A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

NCT07577856 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 78934804UCO30012026-525923-26-00
• Study Type: interventional
• Target: 644
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in Clinical Remission at Week 48

  Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.

  At Week 48

Secondary Outcomes (12)

• Percentage of Participants with Endoscopic Improvement at Week 48

  At Week 48

• Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48

  At Week 48

• Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48

  At Week 48

• Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48

  At Week 48

• Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0

  At Weeks 12, 24, and 48

Study Arms (2)

JNJ-78934804

EXPERIMENTAL

Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind (DB) treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.

Drug: JNJ-78934804

Guselkumab

ACTIVE COMPARATOR

Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete DB treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.

Drug: JNJ-78934804; Drug: Guselkumab

Interventions

JNJ-78934804 DRUG

JNJ-78934804 will be administered subcutaneously.

Also known as: JNJ-4804

Guselkumab; JNJ-78934804

Guselkumab DRUG

Guselkumab will be administered subcutaneously.

Also known as: TREMFYA

Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
• Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
• An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy
• Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies

You may not qualify if:

• Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis
• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
• Has a history of or ongoing chronic or recurrent infectious disease
• Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
• Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): August 11, 2028
• Study Completion (Estimated): October 30, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share