A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
Janssen Research & Development, LLC · NCT07577843
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 460
- US sites recruiting
- 22
- Study start
- May 22, 2026
- Record last updated
- October 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive [worsens with time] and life-threatening disease of the intestine).
Being studied: JNJ-78934804; Guselkumab
Conditions: Crohn Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion criteria
- Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
- Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (\<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
- Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
- Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies
Exclusion criteria
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
- Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
- Presence of draining (that is, functioning) stoma or ostomy
- Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
- Currently has or is suspected of having an abscess
Recruiting US locations
Clinnova Research
Anaheim, CA 92805
Gastro SB Clinic
Chula Vista, CA 91910
United Medical Doctors
Los Alamitos, CA 90720
Medical Associates Research Group, Inc.
San Diego, CA 92123
Peak Gastroenterology Associates
Colorado Springs, CO 80907
Florida Research Center Inc.
Lakewood Rch, FL 34211
Sanchez Clinical Research, Inc
Miami, FL 33157-6575
GCP Clinical Research
Tampa, FL 33609
Atlanta Gastroenterology Specialists
Suwanee, GA 30024
Tri-State Gastroenterology Assoc
Crestview Hills, KY 41017
Gastroenterology Clinic of Acadiana
Lafayette, LA 70503
GIA Metairie
Metairie, LA 70006
Michigan Center of Medical Research
Farmington Hills, MI 48334
GIA Kansas City
Lee's Summit, MO 64086
New York Gastroenterology Associates
New York, NY 10075
University of North Carolina Hospital
Chapel Hill, NC 27599-7080
Great Lakes Gastroenterology Research, LLC
Mentor, OH 44060
Digestive Disease Specialists Inc
Oklahoma City, OK 73114
The Oregon Clinic
Portland, OR 97220
Gastro One
Cordova, TN 38018
Tyler Research Institute, LLC
Tyler, TX 75701
GI Alliance Tacoma
Tacoma, WA 98405
Study contacts (from the official record)
- Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com