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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05569174
Phase
PHASE3
Status
Completed

Conditions

  • Tendinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 2, 2022
Status verified
Jan 2026
Primary completion
Dec 18, 2024
Completion
Dec 18, 2024

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab
    Participants received 300 mg of secukinumab s.c. for 12 weeks
  • Placebo Comparator: Placebo
    Participants received placebo s.c. for 12 weeks

Primary Outcome Measure

Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24 [ Time Frame: Baseline, Week 24 ]

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