A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Key facts

Study ID

NCT05197049

Run by

Janssen Research & Development, LLC

People needed

350

Starts

2022-01-19

Expected to finish

2028-10-30

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Crohn's disease (CD) of at least 3 months in duration
• Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

You may not qualify if…

• Current diagnosis of ulcerative colitis or indeterminate colitis
• Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
• Unstable doses of concomitant Crohn's disease therapy

Where it is running

• Advanced Gastro P.C — Chandler, Arizona, United States
• Reliance Research — Scottsdale, Arizona, United States
• Moore Clinical Trials, LLC — Little Rock, Arkansas, United States
• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• Om Research LLC 1 — Lancaster, California, United States
• Om Research LLC — Lancaster, California, United States
• United Gastroenterologists — Los Alamitos, California, United States
• Paul Wallace MD — Los Angeles, California, United States
• Clinnova Research — Orange, California, United States
• Digestive System Healthcare — Pasadena, California, United States
• Northshore Gastroenterology Research, LLC — San Diego, California, United States
• Clinical Applications Laboratories, Inc — San Diego, California, United States
• Santa Maria Gastroenterology — Santa Maria, California, United States
• Clinical Research of California — Walnut Creek, California, United States
• Amel Med LLC Research — Grand Junction, Colorado, United States
• Western Connecticut Health Network/Danbury Hospital — Danbury, Connecticut, United States
• Gastroenterology Associates of SW Florida — Clearwater, Florida, United States
• Pioneer Research Solutions Inc. — Coconut Creek, Florida, United States
• Omega Research Consultants — DeBary, Florida, United States
• Harmony Medical Research Institute, Inc. — Hialeah, Florida, United States
• Central Florida Gastro Research — Kissimmee, Florida, United States
• Community Research Foundation, Inc. — Miami, Florida, United States
• Gastroenterology Group Of Naples — Naples, Florida, United States
• Center for Digestive Health — Orlando, Florida, United States
• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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