A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Phase 1

Conditions: Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2018-004002-25-SK

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

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.
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 925
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this study are, in participants with moderately to severely active UC:<br>1. To evaluate the efficacy of guselkumab as induction therapy.<br>2. To evaluate the safety of guselkumab as induction therapy. <br>3. To evaluate the dose-response of guselkumab to inform induction dose selection for the Phase 3 induction study.;Secondary Objective: - To evaluate the impact of guselkumab on health-related quality of life (HRQoL) and health economics outcome measures.<br>- To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy, including changes in C-reactive protein (CRP) and fecal calprotectin.<br>;Primary end point(s): Clinical Response at Induction Week 12 <br><br>;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Clinical remission at Week I-12.<br>- Symptomatic remission at Week I-12.<br>- Endoscopic healing at Week I-12.<br>- Histologic-endoscopic mucosal healing at Week I-12.<br>- Endoscopic normalization at Week I-12.<br><br>A complete list of the efficacy endpoints is provided in Section 9.4.1.1.;Timepoint(s) of evaluation of this end point: Week 44 for maintenance study<br>Week 12 for induction study