drugset / Trial / NCT03344640
Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without systemic inflammatory disease.
Timeline
- Start
- 2017-12-15
- Primary completion
- 2019-08-02
- Completion
- 2019-10-17
Outcome
Missed primary endpoint
registry analysis (superiority test); Secukinumab vs Placebo; p = 0.875; Mean Difference (Final Values) -0.77 (90% CI -8.84 to 7.30); LS mean NCT03344640 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |