Trial · NCT05758415
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
NCT05758415, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2025-12-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy. Trials, record NCT05758415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05758415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
- NCT number
- NCT05758415
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Rotator Cuff Tendinopathy
- Interventions
- Secukinumab, Placebo
- First posted
- 2023-03-07
- Last updated
- 2025-12-18
- Results first posted
- 2025-12-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16 | 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. |
| Secondary | Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score | At Week 16 | 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. |
| Secondary | Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 16 | 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. |
| Secondary | Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score | At Week 16 | 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. |
| Secondary | Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 24 | 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. |
| Secondary | Change From Baseline in WORC PSD Score at Week 24 | 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. |
| Secondary | Secukinumab Serum Concentrations | Day 1 and Weeks 4 and 16 | Pharmacokinetic parameters (measures of treatment exposure) were evaluated in all participants, with moderate to severe RCT, treated with secukinumab 300 mg s.c. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum Severity | Up to Week 24 | 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. |
| Secondary | Percentage of Participants With Clinically Significant Changes in Laboratory Parameters | Up to Week 24 | 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. |
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs | Up to Week 24 | Vital signs included sitting systolic blood pressure, sitting diastolic blood pressure, and sitting pulse rate. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16 | At Week 16 | The full analysis set included all participants from the randomized set to whom study treatment was assigned. Number analyzed is the number of participants with available data. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score | At Week 16 | The full analysis set included all participants from the randomized set to whom study treatment was assigned. Number analyzed is the number of participants with available data. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 16 | At Week 16 | The full analysis set included all participants from the randomized set to whom study treatment was assigned. Number analyzed is the number of participants with available data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score | At Week 16 | The full analysis set included all participants from the randomized set to whom study treatment was assigned. Number analyzed is the number of participants with available data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 24 | At Week 24 | The full analysis set included all participants from the randomized set to whom study treatment was assigned. Number analyzed is the number of participants with available data. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in WORC PSD Score at Week 24 | At Week 24 | The full analysis set included all participants from the randomized set to whom study treatment was assigned. Number analyzed is the number of participants with available data. | score on a scale | MEAN |
| SECONDARY | Secukinumab Serum Concentrations | Day 1 and Weeks 4 and 16 | The safety set included all participants who took at least one dose of study treatment during the treatment period. Number analyzed is the number of participants with available data at that timepoint. | μg/mL | MEAN |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum Severity | Up to Week 24 | The safety set included all participants who took at least one dose of study treatment during the treatment period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Significant Changes in Laboratory Parameters | Up to Week 24 | The safety set included all participants who took at least one dose of study treatment during the treatment period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Significant Changes in Vital Signs | Up to Week 24 | The safety set included all participants who took at least one dose of study treatment during the treatment period. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16 | Secukinumab | 30.90 | Standard Deviation 19.250 | score on a scale | |
| Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16 | Placebo | 28.69 | Standard Deviation 27.320 | score on a scale | |
| Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score | Secukinumab | 7.56 | Standard Deviation 6.776 | score on a scale | |
| Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score | Placebo | 8.48 | Standard Deviation 9.744 | score on a scale | |
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 16 | Secukinumab | 28.6 | percentage of participants | ||
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 16 | Placebo | 36.4 | percentage of participants | ||
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score | Secukinumab | 28.6 | percentage of participants | ||
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score | Placebo | 29.2 | percentage of participants | ||
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 24 | Secukinumab | 42.9 | percentage of participants | ||
| Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 24 | Placebo | 33.3 | percentage of participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Secukinumab | 30 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | COMPLETED | Secukinumab | 28 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Secukinumab | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Secukinumab | 0 | 30 | |
| other | COVID-19 | Infections and infestations | Placebo | 2 | 30 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Secukinumab | 0 | 30 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 3 | 30 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Secukinumab | 0 | 30 |
| Total, all-cause mortality | Placebo | 0 | 30 |
| Total, other adverse events | Secukinumab | 0 | 30 |
| Total, other adverse events | Placebo | 4 | 30 |
| Total, serious adverse events | Secukinumab | 0 | 30 |
| Total, serious adverse events | Placebo | 0 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Secukinumab vs Placebo: deaths from any cause | Trial comparisons |
| Secukinumab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05758415
GET https://conductscience.org/api/trials/v1/NCT05758415/results?page=2