NCT05569174

Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, 24-week Study Investigating the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Moderate to Severe Rotator Cuff Tendinopathy and Failure to Conventional Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.

Detailed description

This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase IIIb, 24-week study to investigate the superior efficacy of secukinumab and safety in participants with rotator cuff tendinopathy. Secukinumab 300 mg s.c. was compared to placebo (both arms in combination with patient individualized conventional therapy) in relieving clinical symptoms at Week 24. The study consisted of a screening period up to 6 weeks, a 2-week run-in period, a 12-week treatment period and a 12-week follow-up period. Treatment and follow-up periods were blinded. Participants who met the eligibility criteria at screening continued to the run-in period and were randomized. In the run-in period, participants performed 2 weeks of home-based standardized physiotherapy.

Conditions

• Tendinopathy

Interventions

Type	Name	Description
DRUG	Secukinumab	Secukinumab 300 mg s.c for 12 weeks in a pre-filled syringe (PFS)
OTHER	Placebo	Placebo to match secukinumab s.c. for 12 weeks in a PFS

Timeline

• Start date: 2022-12-02
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2022-10-06
• Last updated: 2026-01-23
• Results posted: 2025-12-02

Locations

19 sites across 1 country: Germany