CompletedPhase 3

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

Germany151 participantsStarted 2022-09-29

Plain-language summary

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.

Who can participate

Age range50 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent must be obtained prior to participation in the study.
✓. Participant must be able to understand and communicate with the investigator and comply with the requirements of the study.
✓. Male or female participants at least 50 years of age.
✓. Diagnosis of new-onset GCA, defined as GCA diagnosed within 6 weeks of baseline (BSL) visit, based on meeting all of the following criteria:
✓. Participants must be in clinical remission at BSL:
✓. Participants with no relapsing GCA at BSL:
✓. Prednisolone or equivalent dose (oral) of 20-60 mg/day or equivalent dose of other glucocorticoids (GCs) at BSL.

What they're measuring

Time from baseline to first Giant cell arteritis (GCA) clinical relapse

Timeframe: Time from baseline to first GCA clinical relapse, assessed at least up to Week 24

Trial details

NCT IDNCT05380453

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-24

View on ClinicalTrials.gov More Giant Cell Arteritis trials