTiziana Life Sciences, PLCNULLNot yet recruiting18 Years70 YearsAll16Phase 1NULL
55EUCTR2019-001866-14-ES
(EUCTR)
27/10/202130/09/2020Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Allergan LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3China;Korea, Republic of;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany
56EUCTR2020-005770-99-SE
(EUCTR)
20/10/202102/09/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease Fibrostenotic Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: SPESOLIMAB
Boehringer Ingelheim ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden
57NCT05092269
(ClinicalTrials.gov)
October 18, 202113/10/2021A Long-term Extension Study of Ustekinumab in Pediatric ParticipantsA Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)Crohn Disease;Colitis, Ulcerative;Arthritis, PsoriaticDrug: UstekinumabJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll151Phase 3United States;Belgium;France;Hungary;Poland
58NCT05072782
(ClinicalTrials.gov)
October 15, 202118/8/2021Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)Crohn DiseaseDrug: Infliximab CT-P13;Drug: Immunosuppressors (Thiopurines or Methotrexate)Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesCelltrionNot yet recruiting18 Years65 YearsAll360Phase 4NULL
59EUCTR2020-004775-40-HU
(EUCTR)
15/10/202109/06/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland
60EUCTR2018-004346-42-HU
(EUCTR)
15/10/202131/01/2020A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
553Phase 2;Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of
61EUCTR2020-004301-31-IT
(EUCTR)
13/10/202130/08/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's diseaseA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - - Moderately to severely active Crohn's disease (CD)
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO
Product Name: Vedolizumab
Product Code: [NA]
INN or Proposed INN: Vedolizumab
Other descriptive name: MLN0002
TAKEDA DEVELOPMENT CENTER AMERICAS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
62EUCTR2021-000469-33-NL
(EUCTR)
12/10/202125/03/2021Scientific medical research comparing the effectiveness of Infliximab by injection in the abdominal tissiue (subcutaneous) monotherapy and infliximab subcutaneous injection with anti-inflammatory drugs in the treatment of moderate to severe chronic inflammatory bowel disease.A Prospective Multicenter Randomized Controlled, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn’s Disease. - DIRECT CD Crohns disease;Therapeutic area: Body processes [G] - Biological Phenomena [G16]Trade Name: Remsima
Product Name: Remsima
Product Code: EMEA/H/C/002576
Trade Name: Puri Nethol
Product Name: Puri Nethol
Product Code: RVG00859
Trade Name: Imuran
Product Name: Imuran
Trade Name: Thiosix
Product Name: Thiosix
Product Code: RVG 114681
Trade Name: Ebetrex 15 mg = 0,75 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml
Product Name: Ebetrex
Product Code: RVG 116648
Amsterdam UMC location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
158Phase 3;Phase 4Netherlands
63NCT04913467
(ClinicalTrials.gov)
October 8, 20213/5/2021Effect of Ileocolonic Delivered Vitamins and an Anti-Inflammatory Diet on Crohn's Disease and Healthy VolunteersPotential Effects of Ileocolonic Delivered Vitamins or the Groningen Anti-Inflammatory Diet on Course of Crohn's Disease and the Microbiome of Healthy Volunteers: a Randomized Controlled Trial - The Vita-GrAID StudyCrohn DiseaseOther: Groningen Anti-Inflammatory Diet (GrAID);Dietary Supplement: ColoVit capsule;Other: ColoPulse-placebo capsuleUniversity Medical Center GroningenNULLRecruiting18 Years80 YearsAll510N/ANetherlands
64NCT04978493
(ClinicalTrials.gov)
October 4, 202126/7/2021A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's DiseaseA Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction TreatmentCrohn DiseaseDrug: BI 706321;Drug: ustekinumab;Drug: PlaceboBoehringer IngelheimNULLRecruiting18 Years75 YearsAll50Phase 2United States;Poland
65NCT03712826
(ClinicalTrials.gov)
October 202116/8/2018Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's DiseaseIdentification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's DiseaseCrohn DiseaseDrug: Anti-TNF Drug;Drug: UstekinumabHospices Civils de LyonNULLNot yet recruiting18 YearsN/AAll60N/AFrance
66EUCTR2020-004775-40-BG
(EUCTR)
29/09/202113/07/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Poland;Bulgaria;Georgia;Germany;Norway;Japan;Belgium;Belarus;Portugal;Philippines;Slovakia;Greece;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina
67EUCTR2020-004775-40-ES
(EUCTR)
27/09/202128/09/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
68EUCTR2019-001866-14-PL
(EUCTR)
27/09/202108/09/2021Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of
69EUCTR2020-004775-40-PT
(EUCTR)
24/09/202111/06/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Portugal;Belarus;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
70EUCTR2020-005770-99-DK
(EUCTR)
22/09/202120/08/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease Fibrostenotic Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: SPESOLIMAB
Boehringer Ingelheim B.VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden
71NCT04997733
(ClinicalTrials.gov)
September 22, 20215/7/2021Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF WithdrawalFecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF WithdrawalCrohn DiseaseDrug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation (placebo)Assistance Publique - Hôpitaux de ParisCRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, FranceRecruiting18 Years74 YearsAll150Phase 3France
72NCT04859088
(ClinicalTrials.gov)
September 20, 202115/4/2021Biologics and Partial Enteral Nutrition StudyCombining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's DiseaseCrohn DiseaseDietary Supplement: Partial Enteral NutritionNHS Greater Glasgow and ClydeUniversity of GlasgowRecruiting16 YearsN/AAll80N/AUnited Kingdom
73EUCTR2020-004301-31-SK
(EUCTR)
18/09/202128/04/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's diseaseA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy Moderately to severely active Crohn’s disease (CD)
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO
Product Name: Vedolizumab
INN or Proposed INN: Vedolizumab
Other descriptive name: MLN0002
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of;Canada;United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary
74EUCTR2020-004461-40-IT
(EUCTR)
15/09/202118/10/2021Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: deucravacitinib
Product Code: [BMS-986165]
INN or Proposed INN: deucravacitinib
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan
75EUCTR2020-004775-40-DE
(EUCTR)
14/09/202104/06/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Turkey;Czech Republic;Mexico;Canada;Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
76NCT04847739
(ClinicalTrials.gov)
September 13, 20211/4/2021Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)Perianal Fistula;Crohn's DiseaseProcedure: Seton Placement;Drug: AVB-114Avobis Bio, LLCAlimentiv Inc.Recruiting18 Years70 YearsAll60Phase 2United States
77EUCTR2019-001866-14-DE
(EUCTR)
10/09/202111/06/2021Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of
78EUCTR2019-002687-27-LT
(EUCTR)
03/09/202129/06/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
79NCT05033340
(ClinicalTrials.gov)
September 1, 202123/8/2021The Efficacy and Safety of Oral Etrasimod as Therapy for Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Etrasimod;Drug: PlaceboSamia Hassan El-ShishtawyArena PharmaceuticalsNot yet recruiting18 Years80 YearsAll5Phase 2/Phase 3NULL
80NCT03935451
(ClinicalTrials.gov)
September 1, 202123/4/2019Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel DiseaseA Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot StudyIBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal DisordersDrug: Apixaban 2.5 milligram;Drug: Placebo Oral TabletMcMaster UniversityNULLRecruiting18 YearsN/AAll60Early Phase 1Canada
81NCT03992469
(ClinicalTrials.gov)
September 202118/6/2019Study to Evaluate Safety, Tolerability and Efficacy of Oral B-FAHF-2 in Mild-to-Moderate Crohn's DiseaseStudy to Evaluate Safety, Tolerability, and Early Efficacy of Oral B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's DiseaseCrohn's DiseaseDrug: BFAHF-2;Drug: PlaceboIcahn School of Medicine at Mount SinaiNULLNot yet recruiting18 Years30 YearsAll28Phase 1United States
82NCT05040464
(ClinicalTrials.gov)
August 26, 202126/8/2021Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled TrialComparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled TrialCrohn Disease;Azathioprine;MethotrexateDrug: AZA capsules;Drug: MTX;Biological: blood sampleCentre Hospitalier Universitaire, AmiensNULLRecruiting18 YearsN/AAll166Phase 3France
83EUCTR2020-004301-31-HR
(EUCTR)
17/08/202102/09/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's diseaseA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy Moderately to severely active Crohn’s disease (CD)
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO
Product Name: Vedolizumab
INN or Proposed INN: Vedolizumab
Other descriptive name: MLN0002
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
84JPRN-jRCT2031210210
16/08/202128/07/2021A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's DiseaseA master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's Disease - I6T-MC-AMAZ Ulcerative Colitis / Crohn's Disease
-
Drug: Mirikizumab
Administered SC
Other Name: LY3074828
Yoshimoto YusukeNULLRecruitingNot applicableNot applicableBoth5Phase 3United States;Japan
85JPRN-jRCT2031200345
11/08/202105/02/2021A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease Crohn Disease-Ustekinumab
Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.
Open- Label UstekinumabIntravenous (IV): Induction Period
UstekinumabSubcutaneous (SC) Every8 Weeks (q8w): Maintenance Period
Ustekinumab SC Every12 Weeks (q12w): Maintenance Period

-Placebo
Matching placebo will be administered as SC injection.
UstekinumabSubcutaneous (SC) Every8 Weeks (q8w): Maintenance Period
Ustekinumab SC Every12 Weeks (q12w): Maintenance Period
Nishikawa KazukoNULLRecruiting>= 2age old< 18age oldBoth90Phase 3United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan
86EUCTR2020-004775-40-LT
(EUCTR)
10/08/202107/06/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
87EUCTR2020-004301-31-HU
(EUCTR)
06/08/202128/04/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's diseaseA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy Moderately to severely active Crohn’s disease (CD)
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO
Product Name: Vedolizumab
INN or Proposed INN: Vedolizumab
Other descriptive name: MLN0002
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
88EUCTR2020-004461-40-DE
(EUCTR)
04/08/202112/05/2021Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: deucravacitinib
Product Code: BMS-986165
INN or Proposed INN: deucravacitinib
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2Germany;Japan;Romania;Poland;Brazil;Belgium;Canada;Mexico;Hungary;United Kingdom;Czechia;Korea, Republic of;China;Netherlands;Denmark;Australia;France;Switzerland;Italy;Israel;Russian Federation;Ireland;Spain;Taiwan;Portugal;United States
89EUCTR2020-004775-40-CZ
(EUCTR)
04/08/202109/06/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Romania;Croatia;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
90NCT04970446
(ClinicalTrials.gov)
August 1, 202118/7/2021The MIRO II Study: Microbial Restoration in Inflammatory Bowel DiseasesThe MIRO II Study: Microbial Restoration in Inflammatory Bowel DiseasesFecal Microbiota Transplantation;Crohn Disease;Inflammatory Bowel Diseases;MicrobiomeDrug: Antibiotics;Dietary Supplement: Dietician designed diet;Drug: FMT;Other: PlaceboSt Vincent's Hospital MelbourneThe Queen Elizabeth Hospital;BiomeBank Adelaide;The University of Queensland;Monash UniversityNot yet recruiting18 Years70 YearsAll120Phase 2/Phase 3NULL
91NCT05013905
(ClinicalTrials.gov)
July 28, 202113/8/2021A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's DiseaseA Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: PRA023 IV;Device: Companion diagnostic (CDx)Prometheus Biosciences, Inc.NULLRecruiting18 YearsN/AAll50Phase 2United States
92EUCTR2019-000824-17-HR
(EUCTR)
28/07/202121/10/2021A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease Patients with Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: BT-11
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Belarus;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Austria;North Macedonia;Poland;Croatia;Albania;Georgia;Bulgaria;Netherlands;Moldova, Republic of;Bosnia and Herzegovina
93EUCTR2019-002687-27-DE
(EUCTR)
27/07/202113/04/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
94EUCTR2020-004775-40-IT
(EUCTR)
15/07/202127/01/2022A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: [APD334]
INN or Proposed INN: etrasimod L-arginine
Product Name: Etrasimod
Product Code: [APD334]
INN or Proposed INN: etrasimod L-arginine
ARENA PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Spain;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
95ChiCTR2100048717
2021-07-012021-07-13Clinical trial of the efficacy and safety of dipyridamole adjuvant therapy in children with IBDClinical trial of the efficacy and safety of dipyridamole adjuvant therapy in children with IBD Crohn's diseaseTwo groups:Oral dipyridamole;Guangzhou Women and Children's Medical CenterNULLPending318BothTwo groups:50;China
96NCT04828031
(ClinicalTrials.gov)
July 1, 202129/3/2021Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel DiseaseVitamin D Regulation of a4ß7+ B Cell Immunophenotypes and Mucosal Antibody Response to Commensal Gut Bacteria in Patients With Inflammatory Bowel DiseaseInflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseDrug: Vitamin DStanford UniversityDoris Duke Charitable FoundationRecruiting18 YearsN/AAll50Phase 1United States
97NCT04701411
(ClinicalTrials.gov)
June 30, 20216/1/2021A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's DiseaseA Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects With Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 WeeksCrohn's Disease;Complex Perianal FistulaBiological: DarvadstrocelTakedaTakeda Development Center Americas, Inc.Recruiting4 Years17 YearsAll20Phase 3Israel;Japan;Netherlands;Poland;Spain
98JPRN-jRCT2033200314
30/06/202120/01/2021A Study of Darvadstrocel for Treating of Complex Perianal Fistula in Children and Teenagers With Crohn's DiseaseA Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn's Disease over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks Crohn's Disease, Complex Perianal FistulaDarvadstrocel (Cx601), 24 mL suspension of 120 million cells as a perilesional injection, once on Day 0.Shikamura MitsuhiroNULLRecruiting>= 4age old< 18age oldBoth20Phase 3Italy;Netherlands;Poland;Spain;Israel;Japan
99EUCTR2020-004301-31-LT
(EUCTR)
25/06/202121/04/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's diseaseA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy Moderately to severely active Crohn’s disease (CD)
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO
Product Name: Vedolizumab
INN or Proposed INN: Vedolizumab
Other descriptive name: MLN0002
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of
100NCT04372108
(ClinicalTrials.gov)
June 24, 202130/4/2020A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative ColitisAn Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records DatabaseCrohn Disease;Colitis, UlcerativeDrug: Ustekinumab;Drug: Other Biologic TherapiesJanssen Scientific Affairs, LLCNULLRecruiting18 YearsN/AAll1056United States
101EUCTR2019-002687-27-LV
(EUCTR)
17/06/202111/03/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Israel;Switzerland;Italy;India;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation
102EUCTR2019-002687-27-FR
(EUCTR)
10/06/202104/05/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
103JPRN-jRCT2031200371
04/06/202119/02/2021A Study of Vedolizumab, given every 4 weeks, in Japanese Participants with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseAn Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who Experienced Secondary Loss of Response During Maintenance Therapy with Vedolizumab IV Administered Every 8 Weeks (Q8W) Ulcerative Colitis, Crohn's DiseaseVedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase.Shikamura MitsuhiroNULLRecruiting>= 18age old<= 80age oldBoth158Phase 3Japan
104NCT04738942
(ClinicalTrials.gov)
June 4, 20212/2/2021A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseAn Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W)Ulcerative Colitis;Crohn's DiseaseDrug: VedolizumabTakedaNULLRecruiting18 Years80 YearsAll158Phase 3Japan
105EUCTR2020-004301-31-ES
(EUCTR)
02/06/202101/09/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's diseaseA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy Moderately to severely active Crohn’s disease (CD)
MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO
Product Name: Vedolizumab
INN or Proposed INN: Vedolizumab
Other descriptive name: MLN0002
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
106NCT04073472
(ClinicalTrials.gov)
June 1, 202123/8/2019Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn'sA Phase I Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the PouchCrohn's Disease;Fistula;Anal Fistula;Pouch, Ileal;Pouches, IleoanalDrug: mesenchymal stem cells (MSCs)The Cleveland ClinicNULLWithdrawn18 Years75 YearsAll0Phase 1United States
107NCT04919252
(ClinicalTrials.gov)
June 1, 20216/4/2021Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel DiseaseEfficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel DiseaseCrohn's Disease and Ulcerative ColitisDrug: VedolizumabYonsei UniversityNULLNot yet recruiting19 Years70 YearsAll60Phase 3Korea, Republic of
108NCT04617184
(ClinicalTrials.gov)
June 1, 20212/11/2020Registry and Biorepository for IBD in Central TexasRegistry and Biorepository for the Study of Inflammatory Bowel Diseases in Central TexasCrohn Disease;Ulcerative Colitis;Inflammatory Bowel DiseasesOther: NO INTERVENTIONUniversity of Texas at AustinNULLRecruiting18 Years100 YearsAll1000United States
109NCT04643483
(ClinicalTrials.gov)
June 202119/11/2020A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's DiseaseA Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Certolizumab pegol;Drug: Adalimumab;Drug: PlaceboUCB Biopharma SRLNULLWithdrawn6 Years17 YearsAll0Phase 3NULL
110NCT04844606
(ClinicalTrials.gov)
May 26, 202112/4/2021A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Ulcerative Colitis Chronic;Inflammatory Bowel Diseases;Crohn's DiseaseDrug: MirikizumabEli Lilly and CompanyNULLRecruiting2 Years19 YearsAll185Phase 3United States;Israel;Japan;Korea, Republic of
111EUCTR2019-000824-17-BG
(EUCTR)
26/05/202110/05/2021A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease Patients with Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: BT-11
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Turkey;North Macedonia;Poland;Croatia;Bulgaria;Albania;Georgia;Bosnia and Herzegovina
112NCT04842149
(ClinicalTrials.gov)
May 21, 20218/4/2021The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's DiseaseThe Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled StudyCrohn DiseaseDietary Supplement: Bif195 capsules;Dietary Supplement: Placebo capsulesHvidovre University HospitalChr HansenRecruiting18 Years75 YearsAll60N/ADenmark
113EUCTR2020-002674-26-DE
(EUCTR)
19/05/202117/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
114EUCTR2019-002687-27-IT
(EUCTR)
18/05/202130/07/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: MIRIKIZUMAB
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
115NCT04898530
(ClinicalTrials.gov)
May 15, 202113/5/2021Diet Patterns in IBD in Central TexasA Cross-sectional Assessment of Diet in Patients With IBD in Central TexasInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisOther: NO INTERVENTIONUniversity of Texas at AustinNULLRecruiting18 YearsN/AAll500United States
116NCT05034458
(ClinicalTrials.gov)
May 14, 202112/6/2021Diet in Pediatric Crohn´s Disease Treated With BiologicsDiet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.Crohn's DiseaseDietary Supplement: Crohn's disease exclusion dietHospital Italiano de Buenos AiresNULLRecruiting1 Month18 YearsAll40N/AArgentina
117EUCTR2018-002629-51-CZ
(EUCTR)
12/05/202102/03/2021A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Czechia;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
118EUCTR2020-004775-40-NL
(EUCTR)
11/05/202102/02/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1265Phase 2;Phase 3Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
119NCT04877990
(ClinicalTrials.gov)
May 7, 20214/5/2021A Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants With Crohn's Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative ColitisCrohn Disease;Ulcerative ColitisDrug: BMS-986165Bristol-Myers SquibbNULLRecruiting18 YearsN/AAll300Phase 2United States;Australia;Brazil;China;Germany;Hungary;Italy;Japan;Poland;Romania;Russian Federation;United Kingdom
120NCT03870334
(ClinicalTrials.gov)
May 5, 20218/3/2019Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's DiseaseA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: BT-11 1,000 mg;Drug: PlaceboLandos Biopharma Inc.NULLRecruiting18 Years75 YearsAll150Phase 2United States;Bulgaria;Poland
121EUCTR2019-001673-93-ES
(EUCTR)
23/04/202109/02/2021A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials Crohns disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Korea, Republic of
122NCT04804046
(ClinicalTrials.gov)
April 15, 202111/3/2021Synbiotics and Post-op Crohn's DiseaseDefining Microbial and Immune Changes Following Synbiotic Supplementation in Post-operative Crohn's Disease PatientsCrohn's DiseaseDietary Supplement: Synbiotic;Other: Digestible MaltodextrinUniversity of AlbertaW. Garfield Weston FoundationNot yet recruiting18 Years75 YearsAll36N/ACanada
123EUCTR2017-000725-12-DK
(EUCTR)
07/04/202114/10/2020A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden
124NCT04673357
(ClinicalTrials.gov)
April 6, 202114/12/2020A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ustekinumab;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll90Phase 3United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom
125NCT04151225
(ClinicalTrials.gov)
April 5, 20214/11/2019Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's DiseaseA Multicentre, Randomised, Double-blind, Placebo-controlled, Repeat Dose, Dose-ranging Phase 2a/2b Study to Evaluate the Safety, Tolerability and Efficacy of an Anti-oncostatin M Monoclonal Antibody (GSK2330811) in Patients With Moderate to Severe Crohn's DiseaseCrohns DiseaseDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLWithdrawn18 YearsN/AAll0Phase 2NULL
126NCT04791878
(ClinicalTrials.gov)
April 1, 20216/3/2021Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's DiseaseA Phase I Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's DiseasePerianal Fistula Due to Crohn's Disease (Disorder)Drug: Mesenchymal stem cellsAmy LightnerNULLRecruiting13 Years17 YearsAll10Phase 1United States
127EUCTR2017-000725-12-SE
(EUCTR)
30/03/202120/08/2020A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden
128JPRN-jRCT2031200406
27/03/202110/03/2021A Study of JNJ-64304500 as Add-on Therapy in Participants with Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET Crohn DiseaseGroup 1- Standard of Care (SOC) Biological Therapy: Adalimumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo subcutaneous (SC) injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to adalimumab or its biosimilar as SOC therapy.

Group 2: SOC Biological Therapy: Ustekinumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo SC injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to ustekinumab as SOC therapy.
Numaguchi HirotakaNULLNot Recruiting>= 18age old<= 65age oldBoth70Phase 2Canada;France;Germany;Italy;Spain;United States Of America;Japan
129NCT04682522
(ClinicalTrials.gov)
March 21, 20219/12/2020Flagyl Microbiome in Crohn's DiseaseDoes the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's DiseaseCrohn DiseaseDrug: Metronidazole OralUniversity of LouisvilleNULLRecruiting20 Years80 YearsAll36Phase 4United States
130NCT04795960
(ClinicalTrials.gov)
March 18, 20219/3/2021Microbiome Modification to Enhance Stelara Response in Crohn's DiseaseMicrobiome Modification to Enhance Stelara Response in Crohn's DiseaseCrohn DiseaseDietary Supplement: Low serine diet;Dietary Supplement: High serine dietUniversity of MichiganKenneth Rainin FoundationRecruiting18 Years70 YearsAll10N/AUnited States
131EUCTR2017-001976-48-NL
(EUCTR)
17/03/202108/10/2020A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan
132EUCTR2019-004225-24-DE
(EUCTR)
17/03/202117/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
133EUCTR2019-002942-19-DK
(EUCTR)
12/03/202105/11/2020Nordic study of treatment strategy in inflammatory bowel diseaseNORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile Crohn's disease and Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Imurel
INN or Proposed INN: Azathioprine
Trade Name: Puri-nethol
INN or Proposed INN: MERCAPTOPURINE
Region Örebro länNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 4Denmark
134NCT04263831
(ClinicalTrials.gov)
March 11, 20217/2/2020LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASELOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASECrohn DiseaseDrug: Interleukin-2 (aldesleukin).Boston Children's HospitalNULLRecruiting18 Years80 YearsAll30Phase 1/Phase 2United States
135NCT04646187
(ClinicalTrials.gov)
March 11, 202120/11/2020De-escalation of Anti-TNF Therapy in Inflammatory Bowel DiseaseDe-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level MonitoringInflammatory Bowel Diseases;Crohn Disease;Colitis, UlcerativeBiological: Infliximab;Biological: AdalimumabUniversity Medical Center GroningenEuropean Crohn´s and Colitis Organisation;Bühlmann Laboratories AGRecruiting12 Years25 YearsAll148Phase 4Belgium;Netherlands;Spain
136NCT04655807
(ClinicalTrials.gov)
March 3, 202130/11/2020A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-64304500;Drug: Placebo;Drug: Adalimumab;Drug: UstekinumabJanssen Research & Development, LLCNULLWithdrawn18 Years65 YearsAll0Phase 2United States;Canada;France;Germany;Italy;Japan;Spain;Sweden
137NCT04921033
(ClinicalTrials.gov)
March 1, 20214/6/2021Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's DiseaseExclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease (XENIC): an Open-label, Multicenter, Prospective, Randomized Clinical TrialCrohn Disease;Nutrient; Excess;Remission/RegressionDietary Supplement: EEN (Nestle Modulen®);Drug: Standart of careDuzce UniversityNULLRecruiting18 Years75 YearsAll256Phase 3Turkey
138EUCTR2019-002687-27-SK
(EUCTR)
25/02/202108/12/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
139NCT04761952
(ClinicalTrials.gov)
February 13, 202114/2/2021N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's DiseaseN-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease:a Prospective Randomized Controlled TrialInflammatory Bowel Diseases;Crohn Disease;Polyunsaturated Acid LipidosisDrug: azathioprine;Drug: infliximab;Drug: N-3 Polyunsaturated Fatty AcidsSixth Affiliated Hospital, Sun Yat-sen UniversityNULLNot yet recruiting18 Years80 YearsAll236N/ANULL
140EUCTR2019-004225-24-BE
(EUCTR)
08/02/202125/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
141JPRN-UMIN000043165
2021/02/0131/01/2021Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel diseaseSafety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease Crohn's disease, Ulcerative colitis, IBDUwitching from originator infliximab to infliximab biosimilar CT-P13Fukuoka University Chikushi HospitalNULLPendingNot applicableNot applicableMale and Female220Not selectedJapan
142EUCTR2020-003193-48-NL
(EUCTR)
25/01/202121/11/2020A Phase 3 Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease.A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel inthe Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn’s Disease over aPeriod of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks. - Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Crohn’s Disease. Complex Perianal Fistulas in Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Darvadstrocel
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3Spain;Poland;Israel;Netherlands;Italy;Japan
143EUCTR2017-001976-48-BE
(EUCTR)
22/01/202126/01/2021A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan
144EUCTR2019-001673-93-BE
(EUCTR)
19/01/202123/11/2020A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials Crohns disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
145EUCTR2020-002674-26-SK
(EUCTR)
14/01/202120/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
146EUCTR2020-002674-26-CZ
(EUCTR)
13/01/202118/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
147EUCTR2020-002701-26-IT
(EUCTR)
12/01/202107/04/2021A clinical study to evaluate the safety and effectiveness of JNJ-64304500 as an add-on therapy to standard of care biologic therapy with anti-tumor necrosis factor alpha or anti-interleukin 12/23 in responder not remitter participants with active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: JNJ-64304500
Product Code: [JNJ-64304500]
INN or Proposed INN: JNJ-64304500
Other descriptive name: sezione * D.3.6.2.1 - valore: 400mg alla settimana 0, in seguito 200mg ogni due settimane
JANSSEN CILAG INTERNATIONAL NVNULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;United States;Canada;Spain;Germany;Japan;Italy;Sweden
148EUCTR2020-002674-26-HU
(EUCTR)
06/01/202120/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
149EUCTR2019-004225-24-HU
(EUCTR)
05/01/202120/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Russian Federation;Germany;United Kingdom;Japan;Poland;Belgium;United States;Hungary
150ChiCTR2000036845
2021-01-012020-08-25A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's diseaseA single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease Crohn's diseaseProctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concentration is going to be monitored at week 8, 16, 24, 32 and 40 after inclusion: 1.If serum trough concentration=11.7 g/ mL, continue&#;Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed at week 8, 16, 24, 32, and 40 after inclusion: 1.If the clinical response is achieved, continue to administer 40mg once every ;Xinhua Hospital Affiliated to Shanghai Jiaotong University School of MedicineNULLPending1870BothProctive treatment drug monitoring group:60;Reactive treatment drug monitoring group:60;Phase 4China
151NCT04713631
(ClinicalTrials.gov)
January 20213/12/2020Safety and Efficacy of Artesunate & Curcumin in Crohn's DiseasePhase 2a Randomised Double-blind Placebo-controlled Trial to Assess Safety, Efficacy of Artesunate & Curcumin in Crohn's Disease Patients, Who Continue to Have Mild to Moderate Disease Activity on an Adequate Dose of AzathioprineCrohn's DiseaseDrug: Artesunate;Drug: Curcumin;Drug: Placebo A;Drug: Placebo CSanjay Gandhi Postgraduate Institute of Medical SciencesSt George's University of London, London, UKNot yet recruiting18 Years65 YearsAll40Phase 2India
152NCT04118088
(ClinicalTrials.gov)
December 22, 20204/10/2019A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal FistulaPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal FistulaCrohn's Disease;Complex Perianal FistulaBiological: DarvadstrocelTakedaTakeda Development Center Americas, Inc.Recruiting18 YearsN/AAll50Phase 4Austria;Czechia;France;Germany;Israel;Spain
153NCT04224558
(ClinicalTrials.gov)
December 15, 20204/4/2018Stem Cell Transplantation in Crohn's DiseaseAutologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's DiseaseCrohn DiseaseDrug: Mesna;Drug: Cyclophosphamide;Drug: Filgrastim;Procedure: Apheresis catheter placement;Procedure: Leukapheresis;Drug: Fludarabine;Drug: Methylprednisolone;Drug: Diphenhydramine;Drug: Acetaminophen;Drug: anti-thymocyte globulin (rabbit);Drug: lymphocyte immune globulin;Biological: Peripheral Blood Stem Cell Infusion;Drug: CytoxanCedars-Sinai Medical CenterNULLRecruiting13 Years28 YearsAll15Phase 1/Phase 2United States
154EUCTR2020-002674-26-IT
(EUCTR)
10/12/202021/05/2021A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. - NA Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: [ABBV-066]
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: [ABBV-066]
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
155NCT03414788
(ClinicalTrials.gov)
December 7, 20208/1/2018Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's DiseasePHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTSInflammatory Bowel DiseaseBiological: PF 06687234;Biological: [124I]IB PF 06687234PfizerNULLWithdrawn18 Years75 YearsAll0Phase 1United States
156EUCTR2020-002674-26-GB
(EUCTR)
02/12/202026/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
157NCT04660136
(ClinicalTrials.gov)
December 1, 20202/12/2020Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric PatientsUsefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric PatientsCrohn's Disease in Pediatric PatientBiological: contrast enhanced ultrasoundYonsei UniversityNULLRecruiting2 Years18 YearsAll20Phase 4Korea, Republic of
158EUCTR2020-002674-26-AT
(EUCTR)
23/11/202018/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada
159NCT04519671
(ClinicalTrials.gov)
November 19, 202017/8/2020Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's DiseaseA Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's DiseasePerianal Crohn Disease;Perianal Fistula;Crohn DiseaseDrug: Mesenchymal Stem Cells;Other: PlaceboAmy LightnerNULLRecruiting18 Years75 YearsAll40Phase 1/Phase 2United States
160EUCTR2020-002674-26-SE
(EUCTR)
19/11/202013/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
161NCT04496063
(ClinicalTrials.gov)
November 16, 202029/6/2020USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD StudyCrohn's DiseaseDrug: Ustekinumab;Drug: PlaceboGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesJanssen, LPRecruiting18 YearsN/AAll146Phase 4France
162NCT04939337
(ClinicalTrials.gov)
November 12, 202010/6/2021A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells(TH-SC01), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.Crohn's DiseaseDrug: TH-SC01Jinling Hospital, ChinaJiangsu Topcel-KH Pharmaceutical Co., LtdEnrolling by invitation18 Years70 YearsAll24Phase 1China
163EUCTR2017-003090-34-DK
(EUCTR)
12/11/202015/06/2020A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Denmark;Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Austria
164EUCTR2019-000333-39-FR
(EUCTR)
07/11/202004/10/2019Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
165NCT04112212
(ClinicalTrials.gov)
November 4, 202025/9/2019NIR FME of Labelled Vedolizumab to Elucidate the Mechanism of Action and Predicting Response in IBD Patients.Near-infrared Fluorescence Molecular Endoscopy Imaging of Labelled Vedolizumab-800CW to Elucidate the Mechanism of Action and Predicting Response in IBD Patients. A Prospective Pilot Intervention Study:Crohn Disease;Colitis, UlcerativeDrug: Vedolizumab-800CW;Device: Fluorescence endoscopy and spectroscopyUniversity Medical Center GroningenNULLRecruiting18 YearsN/AAll35Phase 1Netherlands
166NCT04331639
(ClinicalTrials.gov)
November 1, 202023/3/2020High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic TherapyImplementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or VedolizumabInflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D DeficiencyDietary Supplement: vitamin D3Boston Children's HospitalNULLRecruiting5 Years25 YearsAll50Phase 2United States
167EUCTR2020-002674-26-NL
(EUCTR)
29/10/202015/09/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
168NCT04519684
(ClinicalTrials.gov)
October 28, 202017/8/2020Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's DiseaseA Phase IB/IIA Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the PouchIleal Pouch;Crohn DiseaseDrug: Mesenchymal stem cells;Other: PlaceboAmy LightnerNULLRecruiting18 Years75 YearsAll40Phase 1/Phase 2United States
169NCT04519697
(ClinicalTrials.gov)
October 28, 202017/8/2020Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's DiseaseA Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.Rectovaginal Fistula;Crohn Disease;Crohn Disease of Vulva;Rectolabial; FistulaDrug: Mesenchymal Stem Cells;Other: PlaceboAmy LightnerNULLRecruiting18 Years75 YearsFemale40Phase 1/Phase 2United States
170EUCTR2018-005086-39-BG
(EUCTR)
27/10/202025/06/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
171NCT04590508
(ClinicalTrials.gov)
October 1, 202028/9/2020A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's DiseaseA Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's DiseaseCrohn DiseaseDrug: Xanthohumol;Other: PlaceboNational University of Natural MedicineOregon State University;Pacific Northwest National LaboratoryRecruiting21 Years50 YearsAll32Phase 2United States
172ChiCTR2000035737
2020-10-012020-08-16Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trialApplication of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial Crohn's diseaseExperimental group:The scope of surgical resection was determined by indocyanine green fluorescence angiography;Control group:The scope of surgical resection (2cm away from the lesion site) determined by the physician based on experience;Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of MedicineNULLPending1870BothExperimental group:45;Control group:45;China
173NCT04225819
(ClinicalTrials.gov)
October 1, 20203/1/2020Adjunctive Treatment With Vitamin D3 in Patients With Active IBDAdjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled TrialIBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 DeficiencyDietary Supplement: Vitamin D3;Other: PlaceboMassachusetts General HospitalNULLRecruiting18 YearsN/AAll100N/AUnited States
174NCT04535882
(ClinicalTrials.gov)
October 1, 202028/8/2020Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBDAssociation Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease ColitisLRG LevelsDiagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levelsShowa Inan General HospitalNULLRecruitingN/AN/AAll125Japan
175NCT04276636
(ClinicalTrials.gov)
October 202017/2/2020Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D DeficiencyExploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency,a Prospective Cohort StudyCrohn's Disease;Vitamin D Deficiency;Vitamin D SupplementDrug: Caltrate PillSecond Affiliated Hospital of Wenzhou Medical UniversityNULLNot yet recruitingN/AN/AAll60Early Phase 1China
176NCT04308850
(ClinicalTrials.gov)
October 202024/2/2020Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D DeficiencyExploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency,a Prospective Cohort StudyCrohn's Disease;Vitamin D Deficiency;Vitamin D SupplementDrug: Vitamin D dropsSecond Affiliated Hospital of Wenzhou Medical UniversityNULLNot yet recruitingN/AN/AAll60Early Phase 1China
177NCT04524611
(ClinicalTrials.gov)
September 30, 202020/8/2020Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF TherapyCrohn's Disease (CD)Drug: Risankizumab;Drug: UstekinumabAbbVieNULLRecruiting18 Years80 YearsAll508Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
178EUCTR2020-001811-26-NL
(EUCTR)
30/09/202008/07/2020IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Netherlands
179NCT04223518
(ClinicalTrials.gov)
September 20, 20206/1/2020Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel DiseaseInflammatory Bowel Diseases;Ulcerative Colitis;Crohn DiseaseDietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: PlaceboMonisha Hitesh ShahNULLRecruiting6 Years30 YearsAll43Early Phase 1United States
180EUCTR2018-004614-18-DK
(EUCTR)
08/09/202005/08/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
181EUCTR2018-004346-42-IT
(EUCTR)
03/09/202024/05/2021An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease - 52-Week Phase 2b/3 Crohn's Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
Product Name: NA
Product Code: [NA]
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anticorpo monoclonale umano anti-Interleuchina-23 Immunoglobulina G2 (IgG2); precedentemente denominato MEDI2070 e AMG 139
ALLERGAN LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
182JPRN-jRCT2031200117
01/09/202011/09/2020A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohns DiseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohns Disease Crohns DiseaseBiological: CT-P13 SC (Infliximab)
Other: Placebo SC
Ishida TetsuyaCelltrionNot Recruiting>= 18age old<= 75age oldBoth600Phase 3US;Latvia;Czech Republic;France;Poland;Germany;Greece;Hungary;Spain;Austria;Bulgaria;Croatia;Japan
183ChiCTR2100048113
2020-09-012021-07-02Study on the efficacy of selenium supplementation in patients with Crohn's disease and low selenium levelStudy on the efficacy of selenium supplementation in patients with Crohn's disease and low selenium level Crohn's DiseaseExperimental group:selenium supplementation;Control group:N/A;Sir Run Run Shaw Hospital, Zhejiang University School of MedicineNULLRecruiting1865BothExperimental group:60;Control group:30;China
184ChiCTR2000037094
2020-09-012020-08-26Discovery and detection of a novel antigen for Crohn’s disease (CD)Discovery and detection of a novel antigen for Crohn’s disease (CD) Inflammatory Bowel DiseaseGold Standard:Chinese consensus on diagnosis and treatment in inflammatory bowel disease (2018, Beijing);Index test:anti-CABP, pANCA, ASCA;The First Affiliated Hospital of Anhui Medical UniversityNULLCompleted1880BothTarget condition:100;Difficult condition:100China
185NCT04502303
(ClinicalTrials.gov)
September 20204/8/202018F-FDG and 68Ga-FAPI PET/CT in Crohn's DiseaseA Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CTCrohn DiseaseDiagnostic Test: 18F-FDG and 68Ga-FAPI PET/CTPeking Union Medical College HospitalNULLNot yet recruiting18 YearsN/AAll30Phase 2NULL
186NCT04398836
(ClinicalTrials.gov)
September 202018/7/2019Preoperative Nutrition for Crohn's Disease PatientsPreoperative Nutrition for Crohn's Disease PatientsMalnutrition;Crohn DiseaseDietary Supplement: Exclusive Enteral Nutrition;Other: High energy / protein diet.;Other: Standard nutritionTel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 Years70 YearsAll144Phase 3Israel
187EUCTR2018-004614-18-HR
(EUCTR)
24/08/202023/11/2020Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
188EUCTR2017-002491-10-AT
(EUCTR)
19/08/202011/05/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czechia;Czech Republic;Spain;Austria;Israel;Germany
189NCT03943446
(ClinicalTrials.gov)
August 14, 20207/5/2019A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After SurgeryA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease RecurrenceCrohn DiseaseDrug: TAK-018;Drug: TAK-018 PlaceboTakedaTakeda Development Center Americas, Inc.Active, not recruiting18 YearsN/AAll96Phase 2United States;Austria;France;Germany;United Kingdom;Netherlands
190EUCTR2019-002895-14-GB
(EUCTR)
05/08/202002/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - CULTIVATE APD334-202 Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Slovenia;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China
191EUCTR2019-002895-14-NL
(EUCTR)
05/08/202023/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
192NCT04976491
(ClinicalTrials.gov)
August 1, 202014/11/2019Based on the Special Disease Management of Crohn's Disease Diet StudiesBased on the Special Disease Management of Crohn's Disease Diet Studies --a Multicenter, Randomized, Controlled and Open Label StudyInflammatory Bowel DiseasesDietary Supplement: CD-C-FoodSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting6 Years15 YearsAll5China
193NCT04362735
(ClinicalTrials.gov)
August 1, 202019/4/2020Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological TherapyEfficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy: a Brazilian Multicentric Observational Real-world StudyCrohn DiseaseDrug: VedolizumabPontifícia Universidade Católica do ParanáTakedaNot yet recruiting18 YearsN/AAll100NULL
194EUCTR2019-002895-14-PT
(EUCTR)
27/07/202006/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Portugal;Belarus;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
195EUCTR2017-002491-10-FR
(EUCTR)
17/07/202009/03/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czech Republic;Spain;Austria;Germany;United Kingdom
196NCT04312659
(ClinicalTrials.gov)
July 15, 20203/3/2020A Study of Infliximab in the Treatment of Chinese Children With Crohn's DiseaseA Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's DiseaseCrohn DiseaseDrug: InfliximabJohnson & Johnson (China) Investment Ltd.NULLActive, not recruiting6 Years17 YearsAll39China
197EUCTR2019-001673-93-HU
(EUCTR)
07/07/202009/06/2020A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials Crohns disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
198NCT04712032
(ClinicalTrials.gov)
July 1, 202014/1/2021Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage RatesA PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSESColo-rectal Cancer;Crohn Disease;Resectable Colorectal CarcinomaDrug: ICG-guided bowel perfusion assessmentLeiden University Medical CenterMedical Center Haaglanden;Catharina Ziekenhuis Eindhoven;Haga Hospital;Jeroen Bosch Ziekenhuis;Amphia Hospital;Alrijne Hospital;IJssellandRecruiting18 YearsN/AAll978Phase 3Netherlands
199EUCTR2019-003335-37-DE
(EUCTR)
29/06/202027/11/2019A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease.A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants with Moderately to Severely Active Crohn’s Disease: Intervention JNJ-67864238 - PRISM-SCARLET Treatment of moderately to severely active Crohn’s disease with JNJ-67864238.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: JNJ-67864238
Product Code: JNJ-67864238
INN or Proposed INN: Not available
Other descriptive name: PTG-200
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;Argentina;Poland;Russian Federation;Germany;Italy
200EUCTR2017-001240-35-FR
(EUCTR)
22/06/202009/03/2020A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
501Phase 3Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;China;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia
201NCT04232553
(ClinicalTrials.gov)
June 22, 202015/1/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's DiseaseCrohn's DiseaseDrug: MirikizumabEli Lilly and CompanyNULLRecruiting18 YearsN/AAll778Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom
202EUCTR2017-002491-10-DE
(EUCTR)
22/06/202009/03/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czechia;Czech Republic;Spain;Austria;Israel;Germany
203NCT04163016
(ClinicalTrials.gov)
June 19, 202024/10/2019A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque PsoriasisDrug: Pharmacokinetics of certolizumab pegolUCB Biopharma S.P.R.L.NULLRecruiting18 YearsN/AFemale20Phase 1United States;Canada;France;Germany;Netherlands;Spain;Switzerland
204EUCTR2018-004346-42-AT
(EUCTR)
18/06/202021/01/2020A study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severly Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Astrazeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2;Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Korea, Republic of
205NCT04188990
(ClinicalTrials.gov)
June 15, 20202/12/2019Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related MalnutritionEvaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related MalnutritionPancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal CancerDietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current careHospital Galdakao-UsansoloNULLActive, not recruiting18 YearsN/AAll900N/ASpain
206NCT04397263
(ClinicalTrials.gov)
June 10, 202018/5/2020A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseCrohns DiseaseDrug: GuselkumabJanssen Pharmaceutical K.K.NULLRecruiting18 YearsN/AAll25Phase 3Japan
207JPRN-JapicCTI-205298
10/6/202026/05/2020A Study of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease Crohn's DiseaseIntervention name : Guselkumab
INN of the intervention : Guselkumab
Dosage And administration of the intervention : Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Janssen Pharmaceutical K.K.NULLrecruiting18BOTH25Phase 3Japan
208EUCTR2017-002491-10-ES
(EUCTR)
03/06/202006/03/2020Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE) - ASPIRE Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czech Republic;Spain;Austria;Germany;United Kingdom
209EUCTR2018-004346-42-BG
(EUCTR)
28/05/202008/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany
210EUCTR2019-002687-27-NL
(EUCTR)
28/05/202018/05/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
211EUCTR2019-002895-14-BG
(EUCTR)
21/05/202023/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
212EUCTR2018-004614-18-LT
(EUCTR)
20/05/202025/11/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
213EUCTR2018-004346-42-RO
(EUCTR)
19/05/202018/03/2022An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;South Africa;Germany
214EUCTR2019-001673-93-DE
(EUCTR)
19/05/202002/03/2020A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
INN or Proposed INN: Spesolilmab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
215NCT04362254
(ClinicalTrials.gov)
May 15, 202023/4/2020A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous TrialsAn Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Fistulising Crohn's Disease Who Have Completed Previous Spesolimab TrialsCrohn DiseaseDrug: SpesolimabBoehringer IngelheimNULLRecruiting18 YearsN/AAll20Phase 2Austria;Belgium;Germany;Korea, Republic of;Netherlands
216EUCTR2019-002895-14-ES
(EUCTR)
14/05/202015/05/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
217EUCTR2019-000176-41-HU
(EUCTR)
07/05/202016/03/2020A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy
218EUCTR2019-000886-19-AT
(EUCTR)
06/05/202006/09/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2France;United States;Austria;Netherlands;Germany;United Kingdom
219EUCTR2019-000333-39-BE
(EUCTR)
04/05/202021/01/2020Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Takeda Development Center Americas, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany
220EUCTR2019-002895-14-NO
(EUCTR)
04/05/202020/12/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;Belarus;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
221ChiCTR2000031344
2020-05-012020-03-28Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical studyEndoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study Crohn's diseaseGroup 1:Endoscopic Stricturotomy;Group 2:Endoscopic Stricturotomy combined with local bleomycin injection;The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of MedicineNULLPendingBothGroup 1:35;Group 2:35;China
222EUCTR2019-002687-27-HU
(EUCTR)
28/04/202009/03/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 Crohn´s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
223EUCTR2019-004219-29-NL
(EUCTR)
21/04/202004/02/2020Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s DiseasePersonalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study” - PAZAZ Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Azithromycin
Product Name: Azithromycin
INN or Proposed INN: Azithromycin
Other descriptive name: AZITHROMYCIN
Trade Name: Metronidazole
Product Name: Metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: METRONIDAZOLE
Amsterdam UMCNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Canada;Israel;Netherlands
224NCT03905109
(ClinicalTrials.gov)
April 15, 20203/4/2019Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's DiseaseA Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety of ABX464 Compared With Placebo in Patients With Moderate to Severe Active Crohn's Disease Who Have Inadequate Response, Loss of Response, or Intolerance to Prior Amino-salicylates, Immunosuppressant Treatment, Biologics, and/or Corticosteroid TreatmentCrohn DiseaseDrug: ABX464;Drug: PlaceboAbivax S.A.NULLNot yet recruiting18 Years75 YearsAll30Phase 2Belgium
225EUCTR2018-004346-42-BE
(EUCTR)
15/04/202003/03/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
226NCT04239248
(ClinicalTrials.gov)
April 1, 202027/11/2019Tasty&Healthy Dietary Approach for Crohn's DiseaseTasty&Healthy is Not a Diet But a Dietary Approach: Randomized Controlled Trials of Excluding Pro-inflammatory Nutrients for Inducing and Maintaining Remission in Crohn's DiseaseCrohn DiseaseDietary Supplement: Tasty&Healthy intervention group;Dietary Supplement: EEN intervention groupShaare Zedek Medical CenterNULLRecruiting6 Years24 YearsAll192N/AIsrael
227EUCTR2018-004346-42-CZ
(EUCTR)
24/03/202022/01/2020A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: MEDI2070
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: MEDI2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
221Phase 2;Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of
228EUCTR2019-001337-13-FR
(EUCTR)
18/03/202002/03/2020USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD studyUSTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study - USTAP patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: STELARA
Trade Name: STELARA 90 mg solution for injection in pre-filled syringe
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
146Phase 4France
229EUCTR2018-002629-51-GB
(EUCTR)
16/03/202008/01/2020A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
230EUCTR2017-002491-10-CZ
(EUCTR)
10/03/202027/11/2019Postauthorization Safety Study of Darvadstrocel Repeat AdministrationPostauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4France;Czechia;Czech Republic;Spain;Austria;Germany;United Kingdom
231EUCTR2017-001976-48-FR
(EUCTR)
06/03/202009/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Portugal;Taiwan;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;China;Japan;Korea, Republic of
232NCT03492944
(ClinicalTrials.gov)
March 6, 202012/2/2018Contrast Enhanced Ultrasound in Human Crohn's Disease-LumasonContrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI EnterographyCrohn DiseaseDrug: Ultrasound Microbubble Contrast Agent;Device: Ultrasound ImagingChildren's Hospital Medical Center, CincinnatiNULLRecruiting10 Years18 YearsAll25United States
233EUCTR2019-000886-19-NL
(EUCTR)
06/03/202017/09/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Austria;Germany;Netherlands;United Kingdom
234NCT04014517
(ClinicalTrials.gov)
March 1, 20208/7/2019Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease PatientsEffect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease PatientsCrohn DiseaseOther: Standard of Care;Dietary Supplement: ImmunonutritionIstituto Clinico HumanitasNULLNot yet recruiting18 YearsN/AAll350N/ANULL
235ChiCTR2000029323
2020-03-012020-01-25Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trialLaparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial Crohn's diseaseExperimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab;Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityNULLPending1880BothExperimental group:30;Control group:30;China
236NCT04273399
(ClinicalTrials.gov)
March 20208/1/2020High-impact Exercise in Adults With Crohn's DiseaseFeasibility of High-impact Exercise to Improve Musculoskeletal Outcomes in Adults With Crohn's DiseaseCrohn DiseaseOther: High-impact exercise intervention;Other: Acute response to high-impact exerciseNHS Greater Glasgow and ClydeUniversity of GlasgowNot yet recruiting18 Years40 YearsAll30N/AUnited Kingdom
237EUCTR2019-002895-14-SK
(EUCTR)
26/02/202010/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;Japan;Norway;Germany;Georgia;Bulgaria;Poland;Belgium;Argentina;Hungary;Egypt;United Kingdom;Lithuania;Slovenia;China;South Africa
238NCT03850509
(ClinicalTrials.gov)
February 25, 202015/2/2019Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active InflammationEfficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentCrohn's DiseaseDrug: OPS-2071 150 mg;Drug: OPS-2071 300 mg;Drug: OPS-2071 600 mg;Drug: Matching PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.Iqvia Pty LtdTerminated18 Years70 YearsAll3Phase 2United States;Poland
239EUCTR2018-004614-18-LV
(EUCTR)
19/02/202012/12/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
240EUCTR2019-002895-14-FR
(EUCTR)
17/02/202008/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States
241NCT04254783
(ClinicalTrials.gov)
February 16, 20203/2/2020A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseA Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis (UC);Crohn's DiseaseDrug: Risankizumab;Drug: Cytochrome P450 (CYP) SubstratesAbbVieNULLRecruiting18 Years80 YearsAll20Phase 1United States;Germany;Israel
242NCT04305535
(ClinicalTrials.gov)
February 13, 20205/3/2020Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn DiseaseClinical Trial to Evaluate the Effect of an Oligomeric Oral Nutritional Supplement on the Response in Intestinal Absorption and Inflammation, in Patients With CROHN DiseaseCrohn Disease;Absorption; Disorder, Protein; Disorder; Disorder, Fat; Disorder, Carbohydrate;MalnutritionDietary Supplement: Peptidic+Probiotic;Dietary Supplement: Peptidic+Placebo;Dietary Supplement: Polymeric+PlaceboInstituto de Investigación Sanitaria de la Fundación Jiménez DíazAdventia Pharma, S.L.;Biopolis S.L.Recruiting18 YearsN/AAll162N/ASpain
243EUCTR2019-002895-14-LT
(EUCTR)
13/02/202019/12/2019A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
244NCT04245215
(ClinicalTrials.gov)
February 13, 202023/1/2020Loss of RESponse to Ustekinumab Treated by Dose EscalationLoss of RESponse to Ustekinumab Treated by Dose EscalationCrohn DiseaseDrug: UstekinumabBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZWJanssen Cilag N.V./S.A.Recruiting18 YearsN/AAll108Phase 3Belgium
245NCT04173273
(ClinicalTrials.gov)
February 12, 202020/11/2019A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Etrasimod;Drug: PlaceboArena PharmaceuticalsNULLRecruiting18 Years80 YearsAll1265Phase 2/Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Colombia;Czechia;Denmark;Egypt;France;Georgia;Germany;Greece;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Moldova, Republic of;Netherlands;Philippines;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine
246EUCTR2019-000176-41-IT
(EUCTR)
11/02/202005/11/2020A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment - - Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Product Name: OPS-2071
Product Code: [OPS-2071]
INN or Proposed INN: OPS-2071
Otsuka Pharmaceutical Development and Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Hungary;Canada;Poland;Belgium;Germany;Italy
247ChiCTR2000029543
2020-02-082020-02-03A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's DiseaseA Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease Crohn's DiseaseGold Standard:Histology pathological examination; SES-CD endoscopy score;Index test:ELISA test for multiple serum cytokines;The First Hospital Affiliated to Sun Yat sen UniversityNULLRecruitingBothTarget condition:350;Difficult condition:0China
248NCT03999580
(ClinicalTrials.gov)
February 7, 202024/6/2019The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 )A Pragmatic Randomized Controlled Trial on High Dose Vitamin D to Prevent Relapses of Crohn's Disease in ChildrenCrohn DiseaseDrug: vitamin D3Jantchou PrevostNULLRecruiting4 Years18 YearsAll316Phase 3Canada
249EUCTR2019-001673-93-AT
(EUCTR)
05/02/202013/12/2019A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials.An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials Crohns disease
MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
250NCT03950336
(ClinicalTrials.gov)
February 4, 202013/5/2019Prebiotics and Diet to Reduce Leaky Gut in First Degree Relatives of Crohn's Disease PatientsInfluence of Prebiotics on Intestinal Permeability in First Degree Relatives of Crohn's PatientsHealthy First Degree Relatives of Crohn's Disease PatientsDietary Supplement: Prebiotics;Other: Low n-6 PUFA Diet;Dietary Supplement: Maltodextrin;Other: Control DietUniversity of AlbertaNULLRecruiting15 Years50 YearsAll32N/ACanada
251EUCTR2019-002895-14-HU
(EUCTR)
03/02/202004/02/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Switzerland;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
252EUCTR2019-000852-32-NL
(EUCTR)
30/01/202008/10/2019A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. - The LDN Crohn study Inflammatory Bowel Disease, Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Naltrexone hydrochlorideErasmusMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
122Phase 2Netherlands
253EUCTR2019-000886-19-FR
(EUCTR)
20/01/202026/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TAK-018
INN or Proposed INN: None at this time
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: None at this time
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (a wholly owned subsidiaryNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Germany;United Kingdom
254EUCTR2019-000176-41-PL
(EUCTR)
17/01/202006/09/2019A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing TreatmentA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Product Name: OPS-2071
Product Code: OPS-2071
INN or Proposed INN: OPS-2071
Other descriptive name: OPS-2071
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Belgium;Poland;Germany;Italy
255EUCTR2019-002895-14-IT
(EUCTR)
16/01/202022/01/2021A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease - APD334-202 Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: [APD334]
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: [APD334]
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
ARENA PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Peru;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Lithuania
256EUCTR2019-002895-14-GR
(EUCTR)
14/01/202003/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan
257NCT04225689
(ClinicalTrials.gov)
January 10, 202020/12/2019The Intensive Post Exclusive Enteral Nutrition StudyThe Intensive Post Exclusive Enteral Nutrition Study (iPENS): A Randomised Trial to Evaluate CD-TREAT Diet as a Food Reintroduction Regime in Children and Young Adults With Crohn's DiseaseCrohn DiseaseOther: CD-TREAT dietNHS Greater Glasgow and ClydeUniversity of GlasgowRecruiting6 Years17 YearsAll58N/AUnited Kingdom
258EUCTR2019-002895-14-CZ
(EUCTR)
09/01/202009/01/2020A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's DiseaseA Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine
Arena Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan
259NCT03961815
(ClinicalTrials.gov)
January 6, 20208/5/2019Open-label Extension Study of Brazikumab in Crohn's DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE)Crohn's Disease;IBDDrug: Brazikumab Induction Dose;Drug: Brazikumab Maintenance DoseAstraZenecaNULLEnrolling by invitation18 Years80 YearsAll161Phase 3United States;Austria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Poland;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom
260NCT04233463
(ClinicalTrials.gov)
January 202015/1/2020The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's DiseaseThe Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized StudyCrohn DiseaseDietary Supplement: Modulen;Drug: BudesonideHillel Yaffe Medical CenterNULLNot yet recruiting18 Years70 YearsAll50N/AIsrael
261EUCTR2018-004346-42-ES
(EUCTR)
26/12/201911/11/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden
262NCT03917303
(ClinicalTrials.gov)
December 23, 20195/4/2019Control Crohn Safe TrialControl Crohn Safe With Episodic Adalimumab Monotherapy as First Line Treatment Study.Crohn Disease;Inflammatory Bowel DiseasesDrug: Adalimumab;Drug: standard step-up careMaastricht University Medical CenterMaastricht University;ZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting18 Years70 YearsAll158Phase 4Netherlands
263EUCTR2019-003662-40-DE
(EUCTR)
18/12/201922/10/2019Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen
INN or Proposed INN: ADALIMUMAB
Universitätsklinikum ErlangenNULLNot RecruitingFemale: yes
Male: yes
82Phase 4Germany
264EUCTR2019-003335-37-IT
(EUCTR)
18/12/201917/01/2022A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease.A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants with Moderately to Severely Active Crohn’s Disease: Intervention JNJ-67864238 - PRISM-SCARLET Treatment of moderately to severely active Crohn’s disease with JNJ-67864238.
