Efficacy and Safety of JNJ-77242113 in Participants with Moderately to Severely Active Ulcerative Colitis

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-504673-20-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

1. 18 (or the legal age of consent in the jurisdiction in which the study is taking place) or older., 2. Documented diagnosis of UC of at least 12 weeks prior to screening, with colitis confirmed at any time in the past by radiography, histology, and/or endoscopy., 3. Moderately to severely active UC, defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy., 4. An endoscopy subscore =2 as obtained during central review of the screening video endoscopy., 5. A participant who had extensive UC for =8 years, or disease limited to the left side of the colon for =10 years, must: a. have had a complete colonoscopy, to assess for the presence of dysplasia within 1 year before the first dose of study intervention. OR b. have a complete colonoscopy with surveillance for dysplasia per local country guidelines at the time of baseline endoscopy performed during the screening period., 6. A participant =45 years of age must either have had a full colonoscopy to assess for the presence of adenomatous polyps within 5 years before the first dose of study intervention or a complete colonoscopy to assess for the presence of adenomatous polyps at the screening visit. The adenomatous polyps must be removed before the first dose of study intervention.

Exclusion Criteria

1. Patients with current or prior diagnosis of fulminant colitis and/or toxic megacolon., 2. UC limited to rectum only or to <15 cm of colon., 3. Presence of a stoma., 4. Presence or history of fistula., 5. Has required or will require surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study intervention treatment within the 8 weeks prior to screening., 7. History of extensive colonic resection (ie, < 30 cm of colon remaining)., 9. History of colonic mucosal dysplasia. Participants will not be excluded from the study because of pathology finding of indefinite for dysplasia with reactive atypia.”, 12. Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, within 4 months before the first dose of study intervention, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. Note: Treatment and repeat testing can occur in the current screening period., 13. Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, biliary, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof.

Study & Design

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