A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in San Diego, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03662542
Phase
PHASE2
Status
Completed

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab Dose 1 — DRUG
    Guselkumab Dose 1 will be administered as IV infusion.
  • Guselkumab Dose 2 — DRUG
    Guselkumab Dose 2 will be administered as SC injection.
  • Golimumab Dose 1 — DRUG
    Golimumab Dose 1 will be administered as SC injection.
  • Golimumab Dose 2 — DRUG
    Golimumab Dose 2 will be administered as SC injection.
  • Placebo — DRUG
    Placebo will be administered.

Study Details

The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).

Key Dates

Start date
Nov 20, 2018
Status verified
Nov 2023
Primary completion
Dec 1, 2020
Completion
Nov 15, 2021

Study Design

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

Arms

  • Experimental: Combination Therapy
    Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
  • Experimental: Monotherapy: Guselkumab
    Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
  • Active Comparator: Monotherapy: Golimumab
    Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.

Primary Outcome Measure

Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12 [ Time Frame: Week 12 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Precision Research InstituteSan DiegoCalifornia92114-
Peak Gastroenterology AssociatesColorado SpringsColorado80907-
GCP Clinical ResearchTampaFlorida33609-
Gastrointestinal Specialists of GeorgiaMariettaGeorgia30060-
Indiana UniversityIndianapolisIndiana46202-
Chevy Chase Clinical ResearchChevy ChaseMaryland20815-
Woodholme GastroenterologyGlen BurnieMaryland21061-
Sierra Clinical ResearchLas VegasNevada89106-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Fargo Gastroenterology Clinic, PCFargoNorth Dakota58103-
Texas Digestive Disease ConsultantsSouthlakeTexas76092-
Gastroenterology Associates of TidewaterChesapeakeVirginia23320-
Virginia MasonSeattleWashington98101-
Washington Gastroenterology, PLLCTacomaWashington98405-

Find similar trials in San Diego, CA

By research site
Precision Research Institute· San Diego, CAPeak Gastroenterology Associates· Colorado Springs, COGCP Clinical Research· Tampa, FLGastrointestinal Specialists of Georgia· Marietta, GAIndiana University· Indianapolis, INChevy Chase Clinical Research· Chevy Chase, MD

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