MedDRA version: 20.0;Level: PT;Classification code 10021425;Term: Immune system disorder;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: JNJ-67864238
Product Code: [JNJ-67864238]
JANSSEN CILAG INTERNATIONAL NVNULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;Argentina;Poland;Russian Federation;Germany;Italy
265EUCTR2018-005086-39-HR
(EUCTR)
16/12/201917/01/2020A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
266EUCTR2019-003816-29-FR
(EUCTR)
16/12/201914/10/2019Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawalFecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal - MIRACLE Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Fecal microbiota
Product Name: Fecal microbiota
ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
267EUCTR2017-001976-48-PT
(EUCTR)
16/12/201922/05/2019A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;United States;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan
268EUCTR2018-004346-42-DE
(EUCTR)
10/12/201917/06/2019A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: MEDI2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
553Phase 2;Phase 3Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of;Canada;Hungary;Czech Republic;France;India;Italy;United Kingdom;Russian Federation;Israel;Austria;Ukraine;Spain;Slovakia;Taiwan;Czechia;United States
269EUCTR2019-000333-39-IT
(EUCTR)
09/12/201924/05/2021Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: [Cx601]
INN or Proposed INN: Darvadstrocel
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose
MILLENNIUM PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany
270EUCTR2017-004294-14-FR
(EUCTR)
02/12/201909/02/2018Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
535 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand;Serbia;Sweden;Romania;Croatia;Brazil;Canada;Mexico;Czech Republic;Turkey;Korea, Republic of;Bosnia and Herzegovina;Moldova, Republic of;Latvia;Denmark;Puerto Rico;France;Italy;Ukraine;Greece;Slovakia;Hong Kong;Taiwan;Portugal;Belarus
271NCT03915262
(ClinicalTrials.gov)
December 2, 20199/4/2019Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's DiseaseExocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological TherapyCrohn DiseaseBiological: Search for exocrine pancreatic insufficiency at week 0 and 12Hospices Civils de LyonNULLRecruiting18 YearsN/AAll50France
272NCT02677350
(ClinicalTrials.gov)
December 1, 20191/2/2016AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE)A Phase I, Pilot Trial to Evaluate the Safety and Efficacy of Injection of Allogeneic Mesenchymal Bone-Marrow Derived Human Stem Cells in Patients With Fistulizing Crohn's Disease.Crohn's Disease;Fistulizing Crohn's Disease;Stem CellsDrug: Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs)Joshua M HareNULLWithdrawn18 YearsN/AAll0Phase 1United States
273NCT04134065
(ClinicalTrials.gov)
December 1, 201917/10/2019the Effect of Vitamin D in Crohn's Diseasethe Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's DiseaseVitamin D Deficiency;Crohn DiseaseDrug: Vitamin D;Drug: Placebo oral capsuleNanjing University School of MedicineShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityNot yet recruiting20 Years60 YearsAll30Early Phase 1NULL
274EUCTR2019-001087-30-AT
(EUCTR)
28/11/201912/09/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Ireland;Chile;Israel;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Ukraine;Spain;Greece;Slovakia;Serbia;Belarus;United States
275EUCTR2017-001240-35-SI
(EUCTR)
27/11/201912/11/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
501Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
276NCT04213729
(ClinicalTrials.gov)
November 26, 201924/12/2019Diet Intervention for Crohn's Disease PatientA Holistic Diet Intervention for People With Crohn's DiseaseCrohn DiseaseBehavioral: Diet Counseling;Other: CD LFD;Behavioral: Dyadic Psychological Support (DPS)University of MiamiThe Leona M. and Harry B. Helmsley Charitable TrustRecruiting18 Years70 YearsAll300N/AUnited States
277EUCTR2019-000886-19-DE
(EUCTR)
26/11/201929/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Takeda Development Center Americas,Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2France;United States;Austria;Netherlands;Germany;United Kingdom
278NCT04164849
(ClinicalTrials.gov)
November 22, 20198/11/2019Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic AcidExtracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic AcidCrohn DiseaseDrug: 5-aminolevulinic acid;Procedure: Blue light photopheresis;Procedure: Transfusion;Procedure: Continuous Mononuclear Cell Collection (CMNC);Procedure: Red light photopheresisUniversity Hospital, AkershusOslo University HospitalRecruiting18 YearsN/AAll10Phase 1/Phase 2Norway
279EUCTR2018-001895-39-HR
(EUCTR)
21/11/201920/01/2020A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
280EUCTR2019-003068-39-NL
(EUCTR)
20/11/201904/11/2019In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Infliximab
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
UMC UtrechtNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Netherlands
281NCT04655729
(ClinicalTrials.gov)
November 18, 201930/11/2020Biomarkers to Predict and Monitor Response to InfliximabDetection of Serum Protein Biomarkers to Predict and Monitor Response to Infliximab Using SOMAscanCrohn DiseaseDrug: InfliximabMassachusetts General HospitalThe Crohn's and Colitis FoundationRecruiting3 Years20 YearsAll120United States
282EUCTR2018-002629-51-AT
(EUCTR)
12/11/201927/06/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
283EUCTR2017-004293-33-FR
(EUCTR)
12/11/201909/02/2018Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden
284ChiCTR1900027370
2019-11-112019-11-10The pathogenic genes and flora of Crohn's disease with anal fistulaThe pathogenic genes and flora of Crohn's disease with anal fistula Crohn's disease with anal fistulaCD anal fistula and CD without anal fistula:N/A;Nanfang Hospital, Southern Medical UniversityNULLRecruitingBothCD anal fistula and CD without anal fistula:50;N/AChina
285EUCTR2019-001087-30-HR
(EUCTR)
11/11/201917/01/2020Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;Japan
286EUCTR2019-000886-19-GB
(EUCTR)
06/11/201929/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence - TAK-018 for Prevention of the Recurrence of Postoperative Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: sibofimloc
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (a wholly owned subsidiaryNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Phase 2United States;France;Austria;Netherlands;Germany;United Kingdom
287EUCTR2017-004292-31-FR
(EUCTR)
05/11/201909/08/2019Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s DiseaseInduction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
675 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan
288EUCTR2018-004346-42-FR
(EUCTR)
05/11/201910/07/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden
289NCT04075825
(ClinicalTrials.gov)
November 4, 201922/8/2019Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II StudyCrohn's Disease;Complex Perianal FistulaBiological: DarvadstrocelMillennium Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll150Phase 3United States;Belgium;Czechia;France;Hungary;Israel;Italy;Poland;Spain
290NCT04154735
(ClinicalTrials.gov)
November 20198/3/2019Autologous Transplant Targeted Against Crohn'sAutologous Hematopoietic Stem Cell Transplant for Crohn's DiseaseCrohn's DiseaseDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: TacrolimusNorthwestern UniversityNULLWithdrawn18 Years49 YearsAll0Phase 2United States
291EUCTR2019-001087-30-DE
(EUCTR)
31/10/201901/07/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
292EUCTR2019-001087-30-BG
(EUCTR)
30/10/201924/10/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Estonia;Slovakia;Portugal;Serbia;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
293EUCTR2018-005086-39-HU
(EUCTR)
28/10/201908/04/2019A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BT-11
INN or Proposed INN: to be requested
Product Code: BT-11
INN or Proposed INN: to be requested
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
294NCT03945019
(ClinicalTrials.gov)
October 28, 20198/5/2019CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's DiseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseBiological: CT-P13 SC (Infliximab);Other: Placebo SCCelltrionNULLActive, not recruiting18 Years75 YearsAll397Phase 3Poland;United States
295NCT03962998
(ClinicalTrials.gov)
October 27, 201922/5/2019A Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects With Active Small Bowel Crohn's DiseaseA Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects With Active Small Bowel Crohn's DiseaseCrohn DiseaseDrug: Lactulose/Rhamnose solution;Drug: MB-102MediBeaconNULLRecruiting18 YearsN/AAll20Early Phase 1United States
296EUCTR2019-002093-32-SE
(EUCTR)
24/10/201928/06/2019A randomised, open, within-patient controlled trial to evaluate the diagnostic usefulness of Computed Tomography with the new contrast agent Lumentin® 44 as compared to Magnetic Resonance Imaging in patients with small bowel Crohn’s disease.Randomised, open, non-inferiority within patient-controlled trial evaluating the diagnostic usefulness of Lumentin® 44 when used as contrast agent in CT-enterography as compared to MRI- enterography in patients with small bowel Crohn’s disease. None.Lumentin 44 is a contrast agent. The diagnostic usefulness of CT with Lumentin 44 as contrast agent as compared to MRE will be investigated in this trial.Patients with confirmed small bowel Crohn's disease referred to MRE examination will be included in the trial. Neither their medical condition nor disease will be investigated.
MedDRA version: 22.1;Level: LLT;Classification code 10011603;Term: CT scan;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: Lumentin 44
Product Code: L 44
INN or Proposed INN: Egg Albumen Powder
Other descriptive name: EGG WHITE PROTEIN
Trade Name: Movprep
Lument ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Sweden
297EUCTR2018-004614-18-NL
(EUCTR)
21/10/201927/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
298NCT04131504
(ClinicalTrials.gov)
October 16, 201916/10/2019Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNFCrohn's Disease;IBDDrug: Infliximab;Drug: AdalimumabChildren's Hospital Medical Center, CincinnatiThe Leona M. and Harry B. Helmsley Charitable TrustActive, not recruiting1 Year22 YearsAll239United States
299EUCTR2018-004614-18-DE
(EUCTR)
15/10/201925/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
300EUCTR2019-000333-39-CZ
(EUCTR)
15/10/201903/09/2019Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal FistulaA Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Cx601
Product Code: Cx601
INN or Proposed INN: DARVADSTROCEL
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
Millennium Pharmaceuticals, Inc (MPI)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
301NCT03914261
(ClinicalTrials.gov)
October 15, 201911/4/2019Expanded Access to RisankizumabExpanded Access to RisankizumabCrohn's Disease;Ulcerative Colitis (UC)Drug: RisankizumabAbbVieNULLAvailable18 YearsN/AAllBelgium;Israel;Spain;Switzerland;United States
302NCT04131322
(ClinicalTrials.gov)
October 10, 201910/10/2019Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH StudyCrohn Disease;Ulcerative ColitisDrug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for InjectionFundación Pública Andaluza para la gestión de la Investigación en SevillaNULLTerminated18 YearsN/AAll24Phase 4Spain
303EUCTR2018-004614-18-IT
(EUCTR)
09/10/201930/07/2021Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: Mirikizumab
Trade Name: STELARA 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
Product Name: MIRIKIZUMAB
Product Code: [
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
304EUCTR2017-004295-55-FR
(EUCTR)
08/10/201909/02/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;New Zealand;Japan;Norway;Germany;Georgia;Bulgaria;Singapore;Poland;Belgium;Argentina;Hungary;United Kingdom;Austria;Lithuania;Finland;Slovenia;China;Netherlands;South Africa;Australia;Switzerland;Russian Federation
305EUCTR2018-005086-39-PL
(EUCTR)
07/10/201906/05/2019A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative ColitisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Landos Biopharma Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
306JPRN-jRCT1031190056
30/09/201917/07/2019E6011-CS1 studyResearch for medicinal predictive marker on Crohn's disease - E6011-CS1 study Crohn's disease
Crohn's disease;D003424
Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit.

1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination
2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination
3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination

Study2:None.
