Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

Conditions

• Giant Cell Arteritis (GCA)

Eligibility Criteria

Sex

ALL

Age

50 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Secukinumab 300 mg — BIOLOGICAL
  Secukinumab 300 mg
• Placebo — OTHER
  Placebo
• Secukinumab 150 mg — BIOLOGICAL
  Secukinumab

Study Details

This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)

Key Dates

Start date

Oct 6, 2021

Status verified

Mar 2026

Primary completion

Apr 11, 2025

Completion

Feb 18, 2026

Study Design

Enrollment

354 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Secukinumab 300 mg
  Secukinumab 300 mg s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Secukinumab will be given in combination with a specified 26-week prednisone taper regimen. After the 26-week prednisone taper, participants will continue to receive placebo to prednisone until Week 52.
• Placebo Comparator: Placebo
  Placebo to secukinumab s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Placebo will be given in combination with a specified 52-week prednisone taper regimen.
• Experimental: Secukinumab 150 mg
  Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Secukinumab will be given in combination with a specified 26-week prednisone taper regimen. After the 26-week prednisone taper, participants will continue to receive placebo to prednisone until Week 52.

Primary Outcome Measure

Proportion of participants with sustained remission [ Time Frame: 52 weeks ]

Locations (10)

Related coverage on Hipa.ai

• Secukinumab Phase 3 GCA Trial Completes Primary Data Collection
  Secukinumab · Apr 11, 2025 · ClinicalTrials.gov

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