NCT05758415

Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy

A Randomized, Parallel-group, 24 Week, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Active Rotator Cuff Tendinopathy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study was to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in participants with moderate to severe rotator cuff tendinopathy (RCT), using a randomized, double-blind, placebo controlled, parallel group design to minimize bias.

Detailed description

This was a randomized, double-blind, placebo-controlled Phase III study, stratified by tear status (no tear/ partial tear) in participants with moderate to severe rotator cuff tendinopathy (RCT), experiencing active disease from at least 6 weeks to 6 months at baseline, and were refractory to standard of care (non-steroidal anti-inflammatory drug \[NSAIDs\] and course of physiotherapy) over a period of 8 weeks. The study was terminated due to the project being discontinued in order to prioritize other key programs in the portfolio. Due to the early termination and small sample size, the analysis by tear status stratification was not performed. The study duration was up to 32 weeks, consisting of a screening period lasting up to 8 weeks (inclusive of a mandatory 2-week run-in period), a 16-week treatment period with last dose administered at Week 12, and an 8-week safety follow-up period. The primary endpoint assessment was at Week 16, and the safety follow-up data collection was through to Week 24.

Conditions

• Rotator Cuff Tendinopathy

Interventions

Type	Name	Description
DRUG	Secukinumab	2 X secukinumab 150 mg / 1 mL as solution for subcutaneous (s.c.) injection
DRUG	Placebo	2 X placebo / 1 mL as solution for s.c. injection

Timeline

• Start date: 2023-08-02
• Primary completion: 2024-10-17
• Completion: 2024-12-11
• First posted: 2023-03-07
• Last updated: 2025-12-18
• Results posted: 2025-12-18

Locations

24 sites across 6 countries: United States, China, Italy, Poland, Spain, Thailand

Regulatory

• FDA-regulated drug study