A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis (UC)

Phase 2

Withdrawn

Conditions: Chronic inflammation of the intestinal wall
Inflammatory Bowel Disease
10017969

Registration Number: NL-OMON54924

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

1. Male or female, 18 years of age or older
2. Documented diagnosis of UC at least 3 months before screening
3. Moderately to severely active UC as defined by baseline modified Mayo score
4. History of inadequate response to or failure to tolerate conventional or
advanced therapy as defined in the protocol
5. Screening laboratory test results within the study protocol defined
parameters

Please see section 5.1 in the protocol for all inclusion criteria.

Exclusion Criteria

1. Severe extensive colitis as defined in the study protocol
2. UC limited to the rectum only
3. Presence of a stoma
4. Presence or history of a fistula
5. Presence of symptomatic colonic or small bowel obstruction
6. History of extensive colonic resection
7. History of colonic mucosal dysplasia
8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's
disease or clinical findings suggestive of Crohn's disease.

Please see section 5.2 in the protocol for all exclusion criteria.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Induction study 1 & 2:<br /><br>The primary endpoint in this study is clinical response at Induction Week 12<br /><br>(Week I-12).<br /><br><br /><br>Maintenance Study:<br /><br>The primary endpoint in this study is clinical remission at Maintenance Week 44<br /><br>(Week M-44).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Induction study 1:<br /><br>* Clinical remission at Week I-12.<br /><br>* Symptomatic remission at Week I-12.<br /><br>* Endoscopic healing at Week I-12.<br /><br>* Histo-endoscopic healing at Week I-12.<br /><br><br /><br><br /><br>Induction Study 2:<br /><br>* Symptomatic remission at Week I-12.<br /><br>* Endoscopic healing at Week I-12.<br /><br>* Clinical response at Week I-12.<br /><br>* Histo-endoscopic healing at Week I-12.<br /><br>* Symptomatic remission at Week I-4.<br /><br><br /><br>Maintenance Study:<br /><br>* Symptomatic remission at Week M-52.<br /><br>* Endoscopic healing at Week M-52.<br /><br>* Corticosteroid-free (ie, not requiring any treatment with corticosteroids for<br /><br>at least 8 weeks prior) clinical remission at Week M-52.<br /><br>* Clinical response at Week M-52.<br /><br>* Histo-endoscopic healing at Week M-52.<br /><br>* Clinical remission at Week M-52 among the participants who had achieved<br /><br>clinical remission at maintenance baseline.</p><br>