Trial Outcomes & Findings for Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy (NCT NCT05758415)
NCT ID: NCT05758415
Last Updated: 2025-12-18
Results Overview
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.
TERMINATED
PHASE3
60 participants
At Week 16
2025-12-18
Participant Flow
272 participants were screened in this study, of which 212 discontinued prior to randomization.
Participant milestones
| Measure |
Secukinumab
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Secukinumab
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Overall Study
Subject Decision
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
Baseline characteristics by cohort
| Measure |
Secukinumab
n=30 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=30 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 9.74 • n=47 Participants
|
49.5 years
STANDARD_DEVIATION 9.62 • n=41 Participants
|
48.5 years
STANDARD_DEVIATION 9.65 • n=88 Participants
|
|
Age, Customized
25 - < 45 years
|
13 participants
n=47 Participants
|
9 participants
n=41 Participants
|
22 participants
n=88 Participants
|
|
Age, Customized
45 - <= 65 years
|
17 participants
n=47 Participants
|
21 participants
n=41 Participants
|
38 participants
n=88 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=47 Participants
|
18 Participants
n=41 Participants
|
35 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=47 Participants
|
12 Participants
n=41 Participants
|
25 Participants
n=88 Participants
|
|
Race/Ethnicity, Customized
White
|
19 participants
n=47 Participants
|
24 participants
n=41 Participants
|
43 participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=47 Participants
|
0 participants
n=41 Participants
|
1 participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=47 Participants
|
5 participants
n=41 Participants
|
15 participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=47 Participants
|
1 participants
n=41 Participants
|
1 participants
n=88 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: 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.
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.
Outcome measures
| Measure |
Secukinumab
n=21 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=22 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16
|
30.90 score on a scale
Standard Deviation 19.250
|
28.69 score on a scale
Standard Deviation 27.320
|
SECONDARY outcome
Timeframe: At Week 16Population: 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.
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.
Outcome measures
| Measure |
Secukinumab
n=28 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=23 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score
|
7.56 score on a scale
Standard Deviation 6.776
|
8.48 score on a scale
Standard Deviation 9.744
|
SECONDARY outcome
Timeframe: At Week 16Population: 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.
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.
Outcome measures
| Measure |
Secukinumab
n=21 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=22 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
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 percentage of participants
|
36.4 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: 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.
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.
Outcome measures
| Measure |
Secukinumab
n=28 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=24 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
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
|
29.2 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 24Population: 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.
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.
Outcome measures
| Measure |
Secukinumab
n=21 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=21 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
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 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 24Population: 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.
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.
Outcome measures
| Measure |
Secukinumab
n=21 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=21 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Change From Baseline in WORC PSD Score at Week 24
|
35.79 score on a scale
Standard Deviation 21.374
|
27.36 score on a scale
Standard Deviation 27.663
|
SECONDARY outcome
Timeframe: Day 1 and Weeks 4 and 16Population: 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.
Pharmacokinetic parameters (measures of treatment exposure) were evaluated in all participants, with moderate to severe RCT, treated with secukinumab 300 mg s.c.
Outcome measures
| Measure |
Secukinumab
n=29 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Secukinumab Serum Concentrations
Day 1
|
0.00 μg/mL
Standard Deviation 0.00
|
—
|
|
Secukinumab Serum Concentrations
Week 4
|
90.5 μg/mL
Standard Deviation 34.5
|
—
|
|
Secukinumab Serum Concentrations
Week 16
|
41.8 μg/mL
Standard Deviation 18.1
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The safety set included all participants who took at least one dose of study treatment during the treatment period.
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.
Outcome measures
| Measure |
Secukinumab
n=30 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=30 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum Severity
Mild
|
20.0 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum Severity
Moderate
|
10.0 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum Severity
Severe
|
0 percentage of participants
|
3.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The safety set included all participants who took at least one dose of study treatment during the treatment period.
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.
Outcome measures
| Measure |
Secukinumab
n=30 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=30 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in Laboratory Parameters
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The safety set included all participants who took at least one dose of study treatment during the treatment period.
Vital signs included sitting systolic blood pressure, sitting diastolic blood pressure, and sitting pulse rate.
Outcome measures
| Measure |
Secukinumab
n=30 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=30 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: At Day 1 and Week 16Population: The safety set included all participants who took at least one dose of study treatment during the treatment period.
Outcome measures
| Measure |
Secukinumab
n=30 Participants
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=30 Participants
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Percentage of Participants With Binding and Neutralizing Anti-drug Antibodies
Day 1
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Binding and Neutralizing Anti-drug Antibodies
Week 16
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Secukinumab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Secukinumab
n=30 participants at risk
Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
Placebo
n=30 participants at risk
Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • Adverse events were reported up to a maximum duration of 24 weeks.
|
6.7%
2/30 • Adverse events were reported up to a maximum duration of 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • Adverse events were reported up to a maximum duration of 24 weeks.
|
10.0%
3/30 • Adverse events were reported up to a maximum duration of 24 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER