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

Completed · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).

Key facts

Study ID

NCT03662542

Run by

Janssen Research & Development, LLC

People needed

214

Starts

2018-11-20

Expected to finish

2021-11-15

Last updated by the study team

2023-12-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
• Moderately to severely active UC as defined by Mayo score
• History of inadequate response to or failure to tolerate conventional therapy
• Has screening laboratory test results within the study protocol defined parameters
• 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

You may not qualify if…

• Has severe extensive colitis as defined in the study protocol
• Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
• Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
• 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)
• Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients

Where it is running

• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• GCP Clinical Research — Tampa, Florida, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Woodholme Gastroenterology — Glen Burnie, Maryland, United States
• Sierra Clinical Research — Las Vegas, Nevada, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Fargo Gastroenterology Clinic, PC — Fargo, North Dakota, United States
• Texas Digestive Disease Consultants — Southlake, Texas, United States
• Gastroenterology Associates of Tidewater — Chesapeake, Virginia, United States
• Virginia Mason — Seattle, Washington, United States
• Washington Gastroenterology, PLLC — Tacoma, Washington, United States
• CEMIC (Centro de Educación Médica e Investigaciones Clínicas) — Buenos Aires, Argentina
• Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
• Expertia S.A — Caba, Argentina
• Centro Médico Dra. De Salvo — Caba, Argentina
• Clínica Adventista Belgrano — Ciudad de Buenos Aires, Argentina
• Fundacion de Estudios Clinicos — Rosario, Argentina
• Hospital de Alta Complejidad en Red 'El Cruce' — San Juan Bautista, Argentina
• Sanatorio 9 de Julio — San Miguel de Tucumán, Argentina
• Princess Alexandra Hospital — Brisbane, Australia
• St Vincent's Hospital - Melbourne — Fitzroy, Australia
• Nepean Hospital — Kingswood, Australia
• Precision Research Institute — San Diego, California, United States

Full record on ClinicalTrials.gov

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