96. クローン病
[臨床試験数:2,209,薬物数:1,276(DrugBank:240),標的遺伝子数:166,標的パスウェイ数:210

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
34 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002674-26-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
2NCT04646187
(ClinicalTrials.gov)
December 202020/11/2020De-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 AGNot yet recruiting12 Years25 YearsAll148Phase 4Belgium;Netherlands;Spain
3EUCTR2020-002674-26-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 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
4EUCTR2020-002674-26-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
5EUCTR2020-001811-26-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04524611
(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 YearsAll517Phase 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
7NCT03847467
(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
8EUCTR2018-003594-95-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]
Amsterdam UMC location AMCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 4Netherlands
9NCT03090139
(ClinicalTrials.gov)
March 28, 201722/3/2017Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging MarketsIndicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE)Colitis, Ulcerative;Crohn Disease;Inflammatory Bowel DiseasesDrug: Anti-TNF TherapyTakedaNULLCompleted18 YearsN/AAll1731Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey
10NCT02772965
(ClinicalTrials.gov)
October 201627/4/2016Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) TherapyA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF TherapyPediatric Crohn's DiseaseDrug: Methotrexate;Other: Sugar pill (placebo)University of North Carolina, Chapel HillPatient-Centered Outcomes Research Institute;ImproveCareNow (ICN);The Leona M. and Harry B. Helmsley Charitable Trust;Children's Hospital Medical Center, Cincinnati;Grifols Diagnostics Solutions, Inc;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingN/A20 YearsAll425Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02793778
(ClinicalTrials.gov)
July 20161/6/2016Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF TherapyA Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects With Crohn's Disease (CD) Receiving Anti-TNF TherapyCrohn's DiseaseDrug: CROWN;Drug: CROWN PlaceboPrometheus LaboratoriesNestlé Health Science Spain;Nestec Ltd.Terminated18 Years85 YearsAll42Phase 2United States
12EUCTR2014-003240-12-NL
(EUCTR)
27/11/201521/04/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. 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: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
13EUCTR2014-003240-12-NO
(EUCTR)
19/10/201508/04/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden
14EUCTR2014-003240-12-PL
(EUCTR)
21/08/201509/06/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators orAnti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
15EUCTR2014-003240-12-IT
(EUCTR)
16/07/201528/02/2018A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. - n/a 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]
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLNot Recruiting Female: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2014-003240-12-ES
(EUCTR)
24/06/201527/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
17EUCTR2014-003240-12-SK
(EUCTR)
22/06/201509/04/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
18EUCTR2014-003240-12-DE
(EUCTR)
22/06/201525/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
19EUCTR2014-003240-12-BE
(EUCTR)
19/06/201518/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
20EUCTR2014-003240-12-DK
(EUCTR)
10/06/201531/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Denmark;Australia;Norway;Netherlands;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-003240-12-HU
(EUCTR)
11/05/201525/03/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
22EUCTR2014-003240-12-CZ
(EUCTR)
04/05/201507/05/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT- 494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy Crohn's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABT 494 3mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
Product Name: ABT 494 12mg
INN or Proposed INN: Not applicable
Other descriptive name: A-1293543.74
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
23NCT02365649
(ClinicalTrials.gov)
March 17, 201516/2/2015A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF TherapyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF TherapyCrohn's DiseaseDrug: ABT-494;Drug: PlaceboAbbVieNULLCompleted18 Years75 YearsAll219Phase 2United States;Australia;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Romania;Slovakia;Spain;United Kingdom;Czech Republic;Sweden
24EUCTR2013-002902-29-NL
(EUCTR)
12/02/201525/02/2014Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: BI 655066 10 mg/ml
Product Code: BI 655066 10 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Product Name: BI 655066 90 mg/ml
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: not available yet
Other descriptive name: BI 655066
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of
25EUCTR2013-002902-29-DE
(EUCTR)
22/12/201408/08/2014Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease
MedDRA version: 19.1;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: Risankizumab 10 mg/ml
INN or Proposed INN: Risankizumab
Product Code: Risankizumab 90 mg/ml
INN or Proposed INN: Risankizumab
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2013-002902-29-IE
(EUCTR)
03/02/201428/11/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer Ingelheim LimitedNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
27NCT02031276
(ClinicalTrials.gov)
February 201416/12/2013Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF TherapyCrohn DiseaseDrug: risankizumab IV;Drug: risankizumab SC;Drug: PlaceboAbbVieBoehringer IngelheimCompleted18 Years75 YearsAll121Phase 2Belgium;Canada;France;Germany;Ireland;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom;United States
28EUCTR2013-002902-29-ES
(EUCTR)
09/01/201405/12/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of
29EUCTR2013-002902-29-BE
(EUCTR)
09/01/201420/09/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
Other descriptive name: BI 655066
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
30EUCTR2013-002902-29-GB
(EUCTR)
10/12/201326/11/2013Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: BI 655066 10 mg/ml
Other descriptive name: BI 655066
Product Code: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer Ingelheim LimitedNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT01287897
(ClinicalTrials.gov)
February 201131/1/2011A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF TherapyA Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)Crohn's DiseaseDrug: PF-04236921 SC injectionPfizerNULLCompleted18 Years75 YearsAll250Phase 2United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;New Zealand;Romania;Switzerland;United Kingdom;Sweden
32NCT02322008
(ClinicalTrials.gov)
September 200917/12/2014Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical PracticeAnti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical PracticeCrohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseBiological: infliximab and adalimumabRegionshospitalet Viborg, SkiveNULLCompleted18 YearsN/ABoth1035N/ANULL
33NCT00771667
(ClinicalTrials.gov)
December 200810/10/2008A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF TherapyA Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist TherapyCrohn's DiseaseDrug: Placebo (IP);Drug: Ustekinumab 1mg/kg (IP);Drug: Ustekinumab 3 mg/kg (IP);Drug: Ustekinumab 6 mg/kg (IP);Drug: Placebo IV - Responder - Placebo SC (MP);Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP);Drug: Ustekinumab IV - Responder - Placebo SC (MP);Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP);Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP);Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)Centocor, Inc.NULLCompleted18 YearsN/AAll526Phase 2United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Netherlands;New Zealand;Spain;United Kingdom
34EUCTR2006-006632-22-BE
(EUCTR)
26/01/200719/12/2006Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trialChange from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA
Trade Name: REMICADE
University of Leuven, Division of GastroenterologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium