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

NCT04633447 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-07-01

Study results available
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Summary

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).

Conditions

  • Giant Cell Arteritis

Interventions

DRUG

Guselkumab

Guselkumab will be administered subcutaneously.

DRUG

Placebo

Matching placebo will be administered subcutaneously.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2024-05-22
Completion
2024-05-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633447 on ClinicalTrials.gov