Mikami YoheiEA Pharma Co.,Ltd.(Utilize AMED's funds)Not Recruiting>= 16age oldNot applicableBoth32N/AJapan
307EUCTR2018-001895-39-NL
(EUCTR)
27/09/201903/06/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany
308EUCTR2018-002629-51-IT
(EUCTR)
26/09/201915/06/2021A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA - 90 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 1.0 ML (90 MG/ML) 1 FLACONCINO
Product Name: Ustekinumab
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
Other descriptive name: ustekinumab
Trade Name: STELARA - 45 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 0.5 ML (90 MG/ML) 1 FLACONCINO
Product Name: USTEKINUMAB
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
309NCT04102111
(ClinicalTrials.gov)
September 23, 201923/9/2019A Study Evaluating Participants With Moderately to Severely Active Crohn's DiseaseA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-67864238;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 Years75 YearsAll90Phase 2United States;Argentina;Germany;Italy;Poland;Russian Federation;Ukraine;France
310NCT03847467
(ClinicalTrials.gov)
September 20, 201912/2/2019Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF TherapyPilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF TherapyInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisDrug: 2'-Fucosyllactose;Other: PlaceboChildren's Hospital Medical Center, CincinnatiBroad Institute;University of Cincinnati;Connecticut Children's Medical CenterRecruiting11 Years25 YearsAll216Phase 1/Phase 2United States
311ChiCTR1900026091
2019-09-192019-09-20Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's diseaseDevelopment of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study Crohn's diseaseCase series:infliximab;The First Affiliated Hospital of Sun Yat-sen UniversityNULLPending958BothCase series:343;China
312NCT03718182
(ClinicalTrials.gov)
September 17, 201923/10/2018Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy?Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled TrialCrohn Disease;Vitamin D DeficiencyDietary Supplement: CholecalciferolUniversity Hospital Birmingham NHS Foundation TrustNational Institute for Health Research, United Kingdom;University of Birmingham;Clinical Trials Research CentreRecruiting18 YearsN/AAll50Phase 4United Kingdom
313EUCTR2018-004614-18-GB
(EUCTR)
16/09/201920/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Russian Federation;United States;Serbia;Taiwan;Spain;Ukraine;Israel;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden;India;Slovakia
314EUCTR2018-004614-18-ES
(EUCTR)
12/09/201904/07/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
315EUCTR2018-004614-18-FR
(EUCTR)
11/09/201920/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
316EUCTR2017-004588-11-NL
(EUCTR)
10/09/201910/09/2019Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment.Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease. - CoCroS trial The chronic inflammatory bowel disease Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: HumiraUniversity MaastrichtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
158Phase 4Netherlands
317EUCTR2018-004346-42-GB
(EUCTR)
10/09/201930/05/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden
318EUCTR2019-001087-30-IT
(EUCTR)
10/09/201917/01/2022Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease - / Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Inflectra
Product Name: /
Product Code: [CT-P13]
INN or Proposed INN: INFLIXIMAB
Trade Name: Remisma
Product Name: 00000
Product Code: [CT-P13]
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: INFLIXIMAB
CELLTRION INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan
319NCT03885713
(ClinicalTrials.gov)
September 10, 20194/3/2019Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel DiseaseIdentification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry ApproachesInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisBiological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumabFundación de Investigación Biomédica - Hospital Universitario de La PrincesaNULLRecruiting18 YearsN/AAll180Phase 4Spain
320EUCTR2019-001087-30-PL
(EUCTR)
09/09/201924/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
321EUCTR2018-001895-39-BG
(EUCTR)
05/09/201916/07/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
322EUCTR2018-004614-18-PL
(EUCTR)
03/09/201909/07/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany;Japan;Sweden
323EUCTR2019-001948-21-FR
(EUCTR)
03/09/201915/05/2019Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas.Double-blind randomised placebo controlled study evaluating local co-administration of autologous ADIpose derived stromal vascular fraction with microfat for refractory perianal CROHN’s fistulas. - ADICROHN-II Crohn’s disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: autologous ADIpose derived stromal vascular fraction
Product Code: ADSVF
Trade Name: vialebex 200mg
Product Name: VIALEBEX
Product Code: SERUM ALBUMINE 5%
INN or Proposed INN: ALBUMINE HUMAINE
Other descriptive name: HUMAN ALBUMIN AS MACROAGGREGATES
Trade Name: serum physiologique 0.9 %
Product Name: chlorure de sodium
INN or Proposed INN: CHLORURE DE SODIUM
Other descriptive name: SODIUM CHLORIDE
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2France
324EUCTR2019-001087-30-GR
(EUCTR)
28/08/201926/07/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
325EUCTR2019-001087-30-ES
(EUCTR)
14/08/201910/09/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
326EUCTR2019-001087-30-FR
(EUCTR)
13/08/201914/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
327EUCTR2018-002109-70-CZ
(EUCTR)
12/08/201927/12/2018A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel diseaseEarly phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable Active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: E6011
INN or Proposed INN: Undetermined
Other descriptive name: IGG2 ANTIBODIES
EA Pharma Co., Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Czechia;Hungary;Czech Republic;Poland;Russian Federation;Japan
328EUCTR2019-001087-30-HU
(EUCTR)
09/08/201910/08/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
329EUCTR2019-001087-30-CZ
(EUCTR)
06/08/201906/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: REMSINA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Romania;Croatia;Bulgaria;Germany;Japan
330EUCTR2018-002629-51-FR
(EUCTR)
31/07/201924/04/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Spain;Netherlands;Germany;Sweden
331EUCTR2019-001087-30-LV
(EUCTR)
25/07/201904/06/2019Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's diseaseA Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Celltrion, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
332EUCTR2018-004614-18-HU
(EUCTR)
25/07/201911/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
333NCT03926130
(ClinicalTrials.gov)
July 23, 201923/4/2019A Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Mirikizumab;Drug: Ustekinumab;Drug: PlaceboEli Lilly and CompanyNULLRecruiting15 Years80 YearsAll1150Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Sweden
334EUCTR2016-003191-50-FR
(EUCTR)
17/07/201928/01/2019A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
959Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
335EUCTR2017-000725-12-DE
(EUCTR)
17/07/201928/02/2019A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy
336NCT04018599
(ClinicalTrials.gov)
July 15, 201911/7/2019Comparison of PK and Tolerability of MSB11022 Administered by AI or PFSA Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy SubjectsRheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious UveitisDrug: 40 mg MSB11022Fresenius Kabi SwissBioSim GmbHPRA Health SciencesCompleted18 Years55 YearsAll216Phase 1United States
337EUCTR2017-001226-18-SI
(EUCTR)
15/07/201906/03/2019A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
645Phase 3United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden;Portugal
338EUCTR2018-004614-18-AT
(EUCTR)
10/07/201928/05/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
339NCT04056442
(ClinicalTrials.gov)
July 7, 201913/8/2019A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease PatientsA Phase 2a, Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease PatientsSteroid Dependent Crohn's DiseaseDrug: Cannabidiol , synthetic form;Drug: PlaceboStero Biotechs Ltd.NULLRecruiting18 YearsN/AAll28Phase 2Israel
340ChiCTR1900023696
2019-07-012019-06-08Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trialEndoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial Chron's diseaseGroup 1:EBD;Group 2:EBD combined with local injection of betamethasone;The Sixth Affiliated Hospital of Sun Yat-sen UniversityNULLPending1875BothGroup 1:45;Group 2:45;N/AChina
341JPRN-JapicCTI-194830
01/7/201927/06/2019Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease] Crohn's diseaseIntervention name : Vedolizumab (Genetical Recombination)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Vedolizumab (Genetical Recombination) 300 milligrams (mg), intravenous (IV) infusion, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Takeda Pharmaceutical Company LimitedNULLpendingBOTH300NAJapan
342NCT04002180
(ClinicalTrials.gov)
July 1, 201926/6/2019Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease]Crohn's DiseaseDrug: Vedolizumab (Genetical Recombination)TakedaNULLRecruitingN/AN/AAll300Japan
343NCT04089514
(ClinicalTrials.gov)
June 30, 201912/9/2019A Real-world Study of Imraldi® UsePan-EU Real-World Experience With Imraldi®Arthritis, Rheumatoid (RA);Axial Spondyloarthritis (axSpA);Arthritis, Psoriatic (PsA);Crohn's Disease (CD);Colitis, Ulcerative (UC)Drug: AdalimumabBiogenNULLCompleted18 YearsN/AAll1000Belgium;Germany;Ireland;Italy;Spain;United Kingdom
344NCT03656627
(ClinicalTrials.gov)
June 27, 201931/8/2018Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseSafety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune DiseaseAutoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative ColitisDrug: NivolumabAlliance Foundation Trials, LLC.Bristol-Myers SquibbActive, not recruiting18 YearsN/AAll7Phase 1United States
345EUCTR2019-002038-35-BE
(EUCTR)
27/06/201907/06/2019A study meausring ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patientsA prospective study investigating ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients - DUST Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Stelara
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
UZ LeuvenNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Belgium
346EUCTR2019-000717-37-ES
(EUCTR)
27/06/201928/06/2019Loss of response of the Adalimumba biosimilar compared with the original drugLOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.ADA-SWITCH Study - ADA-SWITCH Study Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: AMGEVITA®
Product Name: AMGEVITA (Adalimumab biosimilar )
Trade Name: HUMIRA ®
Product Name: Humira (adalimumab original)
Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)NULLNot RecruitingFemale: yes
Male: yes
136Phase 4Spain
347EUCTR2017-004997-32-DE
(EUCTR)
25/06/201914/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes
320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany
348NCT04254549
(ClinicalTrials.gov)
June 14, 20193/2/2020Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.Crohn Disease;Diabetic GastroparesisDrug: Rifaximin;Drug: PlaceboMayo ClinicNULLRecruiting18 Years75 YearsAll40Phase 2United States
349EUCTR2018-001895-39-CZ
(EUCTR)
06/06/201905/03/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 2United States;Serbia;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
350EUCTR2017-002195-13-GB
(EUCTR)
05/06/201928/02/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
351NCT03941418
(ClinicalTrials.gov)
June 1, 20195/5/2019Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn DiseaseImpact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn DiseaseUlcerative Colitis;Crohn DiseaseDietary Supplement: Boulardii;Dietary Supplement: PlaceboUniversity Clinic Dr Dragisa Misovic-DedinjeUniversity Clinic ZvezdaraNot yet recruiting18 Years80 YearsAll150N/ANULL
352NCT03798691
(ClinicalTrials.gov)
May 28, 20192/1/2019Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With VedolizumabA Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With VedolizumabInflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Herpes ZosterBiological: ShingrixUniversity of Wisconsin, MadisonBoston Medical CenterRecruiting50 Years70 YearsAll30Phase 4United States
353NCT03559660
(ClinicalTrials.gov)
May 20, 20195/6/2018CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)Crohn's DiseaseDrug: Certolizumab PegolUCB Biopharma S.P.R.L.NULLAvailable18 YearsN/AAllNULL
354NCT03677648
(ClinicalTrials.gov)
May 14, 201917/9/2018A Phase II Study in Patients With Moderate to Severe Active Crohn's DiseaseA Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's DiseaseCrohn's DiseaseDrug: SHR0302;Drug: PlacebosReistone Biopharma Company LimitedNULLActive, not recruiting18 Years75 YearsAll144Phase 2United States;China;Poland;Ukraine
355EUCTR2017-003090-34-HU
(EUCTR)
10/05/201925/03/2019A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
28 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Belgium;Austria;Netherlands;Germany
356EUCTR2016-003190-17-FR
(EUCTR)
07/05/201914/03/2019A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
357ChiCTR1900022728
2019-05-012019-04-23Cohort study combined with omics screening for the early diagnostic markers in Crohn's diseaseCohort study combined with omics screening for the early diagnostic markers in Crohn's disease Crohn's diseaseGold Standard:Clinical outcome;Index test:Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD;The 7th Medical Center of the PLA General Hospital (Army general hospital)NULLPendingBothTarget condition:310;Difficult condition:160China
358NCT03808103
(ClinicalTrials.gov)
May 1, 20194/1/2019Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's DiseaseA Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients With Inactive Crohn's Disease (CD)Crohn DiseaseBiological: Placebo;Biological: Bacteriophage preparationIntralytix, Inc.MOUNT SINAI HOSPITALRecruiting18 YearsN/AAll30Phase 1/Phase 2United States
359EUCTR2018-004967-30-GB
(EUCTR)
30/04/201914/01/2019Inflammatory Bowel Disease (IBD) Reference product (Humira-adalimumab) and Biosimilar Product (Imraldi-adalimumab) CroSS over StudyIBD Reference and Biosimilar adalimumab CroSS over Study - iBaSS Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Imraldi
Product Name: Imraldi
INN or Proposed INN: adalimumab
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: adalimumab
University Hospital Southampton NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United Kingdom
360EUCTR2018-003594-95-NL
(EUCTR)
30/04/201930/04/2019Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapyMethotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response Inflammatory bowel disease: Crohn's disease and Ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: methotrexate injection
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Amsterdam UMC location AMCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
361NCT03733314
(ClinicalTrials.gov)
April 25, 20195/11/2018A Study of E6011 in Participants With Active Crohn's DiseaseEarly Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: E6011;Drug: PlaceboEA Pharma Co., Ltd.NULLRecruiting18 Years64 YearsAll40Phase 2Czechia;Hungary;Japan;Poland;Russian Federation
362EUCTR2018-002629-51-SE
(EUCTR)
23/04/201929/01/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Czechia;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Germany;Netherlands;Sweden;Korea, Republic of
363EUCTR2017-001225-41-SI
(EUCTR)
19/04/201906/03/2019A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
738Phase 3Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
364EUCTR2017-000725-12-GB
(EUCTR)
17/04/201922/10/2018A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD).A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. Perianal fistulising Crohn´s disease
MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Alofisel
Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601
Product Code: Cx601
INN or Proposed INN: nap
Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
TiGenix, S.A.U.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
554Phase 3United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom
365EUCTR2017-003090-34-NL
(EUCTR)
16/04/201919/12/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of
