A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in Litchfield Park, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05528510
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

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

Interventions

  • Guselkumab Dose 1 — DRUG
    Guselkumab (Dose 1) will be administered as SC injection.
  • Guselkumab Dose 2 — DRUG
    Guselkumab (Dose 2) will be administered as SC injection.
  • Guselkumab Dose 3 — DRUG
    Guselkumab (Dose 3) will be administered as SC injection.
  • Placebo — OTHER
    Placebo will be administered as SC injection.

Study Details

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Key Dates

Start date
Sep 13, 2022
Status verified
Jun 2026
Primary completion
Apr 2, 2024
Completion
Oct 6, 2028

Study Design

Enrollment
418 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Guselkumab
    Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
  • Experimental: Group 2: Guselkumab
    Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
  • Placebo Comparator: Group 3: Placebo
    Participants will receive matching placebo SC injection.

Primary Outcome Measure

Percentage of Participants in Clinical Remission at Week 12 [ Time Frame: Week 12 ]

Locations (32)

FacilityCityStateZIPSite coordinators
Research Solutions of ArizonaLitchfield ParkArizona85340-
Om Research LLC 1Apple ValleyCalifornia92307-
Om Research LLCLancasterCalifornia93534-
Medical Associates Research Group, Inc.San DiegoCalifornia92123-
Peak Gastroenterology AssociatesColorado SpringsColorado80907-
Gastro FloridaClearwaterFlorida33762-
I.H.S. Health. LLCKissimmeeFlorida34741-
Columbus Clinical Services LLCMiamiFlorida33125-
Vista Health Research, LLCMiamiFlorida33176-
Orlando HealthOrlandoFlorida32806-
Theia Clincial Research, LLCTemple TerraceFlorida34209-
Atlanta Gastroenterology AssociatesAtlantaGeorgia30342-
Digestive Healthcare of Georgia, P.CAtlantaGeorgia30309-
Gastroenterology Associates of Central GAMaconGeorgia31201-
Cotton O'Neil Digestive Health CenterTopekaKansas66606-
Clinical Research Institute of Michigan, LLCChesterfieldMichigan48047-
Detroit Clinical Research CenterFarmington HillsMichigan48334-
Smart Medical ResearchHollisNew York11423-
University of North CarolinaChapel HillNorth Carolina27599-7080-
Peters Medical ResearchHigh PointNorth Carolina27260-
Dayton Gastroenterology, IncDaytonOhio45415-
Gastro Intestinal Research Institute of Northern Ohio LLCWestlakeOhio44145-
Allegheny General Hospital of ResearchPittsburghPennsylvania15224-
Frontier Clinical ResearchUniontownPennsylvania15401-
Gastroenterology Associates of Orangeburg, SCOrangeburgSouth Carolina29118-
Southern Star Research Institute, LLCSan AntonioTexas78229-
UT Health Science Center at San AntonioSan AntonioTexas78229-
Tyler Research Institute, LLCTylerTexas75701-
Victoria GastroenterologyVictoriaTexas77407-
Care Access Research, OgdenOgdenUtah84403-
Gastroenterology AssociatesSalt Lake CityUtah84124-
Gastroenterology Associates of TidewaterChesapeakeVirginia23320-

Related coverage on Hipa.ai

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By research site
Research Solutions of Arizona· Litchfield Park, AZOm Research LLC 1· Apple Valley, CAOm Research LLC· Lancaster, CAMedical Associates Research Group, Inc.· San Diego, CAPeak Gastroenterology Associates· Colorado Springs, COGastro Florida· Clearwater, FL

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