97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,527 薬物数 : 1,468 - (DrugBank : 259) / 標的遺伝子数 : 143 - 標的パスウェイ数 : 201

  
32 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT05186623
(ClinicalTrials.gov)
February 5, 202222/12/2021Prediction Model for Response to Biologics and Small Molecular Agent for UCEstablishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal DataUlcerative ColitisDrug: Vedolizumab, Ustekinumab, or TofacitinibAsan Medical CenterNULLRecruiting18 Years79 YearsAll300Korea, Republic of
2JPRN-jRCT2041200098
28/10/202102/02/2021A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC)A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis Colitis, Ulcerative-Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Induction Period (I):Ustekinumab
Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)

-Matching Placebo
Placebo will be administered subcutaneously.
Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)
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
3EUCTR2020-004457-76-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
4NCT04963725
(ClinicalTrials.gov)
July 18, 20218/7/2021A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical PracticeSymptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported OutcomesUlcerative ColitisDrug: UstekinumabJanssen Pharmaceutical K.K.NULLRecruiting16 YearsN/AAll140Japan
5NCT04372108
(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
6NCT04630028
(ClinicalTrials.gov)
March 17, 202113/11/2020A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)A 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 Ulcerative ColitisColitis, UlcerativeDrug: Ustekinumab Dose Based on BSA and Body Weight;Drug: Matching PlaceboJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll90Phase 3United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom
7EUCTR2019-004224-38-DE
(EUCTR)
25/02/202120/10/2020A 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 Ulcerative ColitisA 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 Ulcerative Colitis - UNIFI-Jr Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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
8JPRN-jRCT1031200329
28/01/202128/01/2021UC Bio StudyOpen-ravel randomized control trial to evaluate the efficacy of biologics for ulcerative colitis with treatment-refractoriness Ulcerative colitis
Biologics;D003093
Infliximab:Infliximab (5 mg / kg / body weight) is infused intravenously at 0, 2, 6, 14, and 22 weeks.
Vedolizumab:Intravenous infusion of vedolizumab 300 mg at 0, 2, 6, 14, and 22 weeks
Ustekinumab: a single intravenous infusion of the dose shown below is given at the first induction therapy.
Body weight dose
55kg or less 260mg
55-85kg 390mg
85kg or more 520mg

