A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07499232
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Key Dates

First listed
Mar 30, 2026
Start date
Apr 21, 2026
Status verified
Jul 2026
Primary completion
Nov 15, 2028
Completion
Dec 11, 2030

Study Design

Enrollment
530 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab
    Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.
  • Experimental: Risankizumab
    Participants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.

Primary Outcome Measure

Number of Participants with Deep Remission at Week 52 [ Time Frame: At Week 52 ]

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the SoutheastDothanAlabama36305-
East View Medical ResearchMobileAlabama36608-
Clinnova ResearchAnaheimCalifornia92805-
United GastroenterologistsLos AlamitosCalifornia90720-
TLC Clinical Research IncLos AngelesCalifornia90048-
Hoag Memorial HospitalNewport BeachCalifornia92663-
Medical Associates Research Group, Inc.San DiegoCalifornia92123-
Peak Gastroenterology AssociatesColorado SpringsColorado80907-
Medical Research Center of ConnecticutHamdenConnecticut06518-
Green Leaf Clinical TrialsJacksonvilleFlorida32258-
Biodax Medical Research TrialsMiamiFlorida33186-
Sanchez Clinical Research, IncMiamiFlorida33157-6575-
GI Pros ResearchNaplesFlorida34102-
GCP Clinical ResearchTampaFlorida33609-
Morehouse School of MedicineAtlantaGeorgia30310-
Gastroenterology Associates of Central GAMaconGeorgia31201-
Cotton-O'Neil Clinical Research CenterTopekaKansas66606-
Gastroenterology Clinic of AcadianaLafayetteLouisiana70503-
Michigan Center of Medical ResearchFarmington HillsMichigan48334-
Westchester Putnam GastroenterologyCarmelNew York10512-
New York Gastroenterology AssociatesNew YorkNew York10075-
Charlotte Gastroenterology and Hepatology, PLLCCharlotteNorth Carolina28207-
Great Lakes Gastroenterology Research, LLCMentorOhio44060-
Digestive Disease Specialists IncOklahoma CityOklahoma73114-
Frontier Clinical ResearchUniontownPennsylvania15401-
Palmetto Primary and Specialty Care Physicians, CharlestonSummervilleSouth Carolina29486-
DFW Clinical TrialsCarrolltonTexas75010-
Lubbock GastroenterologyLubbockTexas79424-
Gastroenterology Research of America, LLCSan AntonioTexas78229-
Southern Star Research Institute, LLCSan AntonioTexas78229-
The University of Texas Health Science Center at TylerTylerTexas75708-

Find similar trials in Dothan, AL

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By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Digestive Health Specialists of the Southeast· Dothan, ALEast View Medical Research· Mobile, ALClinnova Research· Anaheim, CAUnited Gastroenterologists· Los Alamitos, CATLC Clinical Research Inc· Los Angeles, CAHoag Memorial Hospital· Newport Beach, CA

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