A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-001510-15-DE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-19
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
2. Moderately to severely active UC as defined by Mayo score
3. History of inadequate response to or failure to tolerate conventional therapy
4. Has screening laboratory test results within the study protocol defined parameters
5. A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin pregnancy test result at screening and a negative urine pregnancy test result at Week 0

For all inclusion criteria, please refer to section 5.1 in the protocol amendment 1
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 210
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Has severe extensive colitis as defined in the study protocol
2. Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
3. Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
4. Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
5. Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients

For all exclusion criteria, please refer to section 5.2 in the protocol amendment 1

Study & Design

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