Trial results for secukinumab in patients with rotator cuff tendinopathy were posted on ClinicalTrials.gov on 2025-12-02. The Phase 3 study showed that patients treated with secukinumab achieved a mean change from baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) percentage score of 55.7 at Week 24, compared to 46.8 for those on placebo.
Background
Secukinumab is an investigational treatment for rotator cuff tendinopathy. The trial aimed to investigate its efficacy and safety in adult patients with moderate to severe rotator cuff tendinopathy who had failed conventional therapy.
Trial design
The study (NCT05569174) was a Phase 3, placebo-controlled trial that enrolled 62 participants. It investigated secukinumab subcutaneously compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
Key results
The trial evaluated the change from baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24. For the overall WORC PRO Percentage Score:
- Participants receiving secukinumab achieved a mean change of 55.7 (Standard Deviation: 28.1) on a score scale.
- Participants receiving placebo achieved a mean change of 46.8 (Standard Deviation: 26.9) on a score scale.
For the WORC Percentage Sub-scores at Week 24, the following mean changes were observed:
- Secukinumab group: 48.8 (Standard Deviation: 31.2) vs. Placebo group: 40.0 (Standard Deviation: 25.0).
- Secukinumab group: 51.8 (Standard Deviation: 30.9) vs. Placebo group: 44.0 (Standard Deviation: 30.6).
- Secukinumab group: 59.7 (Standard Deviation: 32.0) vs. Placebo group: 49.9 (Standard Deviation: 30.5).
- Secukinumab group: 59.5 (Standard Deviation: 27.3) vs. Placebo group: 52.9 (Standard Deviation: 26.4).
- Secukinumab group: 64.2 (Standard Deviation: 23.6) vs. Placebo group: 54.3 (Standard Deviation: 31.5).
What this means
The results indicate that secukinumab led to numerically greater improvements in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score and its sub-scores compared to placebo at Week 24. These findings suggest potential efficacy for secukinumab in improving symptoms and function for patients with moderate to severe rotator cuff tendinopathy who have not responded to conventional therapies. Further analysis would be needed to determine statistical significance.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05569174, titled "Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy," were posted on 2025-12-02 on clinicaltrials.gov.
