Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

Part of paid clinical trials in San Francisco, California.

Sponsor
Janssen-Cilag Ltd.
Study ID
NCT06408935
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered IV and SC.

Study Details

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

Key Dates

Start date
Apr 17, 2024
Status verified
Jun 2026
Primary completion
Jun 8, 2027
Completion
Mar 6, 2028

Study Design

Enrollment
120 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab
    Participants will receive guselkumab 200 milligram (mg) intravenously (IV) at week 0, 4 and 8. Afterwards, participants will be alternately assigned at study level to 2 dose cohorts, high dose (200 mg subcutaneous (SC) every 4 weeks (Q4W) starting at week 12) through week 92 or low dose (100 mg SC every 8 weeks (Q8W) starting at week 16) through week 88. Starting at Week 24, participants in the low-dose cohort will be permitted to escalate to the 200 mg SC Q4W regimen if they are symptomatic and at the discretion of the investigator.

Primary Outcome Measure

Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48 [ Time Frame: At Week 48 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Center for Colitis and Crohns Disease University of CaliforniaSan FranciscoCalifornia94115-
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637-
Washington University School Of MedicineSt LouisMissouri63110-
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in San Francisco, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Center for Colitis and Crohns Disease University of California· San Francisco, CAThe University of Chicago Medical Center (UCMC)· Chicago, ILWashington University School Of Medicine· St Louis, MOMedical University of South Carolina· Charleston, SC

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