Trial results for secukinumab in participants with moderate-severe rotator cuff tendinopathy were posted on ClinicalTrials.gov on 2025-12-18. The Phase 3 study investigated secukinumab 300 mg s.c. compared to placebo, each with standard of care. At Week 24, participants receiving secukinumab showed a mean improvement of 35.79 in the WORC Physical Symptom Domain (PSD) score, compared to 27.36 for placebo.
Background
The study, titled 'Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy,' aimed to assess secukinumab in individuals diagnosed with moderate to severe rotator cuff tendinopathy (RCT).
Trial design
The study (NCT05758415) was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group trial that enrolled 60 participants. The trial investigated secukinumab 300 mg s.c. in combination with standard of care, compared to placebo plus standard of care, for participants with moderate to severe rotator cuff tendinopathy. The study's purpose was to assess efficacy and safety.
Key results
The trial evaluated several outcomes related to physical symptoms and upper extremity function. For the outcome 'Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16':
- Participants receiving secukinumab achieved a mean change of 30.90 score on a scale (Standard Deviation: 19.250).
- Participants receiving placebo achieved a mean change of 28.69 score on a scale (Standard Deviation: 27.320).
For the outcome '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 7.56 score on a scale (Standard Deviation: 6.776).
- The placebo group showed a mean change of 8.48 score on a scale (Standard Deviation: 9.744).
Regarding the percentage of participants achieving a significant improvement in WORC PSD score:
- At Week 16, 28.6 percentage of participants in the secukinumab group achieved an improvement of at least 40 points from baseline in the WORC PSD score, compared to 36.4 percentage of participants in the placebo group.
- At Week 24, 42.9 percentage of participants in the secukinumab group achieved an improvement of at least 40 points from baseline in the WORC PSD score, compared to 33.3 percentage of participants in the placebo group.
For the outcome 'Change From Baseline in WORC PSD Score at Week 24':
- The secukinumab group showed a mean change of 35.79 score on a scale (Standard Deviation: 21.374).
- The placebo group showed a mean change of 27.36 score on a scale (Standard Deviation: 27.663).
For the outcome 'Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score':
- 28.6 percentage of participants in the secukinumab group achieved this, compared to 29.2 percentage of participants in the placebo group.
What this means
The posted data from this Phase 3 trial provides insights into the effects of secukinumab on moderate to severe rotator cuff tendinopathy. While some outcomes, such as the mean change in WORC PSD score and the percentage of participants achieving a 40-point improvement at Week 24, showed a numerically greater improvement in the secukinumab group compared to placebo, other outcomes at earlier time points or different measures did not show a consistent advantage. The study was terminated, and without statistical analyses or a defined primary endpoint result, definitive conclusions about the efficacy of secukinumab in this indication cannot be drawn from these posted measurements alone. Clinicians and researchers can review these detailed results to understand the observed changes in patient-reported outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05758415, titled 'Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy,' were posted on 2025-12-18 on clinicaltrials.gov.