A randomized, parallel-group, double-blind, placebo-controlled, multicenter trial to investigate the efficacy and safety of subcutaneously administered secukinumab in patients with new-onset of giant cell arteritis (GCA) who are in clinical remission and eligible for treatment with glucocorticoidmonotherapy (GigAINt)

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512856-40-00

Acronym

CAIN457R1DE01

Enrollment

146

Registered

2024-08-26

Start date

2022-09-21

Completion date

Unknown

Last updated

2025-12-10

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

Conditions

Giant Cell Arteritis

Brief summary

Time from baseline to first GCA clinical relapse

Detailed description

Proportion of participants in sustained clinical remission at Week 52, Efficacy endpoints: - Changes from Baseline to Week 52 in disease activity and quality of life for each of the following: PGA score (VAS), SF-36 (PCS and MCS) score, Patient assessment of pain (NRS) and other assessments - Time from Baseline to reach prednisolone or equivalent dose below ≤7.5 mg/day - Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day at Week 52 - Cumulative prednisolone or equivalent dose through Week 52, Safety and tolerability assessments over time: incidence and severity of AEs and SAEs; routine safety laboratory parameters

Interventions

DRUGCosentyx 300 mg solution for injection in pre-filled syringe

DRUGPlacebo to AIN457 300 mg/2 mL Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time from baseline to first GCA clinical relapse	—

Secondary

Measure	Time frame
Proportion of participants in sustained clinical remission at Week 52, Efficacy endpoints: - Changes from Baseline to Week 52 in disease activity and quality of life for each of the following: PGA score (VAS), SF-36 (PCS and MCS) score, Patient assessment of pain (NRS) and other assessments - Time from Baseline to reach prednisolone or equivalent dose below ≤7.5 mg/day - Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day at Week 52 - Cumulative prednisolone or equivalent dose through Week 52, Safety and tolerability assessments over time: incidence and severity of AEs and SAEs; routine safety laboratory parameters	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

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