Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 August 2016 |
Main ID: |
EUCTR2013-000263-88-BG |
Date of registration:
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17/02/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).
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Scientific title:
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A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis |
Date of first enrolment:
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14/04/2014 |
Target sample size:
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220 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000263-88 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 5
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Bulgaria
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Canada
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France
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Germany
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Hungary
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Netherlands
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Poland
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Romania
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Russian Federation
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Ukraine
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Janssen Biologics BV - Clinical Registry Group- Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+3171524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry Group
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Address:
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Janssen Biologics BV - Clinical Registry Group- Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+3171524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Have a clinical diagnosis of ulcerative colitis (UC) at least 3 months prior to screening
- Have moderately to severely active UC, defined as a baseline (Week 0) Mayo score of 6 to 12 ; including an endoscopy subscore greater than or equal to 2 as determined by a central read of the video endoscopy
- Current treatment with oral corticosteroids or have a history of failure to respond to, or tolerate, at least 1 of the following therapies oral corticosteroids (including budesonide), 6-mercaptopurine (6-MP), azathioprine (AZA), or anti-tumor necrosis factor therapy or be corticosteroid dependent (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC
- Must discontinue 6-MP/AZA for at least 1 week before the first dose of study medication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 209 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria: - At imminent risk for colectomy
- Have ulcerative colitis limited to the rectum only or to less than 20 centimeter of the colon
- Presence of a stoma
- Presence or history of a fistula
- History or current diagnosis of active or latent tuberculosis, human immunodeficiency virus, hepatitis C virus or hepatitis B virus infection
- Have had more than 1 herpes zoster infection or have had any diagnosis disseminated herpes zoster
- Previous treatment with a janus kinase inhibitor (eg, tofacitinib)
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis MedDRA version: 17.1
Level: LLT
Classification code 10045365
Term: Ulcerative colitis
System Organ Class: 100000004856
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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Product Name: JNJ-54781532-AAD-5 mg Pharmaceutical Form: Film-coated tablet Current Sponsor code: JNJ-54781532-AAD Other descriptive name: ASP015K Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: JNJ-54781532-AAD-10 mg Pharmaceutical Form: Film-coated tablet Current Sponsor code: JNJ-54781532-AAD Other descriptive name: ASP015K Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: JNJ-54781532-AAD-30 mg Pharmaceutical Form: Film-coated tablet Current Sponsor code: JNJ-54781532-AAD Other descriptive name: ASP015K Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: 1. To evaluate the dose response of JNJ-54781532 at Week 8 in subjects with moderately to severely active UC. 2. To evaluate the safety of JNJ-54781532 in subjects with moderately to severely active UC.
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Secondary Objective: 1. To evaluate the efficacy of JNJ-54781532 in inducing clinical response at Week 8. 2. To evaluate the efficacy of JNJ-54781532 in inducing clinical remission at Week 8. 3. To evaluate the efficacy of JNJ-54781532 in inducing mucosal healing at Week 8.
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Primary end point(s): Change from baseline in the Mayo score at Week 8
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Timepoint(s) of evaluation of this end point: 8 weeks
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Secondary Outcome(s)
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Secondary end point(s): -Clinical response at Week 8
-Clinical remission at Week 8
-Mucosal healing at Week 8
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Timepoint(s) of evaluation of this end point: 8 weeks
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Secondary ID(s)
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54781532UCO2001
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2013-000263-88-DE
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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