Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
NCT05758415 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-12-18
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.
Conditions
- Rotator Cuff Tendinopathy
Interventions
- DRUG
-
Secukinumab
2 X secukinumab 150 mg / 1 mL as solution for subcutaneous (s.c.) injection
- DRUG
-
2 X placebo / 1 mL as solution for s.c. injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-02
- Primary Completion
- 2024-10-17
- Completion
- 2024-12-11
- FDA Drug
- Yes
Countries
- United States
- China
- Italy
- Poland
- Spain
- Thailand
Study Locations
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