A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; lcerative Colitis; MedDRA version: 17.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856

• Registration Number: EUCTR2013-000263-88-BG
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-17
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To evaluate the dose response of JNJ-54781532 at Week 8 in subjects with moderately to severely active UC.<br>2. To evaluate the safety of JNJ-54781532 in subjects with moderately to severely active UC.;Secondary Objective: 1. To evaluate the efficacy of JNJ-54781532 in inducing clinical response at Week 8.<br>2. To evaluate the efficacy of JNJ-54781532 in inducing clinical remission at Week 8.<br>3. To evaluate the efficacy of JNJ-54781532 in inducing mucosal healing at Week 8.;Primary end point(s): Change from baseline in the Mayo score at Week 8 ;Timepoint(s) of evaluation of this end point: 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Clinical response at Week 8 <br>-Clinical remission at Week 8 <br>-Mucosal healing at Week 8;Timepoint(s) of evaluation of this end point: 8 weeks