A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in La Jolla, California.

Sponsor
Janssen-Cilag Ltd.
Study ID
NCT03782376
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ustekinumab approximately 6 mg/kg (IV) — DRUG
    Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
  • Placebo (SC) — DRUG
    Participants will receive SC injection of placebo at Week 0.
  • Placebo (IV) — DRUG
    Participants will receive IV infusion of placebo at Week 0.
  • Ustekinumab 90 mg (SC) Group 1 — DRUG
    Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
  • Ustekinumab 90 mg (SC) Group 2 — DRUG
    Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.

Study Details

The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

Key Dates

Start date
Dec 20, 2018
Status verified
Apr 2025
Primary completion
Aug 19, 2022
Completion
Jan 10, 2023

Study Design

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

Arms

  • Experimental: Group 1: Ustekinumab (IV re-induction)
    Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
  • Active Comparator: Group 2: Ustekinumab (Continuous q8w SC maintenance)
    Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.

Primary Outcome Measure

Percentage of Participants With Clinical Response at Week 16 [ Time Frame: Week 16 ]

Locations (28)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093-
Peak Gastroenterology AssociatesColorado SpringsColorado80907-
Florida Research Network, LLCGainesvilleFlorida32605-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Advent HealthOrlandoFlorida32803-
Florida Hospital TampaTampaFlorida33613-
Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph'sAtlantaGeorgia30342-5020-
Emory UniversityAtlantaGeorgia30322-
Atlanta Gastroenterology SpecialistsSuwaneeGeorgia30024-
University of Kentucky Chandler Medical CenterLexingtonKentucky40536-
Chevy Chase Clinical ResearchChevy ChaseMaryland20815-
Brigham And Women's HospitalBostonMassachusetts02115-
University of Mississippi Medical CenterJacksonMississippi39202-
Washington University School Of MedicineSt LouisMissouri63110-
Mount Sinai School of MedicineNew YorkNew York10029-
Ohio State University HospitalHilliardOhio43026-
Northshore Gastroenterology Research, LLCWestlakeOhio44145-
Oklahoma Digestive Disease SpecialistsOklahoma CityOklahoma73112-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Vanderbilt University Medical CenterNashvilleTennessee37212-
Texas Digestive Disease ConsultantsCedar ParkTexas78613-
Baylor College of MedicineHoustonTexas77025-
Houston Methodist HospitalHoustonTexas77030-2740-
Gastroenterology Research of America, LLCSan AntonioTexas78229-
Tyler Research Institute, LLCTylerTexas75701-
University of WashingtonSeattleWashington98195-
Virginia Mason Medical CenterSeattleWashington98101-
Washington Gastroenterology, PLLCTacomaWashington98405-

Find similar trials in La Jolla, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of California, San Diego· La Jolla, CAPeak Gastroenterology Associates· Colorado Springs, COFlorida Research Network, LLC· Gainesville, FLMayo Clinic Jacksonville· Jacksonville, FLAdvent Health· Orlando, FLFlorida Hospital Tampa· Tampa, FL

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