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Recruiting NCT07577843

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Phase III Interventional Crohn Disease

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: Crohn Disease. 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, Israel +4
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 Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

Interventions

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

Primary outcome measures

  • Co-Primary: Percentage of Participants with Clinical Remission at Week 48 [Time frame: At Week 48]
  • Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48 [Time frame: At Week 48]
Secondary outcome measures (10)
  • Percentage of Participants with Deep Remission 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 with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48 [Time frame: At Week 48]
  • Percentage of Participants with Sustained Clinical Remission [Time frame: At Weeks 12 and 48]
  • Percentage of Participants with Histologic-Endoscopic 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 Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Mental Component Summary Score (MCS) Response at Week 48 [Time frame: At Week 48]
  • Percentage of Participants with Clinical Remission at Week 12 [Time frame: At Week 12]
  • Percentage of Participants with Endoscopic Response at Week 12 [Time frame: At Week 12]
  • Number of Participants with Adverse Events (AE) and Serious AEs (SAEs) [Time frame: Up to approximately 3 years]

Eligibility 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

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 · 13 centers
  • National Hospital Organization Hirosaki National Hospital — Hirosaki
  • Kagoshima IBD Gastroenterology Clinic — Kagoshima
  • Tsujinaka Hospital Kashiwanoha — Kashiwa
  • Kobe University Hospital — Kobe
  • Kumamoto University Hospital — Kumamoto
  • Japanese Red Cross Kumamoto Hospital — Kumamoto
  • Takano Hospital — Kumamoto
  • Kitasato University Kitasato Institute Hospital — Minatoku
  • … and 5 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
  • Atlanta Gastroenterology Specialists — Suwanee
  • Tri-State Gastroenterology Assoc — Crestview Hills
  • … and 4 more centers
Israel · 10 centers
  • Assuta Medical center — Ashdod
  • Bnai Zion Medical Center — Haifa
  • Rambam 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 · 6 centers
  • GI Research Institute (G.I.R.I.) — Vancouver
  • Viable Clinical Research — Kentville
  • London Digestive Disease Institute — London
  • West GTA Research Inc — Mississauga
  • Toronto Immune and Digestive Health Institute Inc — Toronto
  • CHUM - Centre hospitalier universitaire de Montreal — Montreal
Turkey (Türkiye) · 6 centers
  • Antalya Training And Research Hospital — Antalya
  • Bezmialem University Medical Faculty — Istanbul
  • Marmara University Pendik Training Hospital — Istanbul
  • Izmir Sehir Hastanesi — Izmir
  • Kocaeli University Medical Faculty — Kocaeli
  • Mersin University Medical Faculty — Mersin
Australia · 3 centers
  • Banksia Trials SA — Adelaide
  • IBD SA — Kurralta Park
  • Mater Misericordiae Hospital — South Brisbane
Malaysia · 3 centers
  • Sultan Idris Shah Hospital — Kajang
  • Hospital Queen Elizabeth — Kota Kinabalu
  • Hospital Sultanah Nur Zahirah — Kuala
Brazil · 1 center
  • BR Trials — São Paulo
Taiwan · 1 center
  • Linkou Chang Gung Memorial Hospital — Taoyuan

Identifiers

NCT: NCT07577843 · 78934804CRD3001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