Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
NCT05722522 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2026-03-24
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
- 2023-08-10
- Primary Completion
- 2024-10-17
- Completion
- 2024-12-13
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Bulgaria
- Canada
- Czechia
- Malaysia
- Portugal
Study Locations
More Related Trials
-
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
NCT02696031 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
NCT01350804 ·Status: COMPLETED ·Phase: PHASE3
-
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
NCT02159053 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
NCT04732117 ·Status: COMPLETED ·Phase: PHASE3
-
16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
NCT01649375 ·Status: COMPLETED ·Phase: PHASE3
-
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
NCT02294227 ·Status: COMPLETED ·Phase: PHASE3
-
Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.
NCT01770379 ·Status: TERMINATED ·Phase: PHASE3
-
Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
NCT04156620 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
NCT02750592 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
NCT02404350 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
NCT05622708 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
NCT01359943 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).
NCT05206591 ·Status: WITHDRAWN ·Phase: PHASE3
-
Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
NCT03350815 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis
NCT01752634 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement
NCT02721966 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
NCT01377012 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Influencing Factors of Secukinumab in Patients With Axial Spondyloarthritis
NCT07130331 ·Status: COMPLETED
-
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
NCT03259074 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis
NCT02429882 ·Status: WITHDRAWN ·Phase: PHASE2
-
Treat-to-target With Secukinumab in Axial Spondyloarthritis
NCT03639740 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX
NCT01855789 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis
NCT05303285 ·Status: RECRUITING ·Phase: PHASE4
-
Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
NCT06905288 ·Status: RECRUITING
-
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
NCT00928512 ·Status: COMPLETED ·Phase: PHASE2