A Phase 3 interventional study of Secukinumab and Placebo in Rotator Cuff Tendinopathy, sponsored by Novartis Pharmaceuticals. Terminated at 24 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
This was a randomized, double-blind, placebo-controlled Phase III study, stratified by tear status (no tear/ partial tear) in participants with moderate to severe rotator cuff tendinopathy (RCT), experiencing active disease from at least 6 weeks to 6 months at baseline, and were refractory to standard of care (non-steroidal anti-inflammatory drug [NSAIDs] and course of physiotherapy) over a period of 8 weeks.
The study was terminated due to the project being discontinued in order to prioritize other key programs in the portfolio. Due to the early termination and small sample size, the analysis by tear status stratification was not performed.
The study duration was up to 32 weeks, consisting of a screening period lasting up to 8 weeks (inclusive of a mandatory 2-week run-in period), a 16-week treatment period with last dose administered at Week 12, and an 8-week safety follow-up period. The primary endpoint assessment was at Week 16, and the safety follow-up data collection was through to Week 24.
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Exclusion Criteria:
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
Drug: Secukinumab
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
Drug: Placebo
2 X secukinumab 150 mg / 1 mL as solution for subcutaneous (s.c.) injection
Also known as: AIN457
2 X placebo / 1 mL as solution for s.c. injection
Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16
The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
Time frame: At Week 16
Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score
PROMIS-SF Upper Extremity measures self-reported capability of physical function. Participants were asked a series of 7 questions rating their ability to perform a range of physical activities related to daily life that would be impacted by shoulder function. Each response was scored from 1 (unable to do) to 5 (without any difficulty). The responses for the 7 questions were added to the total raw score ranging from 7 (worst) to 35 (best) and converted to a T-score with a range from 16.3 (worst outcome) to 58.2 (best outcome), which was used for the analysis. Therefore, the theoretical range for the value for change from baseline for converted T-scores was between -41.9 to 41.9. A positive change from baseline indicated a better outcome.
Time frame: At Week 16
Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 16
The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
Time frame: At Week 16
Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score
The WORC is a patient-reported outcome tool, uniquely developed for rotator cuff conditions. The WORC is self-administered and consists of 21 items divided into five domains: physical symptoms, sport/recreation, work function, lifestyle function, and emotional function. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
Time frame: At Week 16
Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 24
The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
Time frame: At Week 24
Change From Baseline in WORC PSD Score at Week 24
The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
Time frame: At Week 24
Secukinumab Serum Concentrations
Pharmacokinetic parameters (measures of treatment exposure) were evaluated in all participants, with moderate to severe RCT, treated with secukinumab 300 mg s.c.
Time frame: Day 1 and Weeks 4 and 16
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum Severity
Severity: Mild - usually transient in nature and generally not interfering with normal activities; Moderate - sufficiently discomforting to interfere with normal activities; Severe - prevents normal activities.
Time frame: Up to Week 24
Percentage of Participants With Clinically Significant Changes in Laboratory Parameters
Laboratory parameters included alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, albumin, amylase, calcium, creatinine, bilirubin, glucose, lactate dehydrogenase, lipase, magnesium, phosphate, potassium, sodium, urate, and urea nitrogen.
Time frame: Up to Week 24
Percentage of Participants With Clinically Significant Changes in Vital Signs
Vital signs included sitting systolic blood pressure, sitting diastolic blood pressure, and sitting pulse rate.
Time frame: Up to Week 24
Percentage of Participants With Binding and Neutralizing Anti-drug Antibodies
Time frame: At Day 1 and Week 16
| Milestone | Secukinumab | Placebo |
|---|---|---|
| Started | 30 | 30 |
| Completed | 28 | 24 |
| Not completed | 2 | 6 |
| Withdrew: Subject decision | 2 | 5 |
| Withdrew: Lost to follow-up | 0 | 1 |
The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
| score on a scale | Secukinumab | Placebo |
|---|---|---|
| Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16 | 30.90 ± 19.250 | 28.69 ± 27.320 |
PROMIS-SF Upper Extremity measures self-reported capability of physical function. Participants were asked a series of 7 questions rating their ability to perform a range of physical activities related to daily life that would be impacted by shoulder function. Each response was scored from 1 (unable to do) to 5 (without any difficulty). The responses for the 7 questions were added to the total raw score ranging from 7 (worst) to 35 (best) and converted to a T-score with a range from 16.3 (worst outcome) to 58.2 (best outcome), which was used for the analysis. Therefore, the theoretical range for the value for change from baseline for converted T-scores was between -41.9 to 41.9. A positive change from baseline indicated a better outcome.
| score on a scale | Secukinumab | Placebo |
|---|---|---|
| Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score | 7.56 ± 6.776 | 8.48 ± 9.744 |
The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
| percentage of participants | Secukinumab | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 16 | 28.6 | 36.4 |
The WORC is a patient-reported outcome tool, uniquely developed for rotator cuff conditions. The WORC is self-administered and consists of 21 items divided into five domains: physical symptoms, sport/recreation, work function, lifestyle function, and emotional function. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
| percentage of participants | Secukinumab | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score | 28.6 | 29.2 |
The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
| percentage of participants | Secukinumab | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 24 | 42.9 | 33.3 |
The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.
| score on a scale | Secukinumab | Placebo |
|---|---|---|
| Change From Baseline in WORC PSD Score at Week 24 | 35.79 ± 21.374 | 27.36 ± 27.663 |
Pharmacokinetic parameters (measures of treatment exposure) were evaluated in all participants, with moderate to severe RCT, treated with secukinumab 300 mg s.c.
| μg/mL | Secukinumab |
|---|---|
| Day 1 | 0.00 ± 0.00 |
| Week 4 | 90.5 ± 34.5 |
| Week 16 | 41.8 ± 18.1 |
Severity: Mild - usually transient in nature and generally not interfering with normal activities; Moderate - sufficiently discomforting to interfere with normal activities; Severe - prevents normal activities.
| percentage of participants | Secukinumab | Placebo |
|---|---|---|
| Mild | 20.0 | 26.7 |
| Moderate | 10.0 | 10.0 |
| Severe | 0 | 3.3 |
Laboratory parameters included alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, albumin, amylase, calcium, creatinine, bilirubin, glucose, lactate dehydrogenase, lipase, magnesium, phosphate, potassium, sodium, urate, and urea nitrogen.
| percentage of participants | Secukinumab | Placebo |
|---|---|---|
| Percentage of Participants With Clinically Significant Changes in Laboratory Parameters | 0 | 0 |
Vital signs included sitting systolic blood pressure, sitting diastolic blood pressure, and sitting pulse rate.
| percentage of participants | Secukinumab | Placebo |
|---|---|---|
| Percentage of Participants With Clinically Significant Changes in Vital Signs | 0 | 0 |
| percentage of participants | Secukinumab | Placebo |
|---|---|---|
| Day 1 | 0 | 0 |
| Week 16 | 0 | 0 |
Collected over Adverse events were reported up to a maximum duration of 24 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Secukinumab | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Placebo | 0/30 (0%) | 0/30 (0%) | 4/30 (13.3%) |
| Event | Secukinumab | Placebo |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/30 | 3/30 |
| COVID-19Infections and infestations | 0/30 | 2/30 |
The randomized set included all participants who were randomized.
| Age, Continuous(years) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Mean | 47.5 ± 9.74 | 49.5 ± 9.62 | 48.5 ± 9.65 |
| Age, Customized(participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| 25 - < 45 years | 13 | 9 | 22 |
| 45 - <= 65 years | 17 | 21 | 38 |
| Sex: Female, Male(Participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 13 | 12 | 25 |
| Race/Ethnicity, Customized(participants) | Secukinumab | Placebo | Total |
|---|---|---|---|
| White | 19 | 24 | 43 |
| Black or African American | 1 | 0 | 1 |
| Asian | 10 | 5 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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