A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04633447
Phase
PHASE2
Status
Terminated

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

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

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered subcutaneously.
  • Placebo — DRUG
    Matching placebo will be administered subcutaneously.

Study Details

The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).

Key Dates

Start date
Dec 10, 2020
Status verified
Jun 2025
Primary completion
May 22, 2024
Completion
May 22, 2024

Study Design

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

Arms

  • Experimental: Guselkumab
    Participants will receive guselkumab subcutaneously (SC) every 4 weeks from Week 0 through Wweek 48. This will be in combination with a protocol specified 26-week GC taper. Participants of the long-term extension (LTE) period will continue to receive subcutaneous (SC) injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a Giant cell arteritis (GCA) flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.
  • Experimental: Placebo
    Participants will receive matching placebo SC every 4 weeks from Week 0 through Week 48. This will be in combination with a protocol-specified 26-week GC taper. Participants of the LTE period will continue to receive SC injections every 4 weeks starting at Week 52 (LTE Week 0) through Week 100 (LTE Week 48) or until the participants have a GCA flare, or the participants discontinues treatment due to unblinding after the Week 60 DBL for the Main study, or until a decision is made not to continue clinical development in this GCA population, whichever occurs first.

Primary Outcome Measure

Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28 [ Time Frame: Week 28 ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160-
Massachusetts General HospitalBostonMassachusetts02114-

Related coverage on Hipa.ai

Find similar trials in Kansas City, KS

By research site
University of Kansas Medical Center· Kansas City, KSMassachusetts General Hospital· Boston, MA

Related Studies