Trial results for the Phase 3 study (NCT05722522) investigating secukinumab for participants with moderate-severe rotator cuff tendinopathy were posted on ClinicalTrials.gov on 2025-12-02. The study was officially terminated, but reported some outcome measurements. For instance, at Week 24, the mean change from baseline in WORC PSD score was 51.19 for secukinumab versus 43.67 for placebo.
Background
The study investigated secukinumab in participants diagnosed with moderate to severe rotator cuff tendinopathy (RCT). Rotator cuff tendinopathy is a common condition affecting the shoulder.
Trial design
The study (NCT05722522) was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group trial. It enrolled 33 participants with moderate to severe rotator cuff tendinopathy. Participants received either secukinumab 300 mg s.c. or placebo, each in combination with standard of care. The trial was designed to assess the efficacy of secukinumab in improving signs, symptoms, and physical function; however, the study was terminated.
Key results
The trial reported several outcome measurements, despite its termination. For the "Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16":
- The Secukinumab group showed a mean change of 45.89 (Standard Deviation: 25.490).
- The Placebo group showed a mean change of 38.40 (Standard Deviation: 29.908).
For the "Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score":
- The Secukinumab group showed a mean change of 13.86 (Standard Deviation: 10.535).
- The Placebo group showed a mean change of 13.78 (Standard Deviation: 11.098).
Regarding the "Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 16":
- 52.9% of participants in the Secukinumab group achieved this.
- 53.3% of participants in the Placebo group achieved this.
For the "Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score":
- 64.7% of participants in the Secukinumab group achieved this.
- 43.8% of participants in the Placebo group achieved this.
At Week 24, for the "Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score":
- 66.7% of participants in the Secukinumab group achieved this.
- 61.5% of participants in the Placebo group achieved this.
Also at Week 24, for the "Change From Baseline in WORC PSD Score":
- The Secukinumab group showed a mean change of 51.19 (Standard Deviation: 26.664).
- The Placebo group showed a mean change of 43.67 (Standard Deviation: 34.661).
What this means
The Phase 3 trial for secukinumab in moderate-severe rotator cuff tendinopathy was terminated. Despite the termination, the posted results indicate some trends. Secukinumab showed a numerically higher mean improvement in WORC PSD scores at both Week 16 and Week 24 compared to placebo. Additionally, a higher percentage of participants on secukinumab achieved at least a 50-point improvement in WORC Total Score compared to placebo. However, the small enrollment of 33 participants and the trial's termination limit the definitive conclusions that can be drawn from these results regarding the efficacy of secukinumab for this condition.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05722522, titled "Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy," were posted on 2025-12-02 on clinicaltrials.gov.