A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Immune System Diseases [C20]; lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856

• Registration Number: EUCTR2014-005606-38-BE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-08
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 951

Inclusion Criteria

- Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening
- Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (>=) 2 as determined by a central reading of the video endoscopy
- Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following:
a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6 mercaptopurine [6-MP] or azathioprine [AZA]) OR
b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR
c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
- Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and antitumor necrosis factors (TNFs) [or approved biosimilars for these therapies] for at least 8 weeks
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 751
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

- Has severe extensive colitis and is at imminent risk of colectomy
- Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon
- Presence of a stoma or history of a fistula
- Participants with history of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity
- Participants with history of colonic mucosal dysplasia
- Participants will not be excluded from the study because of a pathology finding of indefinite dysplasia with reactive atypia''

Study & Design

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