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Recruiting NCT07577856

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

Phase III Interventional Colitis, Ulcerative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JNJ-78934804, Guselkumab.
Who it may be relevant to
Registry conditions: Colitis, Ulcerative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Brazil, Canada, China +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Overview

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).

Interventions

  • Drug JNJ-78934804
    JNJ-78934804 will be administered subcutaneously.
  • Drug Guselkumab
    Guselkumab will be administered subcutaneously.

Primary outcome measures

  • Percentage of Participants in Clinical Remission at Week 48 [Time frame: At Week 48]
Secondary outcome measures (12)
  • Percentage of Participants with Endoscopic Improvement at Week 48 [Time frame: At Week 48]
  • Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48 [Time frame: At Week 48]
  • Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48 [Time frame: At Week 48]
  • Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48 [Time frame: At Week 48]
  • Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0 [Time frame: At Weeks 12, 24, and 48]
  • Percentage of Participants in Abdominal Pain Remission at Week 48 [Time frame: At Week 48]
  • Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48 [Time frame: At Week 48]
  • Percentage of Participants with PROMIS-29 Mental Component Summary (MCS) Response at Week 48 [Time frame: At Week 48]
  • Percentage of Participants in Clinical Remission at Week 12 [Time frame: At Week 12]
  • Percentage of Participants with Endoscopic Improvement at Week 12 [Time frame: At Week 12]
  • Percentage of Participants with Mayo SF/RB Response at Week 2 [Time frame: At Week 2]
  • Percentage of Participants with Adverse Events (AE) and Serious AEs (SAEs) [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Japan · 14 centers
  • Matsuda Hospital — Hamamatsu
  • National Hospital Organization Mito Medical Center — Higashi-Ibaraki
  • Kagoshima IBD Gastroenterology Clinic — Kagoshima
  • Tsujinaka Hospital Kashiwanoha — Kashiwa
  • Kumamoto University Hospital — Kumamoto
  • Takano Hospital — Kumamoto
  • Kitasato University Kitasato Institute Hospital — Minatoku
  • National Hospital Organization Osaka National Hospital — Osaka
  • … and 6 more centers
United States · 12 centers
  • Clinnova Research — Anaheim
  • Gastro SB Clinic — Chula Vista
  • Medical Associates Research Group, Inc. — San Diego
  • Peak Gastroenterology Associates — Colorado Springs
  • Sanchez Clinical Research, Inc — Miami
  • GCP Clinical Research — Tampa
  • Tri-State Gastroenterology Assoc — Crestview Hills
  • Michigan Center of Medical Research — Farmington Hills
  • … and 4 more centers
Israel · 10 centers
  • Assuta Medical center — Ashdod
  • Rambam Medical Center — Haifa
  • Bnai Zion Medical Center — Haifa
  • Wolfson Medical Center — Holon
  • Shaare Zedek Medical Center — Jerusalem
  • Meir Medical Center — Kfar Saba
  • Galilee Medical Center — Nahariya
  • Rabin Medical Center — Petah Tikva
  • … and 2 more centers
Canada · 8 centers
  • South Edmonton Gastroenterology Research Clinic — Edmonton
  • GI Research Institute (G.I.R.I.) — Vancouver
  • Viable Clinical Research — Kentville
  • Barrie GI Associates — Barrie
  • Charlton Digestive Disease Centre — Hamilton
  • London Digestive Disease Institute — London
  • Toronto Immune and Digestive Health Institute Inc — Toronto
  • CHUM - Centre hospitalier universitaire de Montreal — Montreal
Turkey (Türkiye) · 7 centers
  • Antalya Training And Research Hospital — Antalya
  • Sanko Universitesi Hastanesi — Gaziantep
  • Bezmialem University Medical Faculty — Istanbul
  • Istanbul University Cerrahpasa Medical Faculty — Istanbul
  • Izmir Sehir Hastanesi — Izmir
  • Kocaeli University Medical Faculty — Kocaeli
  • Mersin University Medical Faculty — Mersin
Malaysia · 4 centers
  • Hospital Ampang — Ampang
  • Sultan Idris Shah Hospital — Kajang
  • Hospital Kuala Lumpur — Kuala Lumpur
  • Hospital Sultanah Nur Zahirah — Kuala Terengganu
Australia · 3 centers
  • Banksia Trials SA — Adelaide
  • SA Gastrointestinal Services — Kurralta Park
  • Mater Misericordiae Hospital — South Brisbane
Brazil · 2 centers
  • Pesquisare Saude — Santo André
  • BR Trials — São Paulo
China · 1 center
  • The First Affiliated Hospital Sun Yat sen University — Guangzhou
South Korea · 1 center
  • Samsung Medical Center — Gangnam Gu
Taiwan · 1 center
  • Linkou Chang Gung Memorial Hospital — Taoyuan

Identifiers

NCT: NCT07577856 · 78934804UCO3001 · 2026-525923-26-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