366EUCTR2018-002109-70-HU
(EUCTR)
15/04/201920/11/2018A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel diseaseEarly phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable Active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: E6011
INN or Proposed INN: Undetermined
Other descriptive name: IGG2 ANTIBODIES
EA Pharma Co., Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Hungary;Poland;Japan
367EUCTR2018-002064-15-NL
(EUCTR)
15/04/201915/04/2019Patient preference model: treatment of perianal fistulas in Crohn's diseaseTreatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
Product Name: Infliximab
Trade Name: Humira
Product Name: Adalimumab
Academic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
140Phase 4Netherlands
368EUCTR2017-001976-48-DK
(EUCTR)
15/04/201929/01/2019A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Bouvet Island;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
369NCT03942120
(ClinicalTrials.gov)
April 8, 20197/5/2019Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARACrohn DiseaseDrug: UstekinumabJanssen Korea, Ltd., KoreaNULLRecruiting18 YearsN/AAll70Korea, Republic of
370EUCTR2018-001272-37-HR
(EUCTR)
05/04/201917/05/2019A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
371NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll312Phase 1United States;Canada
372EUCTR2017-002195-13-PT
(EUCTR)
18/03/201923/07/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Serbia;United States;Portugal;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
373NCT03884439
(ClinicalTrials.gov)
March 18, 20194/3/2019Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)Crohn's Disease;Ulcerative ColitisDrug: Infliximab [infliximab biosimilar 3]PfizerNULLRecruitingN/AN/AAll300Japan
374EUCTR2018-003303-19-PL
(EUCTR)
15/03/201923/01/2019A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease.A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease. Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SHR0302
INN or Proposed INN: Pending
Reistone Biopharma Company LimitedNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Poland;Ukraine;China
375EUCTR2017-001225-41-IE
(EUCTR)
08/03/201913/03/2018A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
747Phase 3Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
376EUCTR2017-001226-18-IE
(EUCTR)
08/03/201905/03/2018A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
645Phase 3Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
377EUCTR2017-001240-35-IE
(EUCTR)
08/03/201905/03/2018A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
501Phase 3Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
378JPRN-JapicCTI-184145
06/3/201910/10/2018Phase 3 Study of Cx601 in Subjects with Complex Perianal Fistulising Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients with Crohn's Disease Complex perianal fistulas in adult patients with Crohn's diseaseIntervention name : Darvadstrocel
INN of the intervention : Darvadstrocel
Dosage And administration of the intervention : Darvadstrocel (Cx601) of cell suspension 24 milliliters (mL), intralesional injection, once dose on Day 1.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Takeda Pharmaceutical Company LimitedNULLcomplete18BOTH22Phase 3Japan
379NCT03706456
(ClinicalTrials.gov)
March 6, 201911/10/2018Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's DiseaseComplex Perianal Fistulas in Adult Patients With Crohn's DiseaseBiological: DarvadstrocelTakedaNULLActive, not recruiting18 YearsN/AAll22Phase 3Japan
380NCT03901937
(ClinicalTrials.gov)
March 1, 201912/3/2019The Effects of Parenteral ?-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's DiseaseDepartment of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, ChinaCrohn DiseaseDrug: ?-3 polyunsaturated fatty acid;Procedure: Intestinal surgery for Crohn's DiseaseSir Run Run Shaw HospitalNULLRecruiting18 Years75 YearsAll158Phase 4China
381EUCTR2017-000617-23-GB
(EUCTR)
28/02/201911/04/2018Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
983 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
382EUCTR2017-000575-88-GB
(EUCTR)
28/02/201911/04/2018 Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1032 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
383EUCTR2017-000617-23-GR
(EUCTR)
26/02/201921/02/2019Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
384EUCTR2017-000576-29-GR
(EUCTR)
26/02/201925/02/2019Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 Crohn’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
385EUCTR2017-000574-11-GR
(EUCTR)
26/02/201927/11/2017Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA Ulcerative colitis or Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
2453Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
386EUCTR2018-001272-37-PT
(EUCTR)
25/02/201930/07/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
387EUCTR2018-001272-37-AT
(EUCTR)
25/02/201921/09/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of
388NCT03681067
(ClinicalTrials.gov)
February 20, 201920/8/2018A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's DiseaseA Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients With Moderate-to-Severe Crohn's DiseaseCrohn DiseaseDrug: GSK1070806;Drug: Placebo- sodium chlorideUniversity of BirminghamGlaxoSmithKline;University Hospital BirminghamCompleted16 YearsN/AAll5Phase 1/Phase 2United Kingdom
389EUCTR2017-003090-34-DE
(EUCTR)
18/02/201915/11/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BI 655130
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Denmark;Austria
390EUCTR2016-005199-90-SK
(EUCTR)
14/02/201914/02/2018Open Label Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn’s Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study - RHB-104-04 and MAP (US2) Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Canada;Poland;Australia;Israel;New Zealand
391EUCTR2017-000575-88-IT
(EUCTR)
11/02/201922/01/2021Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: [SHP647]
INN or Proposed INN: Anti-MadCam Antibody
Product Name: SHP647
Product Code: [SHP647]
INN or Proposed INN: Anti-MAdCAM antibody
SHIRE HUMAN GENETIC THERAPIES, INCNULLNot RecruitingFemale: yes
Male: yes
1032Phase 3Serbia;United States;Czechia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand
392NCT03681652
(ClinicalTrials.gov)
February 11, 201920/9/2018Post-Operative Crohn's Disease Outcome in ChildrenPost-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open StudyCrohn DiseaseDrug: Azathioprine;Drug: Anti-TNF DrugSchneider Children's Medical Center, IsraelNULLRecruiting6 Years18 YearsAll100Israel
393EUCTR2017-000617-23-IT
(EUCTR)
11/02/201922/01/2021Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: [SHP647]
INN or Proposed INN: Anti-MAdCAM antibody
Product Name: SHP647
Product Code: [SHP647]
INN or Proposed INN: Anti-MAdCAM antibody
SHIRE HUMAN GENETIC THERAPIES, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
983Phase 3Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Portugal;Serbia;United States
394NCT03627091
(ClinicalTrials.gov)
February 6, 201924/7/2018Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)Crohn's DiseaseDrug: Ontamalimab;Other: PlaceboShireNULLCompleted16 Years80 YearsAll40Phase 3United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Croatia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom
395EUCTR2017-003090-34-AT
(EUCTR)
05/02/201911/10/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD Fistulizing Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim RCV GmbH & Co KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
396NCT03752970
(ClinicalTrials.gov)
February 5, 201922/11/2018A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's DiseaseMechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's DiseaseCrohn DiseaseDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLActive, not recruiting18 Years75 YearsAll27Phase 2Austria;Belgium;Denmark;Germany;Hungary;Korea, Republic of;Netherlands;Spain
397EUCTR2017-004295-55-PT
(EUCTR)
04/02/201901/10/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
398EUCTR2017-004997-32-HU
(EUCTR)
04/02/201904/04/2019A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
320 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
399NCT03850600
(ClinicalTrials.gov)
January 30, 201915/2/2019Modulating Early Life Microbiome Through Dietary Intervention in Crohn's DiseaseThe MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's DiseaseCrohn Disease;PregnancyOther: Diet-CDIcahn School of Medicine at Mount SinaiThe Leona M. and Harry B. Helmsley Charitable Trust;University of Massachusetts, WorcesterRecruiting18 YearsN/AFemale396N/AUnited States
400EUCTR2017-004997-32-NL
(EUCTR)
30/01/201906/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLNot RecruitingFemale: yes
Male: yes
320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
401EUCTR2016-000634-21-FR
(EUCTR)
28/01/201908/11/2018A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
693Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
402NCT03650413
(ClinicalTrials.gov)
January 14, 201916/8/2018An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: UTTR1147AGenentech, Inc.NULLActive, not recruiting18 Years80 YearsAll143Phase 2United States;Bulgaria;Georgia;Germany;Greece;Ireland;Italy;Moldova, Republic of;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France;Hungary;Israel;Netherlands
403EUCTR2017-000575-88-HR
(EUCTR)
11/01/201916/05/2019Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
1032Phase 3New Zealand;Japan;Netherlands;Germany;South Africa;Australia;Croatia;Romania;Poland;Brazil;Czech Republic;Italy;United Kingdom;Israel;Russian Federation;Austria;Lithuania;Czechia;Serbia;United States
404EUCTR2017-000617-23-HR
(EUCTR)
11/01/201916/05/2019Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Name: SHP647
Product Code: SHP647
INN or Proposed INN: ontamalimab
Shire Human Genetic Therapies, Inc.NULLNot RecruitingFemale: yes
Male: yes
983Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
405EUCTR2018-001272-37-FR
(EUCTR)
10/01/201923/07/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseA Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease Moderately-to-Severely Active Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not Assigned
Other descriptive name: THRX-139060
Theravance Biopharma Ireland LimitedNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Serbia;Portugal;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany
406EUCTR2017-004997-32-IT
(EUCTR)
10/01/201918/06/2021Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE - NA Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
Product Code: [NA]
GENENTECH, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
407EUCTR2018-002629-51-NL
(EUCTR)
08/01/201912/11/2018A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
408EUCTR2017-004997-32-GB
(EUCTR)
04/01/201909/10/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Germany;Netherlands;Bulgaria;Poland;Hungary;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;Greece;Serbia;United States
409NCT03773237
(ClinicalTrials.gov)
December 31, 201812/11/2018Intralipid Versus SMOFlipid in HPN PatientsRandomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.Short Bowel Syndrome;Intestinal Fistula;Crohn Disease;Intestinal ObstructionDietary Supplement: SMOFLipid;Dietary Supplement: IntralipidMayo ClinicNULLRecruiting18 Years75 YearsAll100N/AUnited States
410EUCTR2017-001225-41-HR
(EUCTR)
31/12/201821/05/2019A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
747 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
411EUCTR2018-002925-47-ES
(EUCTR)
28/12/201816/11/2018prediction of response to therapy in inflammatory bowel diseaseIdentification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches Inflammatory bowel disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Vedolizumab
INN or Proposed INN: VEDOLIZUMAB
Other descriptive name: VEDOLIZUMAB
Fundación de Investigación Biomédica del Hospital Universitario de La PrincesaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
412NCT03782376
(ClinicalTrials.gov)
December 20, 201811/12/2018A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ustekinumab approximately 6 mg/kg (IV);Drug: Placebo (SC);Drug: Placebo (IV);Drug: Ustekinumab 90 mg (SC) Group 1;Drug: Ustekinumab 90 mg (SC) Group 2Janssen-Cilag Ltd.NULLRecruiting18 YearsN/AAll200Phase 3United States;Austria;Czechia;France;Germany;Italy;Korea, Republic of;Netherlands;Russian Federation;Spain;Sweden;United Kingdom
413EUCTR2017-001976-48-DE
(EUCTR)
20/12/201822/08/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Czechia;Taiwan;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
414EUCTR2017-001240-35-HR
(EUCTR)
20/12/201821/05/2019A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic TherapiesA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
501Phase 3Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
415JPRN-jRCT1051190043
20/12/201802/09/2019Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosisSafety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707 Crohn's diseaseAt the time of resumption of food after endoscopic balloon dilation, patients receive 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.Takehara TetsuoIijima HidekiRecruiting20ageNot applicableBoth15Phase 2Japan
416EUCTR2017-001976-48-IT
(EUCTR)
20/12/201828/01/2021A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: [BMS-986165]
Other descriptive name: BMS986165
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Romania;Australia;Denmark;Germany;Korea, Republic of
417EUCTR2017-001226-18-HR
(EUCTR)
19/12/201821/05/2019A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy Crohn's Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
645 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
418ChiCTR1800019958
2018-12-162018-12-09Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's DiseaseCombining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease Crohn's diseaseCase series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy;Daping Hospital, Army Medical University (Third Military Medical University)NULLRecruiting1865BothCase series:60;China
419EUCTR2017-004997-32-IE
(EUCTR)
14/12/201813/12/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: efmarodocokin alfa
INN or Proposed INN: efmarodocokin alfa
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany
420EUCTR2017-004295-55-BE
(EUCTR)
13/12/201830/03/2018Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Product Name: ozanimod
Product Code: RPC1063 (equivalent to ozanimod HCl)
INN or Proposed INN: Ozanimod
Other descriptive name: OZANIMOD
Celgene International II SàrlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand
421EUCTR2018-002001-65-GB
(EUCTR)
13/12/201801/10/2018A clinical trial of antibody GSK1070806 in the treatment of patients with moderate to severe Crohn’s DiseaseA Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease - CDAID GSK1070806 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK1070806
INN or Proposed INN: GSK1070806
Other descriptive name: fully humanised, recombinant monoclonal antibody (IgG1)
University of BirminghamNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
36 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
422EUCTR2018-002629-51-ES
(EUCTR)
12/12/201816/11/2018A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Spain;Netherlands;Germany;Sweden
423EUCTR2017-004997-32-ES
(EUCTR)
10/12/201817/09/2018A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE Ulcerative Colitis (UC) or Crohn's Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Roche Farma, S.A por delegación de Genentech, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
320 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
424NCT03759288
(ClinicalTrials.gov)
December 7, 201820/11/2018An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)Crohn's Disease;IBDDrug: Brazikumab low dose;Drug: Brazikumab high dose;Drug: Humira®;Drug: PlaceboAstraZenecaNULLRecruiting18 Years80 YearsAll928Phase 2/Phase 3United States;Australia;Austria;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Romania
425NCT03574948
(ClinicalTrials.gov)
December 6, 201822/6/20185-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue ScoresMulticentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue ScoresCrohn Disease;Ulcerative Colitis;Fatigue;RemissionDrug: 5-HTP;Drug: Placebo oral capsuleUniversity Hospital, GhentNULLCompleted18 Years60 YearsAll175Phase 2Belgium
426EUCTR2018-001272-37-DE
(EUCTR)
04/12/201826/07/2018A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease