Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05380453
Phase
PHASE3
Status
Completed

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab 300 mg, s.c. — BIOLOGICAL
    Secukinumab will be administered at a dose of 300 mg as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
  • Placebo to match Secukinumab, s.c. — DRUG
    Placebo will be administered as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.

Study Details

The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.

Key Dates

Start date
Sep 29, 2022
Status verified
Feb 2026
Primary completion
Feb 24, 2026
Completion
Feb 24, 2026

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants will receive placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
  • Experimental: Secukinumab
    Participants will receive secukinumab as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.

Primary Outcome Measure

Time from baseline to first Giant cell arteritis (GCA) clinical relapse [ Time Frame: Time from baseline to first GCA clinical relapse, assessed at least up to Week 24 ]

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