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

Conditions

• Rotator Cuff Tendinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 10, 2023

Status verified

Mar 2026

Primary completion

Oct 17, 2024

Completion

Dec 13, 2024

Study Design

Enrollment

33 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Secukinumab
  Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
• Placebo Comparator: Placebo
  Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.

Primary Outcome Measure

Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16 [ Time Frame: At Week 16 ]

Locations (6)

Related coverage on Hipa.ai

• Secukinumab Phase 3 Trial for Rotator Cuff Tendinopathy Terminated
  Secukinumab · Dec 2, 2025 · ClinicalTrials.gov

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