drugset / Trial / NCT04179175
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).
Timeline
- Start
- 2020-03-18
- Primary completion
- 2023-05-26
- Completion
- 2026-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |