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
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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

Start date
Apr 21, 2026
Status verified
Jun 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 (17)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the SoutheastDothanAlabama36305-
Clinnova ResearchAnaheimCalifornia92805-
United GastroenterologistsLos AlamitosCalifornia90720-
TLC Clinical Research IncLos AngelesCalifornia90048-
Hoag Memorial HospitalNewport BeachCalifornia92663-
Peak Gastroenterology AssociatesColorado SpringsColorado80907-
Sanchez Clinical Research, IncMiamiFlorida33157-6575-
GCP Clinical ResearchTampaFlorida33609-
Cotton-O'Neil Clinical Research CenterTopekaKansas66606-
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-
Southern Star Research Institute, LLCSan AntonioTexas78229-

Find similar trials in Dothan, AL

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Digestive Health Specialists of the Southeast· Dothan, ALClinnova Research· Anaheim, CAUnited Gastroenterologists· Los Alamitos, CATLC Clinical Research Inc· Los Angeles, CAHoag Memorial Hospital· Newport Beach, CAPeak Gastroenterology Associates· Colorado Springs, CO

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