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A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) (GCAptAIN)

Status
Suspended
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510744-31-00
Acronym
CAIN457R12301
Enrollment
243
Registered
2024-07-17
Start date
2021-10-06
Completion date
Unknown
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant cell arteritis (GCA)

Brief summary

Sustained remission at Week 52 as per definition of sustained remission in the protocol.

Detailed description

Time to clinical failure as measured in days through Week 52 per definition of clinical failure in the protocol., Cumulative GC dose through Week 52, Sustained remission at Week 52, Time to clinical failure as measured in days through Week 52, Change in SF-36 score (PCS) at Week 52, Change in Glucocorticoid Toxicity Index (GTI) as measured by the Aggregate Improvement Score (AIS) at Week 52, Change in FACIT-Fatigue score at Week 52, Safety and tolerability demonstrated by assessing: Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship to study drug) Changes in laboratory measures and vital signs

Interventions

DRUGPREDNISONE
DRUGSECUKINUMAB
DRUGPlacebo to Prednisone 1 mg
DRUG2.5mg
DRUG5mg
DRUG20mg hard gelatin capsule with tablet content

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Sustained remission at Week 52 as per definition of sustained remission in the protocol.

Secondary

MeasureTime frame
Time to clinical failure as measured in days through Week 52 per definition of clinical failure in the protocol., Cumulative GC dose through Week 52, Sustained remission at Week 52, Time to clinical failure as measured in days through Week 52, Change in SF-36 score (PCS) at Week 52, Change in Glucocorticoid Toxicity Index (GTI) as measured by the Aggregate Improvement Score (AIS) at Week 52, Change in FACIT-Fatigue score at Week 52, Safety and tolerability demonstrated by assessing: Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship to study drug) Changes in laboratory measures and vital signs

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026