After 8_weeks of intravenous drip infusion, 90 mg of ustekinumab is usually subcutaneously administered to adults, and 90 mg is subcutaneously administered at 12-week intervals thereafter. If the effect is diminished, the dosing interval can be shortened to 8 weeks.
Naganuma MakotoNULLRecruiting>= 16age oldNot applicableBoth231N/AJapan
9EUCTR2019-004224-38-HU
(EUCTR)
30/12/202022/10/2020A 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 Ulcerative ColitisA 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 Ulcerative Colitis - UNIFI-Jr Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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
10EUCTR2019-004652-11-SI
(EUCTR)
28/08/202031/08/2020A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative ColitisRANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Etrolizumab
Product Code: RO5490261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany
11NCT03885713
(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
12EUCTR2018-002925-47-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
13NCT03606499
(ClinicalTrials.gov)
September 26, 201820/7/2018Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory DiseasesEffectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world SettingCrohn Disease;Colitis, UlcerativeDrug: UstekinumabJanssen Cilag S.A.S.NULLRecruiting18 YearsN/AAll214France
14NCT03358706
(ClinicalTrials.gov)
February 2, 201827/11/2017A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative ColitisA Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.Crohn Disease;Ulcerative ColitisDrug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mgJanssen Research & Development, LLCNULLRecruiting18 Years75 YearsAll57Phase 1United States;Belgium;Germany;United Kingdom;Austria;Denmark;Sweden
15EUCTR2014-005606-38-PL
(EUCTR)
05/02/201617/11/2015A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
16EUCTR2014-005606-38-DK
(EUCTR)
02/11/201530/06/2015A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
17EUCTR2014-005606-38-SK
(EUCTR)
22/10/201507/07/2015A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
18EUCTR2014-005606-38-BG
(EUCTR)
21/10/201503/09/2015A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Bulgaria;South Africa;Netherlands;Germany;New Zealand;Korea, Republic of
19EUCTR2014-005606-38-IT
(EUCTR)
13/10/201522/01/2021A Study to Evaluate the Safety and Efficacy of the Ustekinumab Inductionand Maintenance Therapy in Participants with Moderately to SeverelyActive Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group,Multicenter Protocol to Evaluate the Safety and Efficacy of UstekinumabInduction and Maintenance Therapy in Subjects with Moderately toSeverely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
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
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
951Phase 3Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
20EUCTR2014-005606-38-DE
(EUCTR)
07/10/201504/05/2015A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
21JPRN-JapicCTI-163122
24/9/201506/01/2016A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Colitis, Ulcerative, Inflammatory Bowel DiseasesIntervention name : Ustekinumab
INN of the intervention : Ustekinumab
Dosage And administration of the intervention : week 0: Participants will be randomized to receive single dose of placebo, Ustekinumab 130mg or Ustekinumab 6 mg/kg as Intravenous (IV: into the vein) infusion at Week 0. At week 8: Participants without clinical response to placebo will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo. Participants without clinical response to ustekinumab (130 mg or 6 mg/kg [IV]) will receive a single dose of ustekinumab 90 mg SC along with matching placebo IV. Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized. Participants in clinical response will be randomized to receive placebo SC, ustekinumab 90 mg SC every 12 weeks or 90 mg subcutaneously every 8 weeks beginning Week 0 of Maintenance study through Week 44.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Janssen Pharmaceutical K.K.NULLcomplete18BOTH92Phase 3Japan, Asia except Japan, North America, Europe, Oceania
22EUCTR2014-005606-38-BE
(EUCTR)
24/09/201508/07/2015A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
23EUCTR2014-005606-38-NL
(EUCTR)
16/09/201503/07/2015A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Germany;Netherlands;New Zealand;Korea, Republic of
24EUCTR2014-005606-38-CZ
(EUCTR)
27/08/201526/06/2015A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
25EUCTR2014-005606-38-HU
(EUCTR)
12/08/201516/06/2015A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
26EUCTR2014-005606-38-AT
(EUCTR)
20/07/201516/06/2015A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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 NVNULLNot RecruitingFemale: yes
Male: yes
951Phase 3United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
27NCT02407236
(ClinicalTrials.gov)
July 10, 201530/3/2015A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, Ulcerative;Inflammatory Bowel DiseasesDrug: Placebo IV;Drug: Placebo SC;Drug: Ustekinumab IV;Drug: Ustekinumab SCJanssen Research & Development, LLCNULLCompleted18 YearsN/AAll961Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic;South Africa
28EUCTR2019-004224-38-GB
(EUCTR)
25/11/2020A 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 Ulcerative ColitisA 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 Ulcerative Colitis - UNIFI-Jr Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 NVNULLNAFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;Japan;United Kingdom
29EUCTR2019-004224-38-PL
(EUCTR)
04/12/2020A 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 Ulcerative ColitisA 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 Ulcerative Colitis - UNIFI-Jr Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 NVNULLNAFemale: yes
Male: yes
90Phase 3United States;Hungary;Belgium;Poland;Russian Federation;Germany;United Kingdom;Japan
30EUCTR2019-004224-38-Outside-EU/EEA
(EUCTR)
25/01/2021A 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 Ulcerative ColitisA 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 Ulcerative Colitis - UNIFI-Jr Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 NVNULLNAFemale: yes
Male: yes
Phase 3Japan;Russian Federation;United States;Belgium;Germany;Hungary;Poland;United Kingdom
31EUCTR2019-004224-38-BE
(EUCTR)
19/04/2021A 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 Ulcerative ColitisA 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 Ulcerative Colitis - UNIFI-Jr Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 NVNULLNAFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
32EUCTR2020-004457-76-FR
(EUCTR)
27/08/2021A 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 NVNULLNAFemale: yes
Male: yes
180Phase 3United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Hungary;Argentina;Belgium;Poland;Germany;Japan