Loading clinical trials...

Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, 24-week Study Investigating the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Moderate to Severe Rotator Cuff Tendinopathy and Failure to Conventional Therapy

NCT05569174•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.

Detailed Description

This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase IIIb, 24-week study to investigate the superior efficacy of secukinumab and safety in participants with rotator cuff tendinopathy. Secukinumab 300 mg s.c. was compared to placebo (both arms in combination with patient individualized conventional therapy) in relieving clinical symptoms at Week 24. The study consisted of a screening period up to 6 weeks, a 2-week run-in period, a 12-week treatment period and a 12-week follow-up period. Treatment and follow-up periods were blinded. Participants who met the eligibility criteria at screening continued to the run-in period and were randomized. In the run-in period, participants performed 2 weeks of home-based standardized physiotherapy.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Signed informed consent had to be obtained prior to participation in the study.
•Males and non-pregnant, non-nursing females were between 18 and 65 years of age.
•Rotator cuff tendinopathy (unilateral) was present with a positive "Painful Arc Test" on examination.
•Symptoms had been present for at least 6 weeks but not more than 6 months at Baseline.
•Moderate to severe rotator cuff tendinopathy was demonstrated by all of the following criteria:
•1. WORC score was ≤ 40 at Baseline.
•2. NRS pain score was ≥ 5 at Baseline and for at least 3 days of the 7 days prior to Baseline.
•3. Nocturnal pain occurred at least 4 out of the 7 days in the week prior to Baseline.
•Patients had failed at least 8 weeks of conventional therapy prior to Baseline: inadequate response to NSAIDs and/or paracetamol and physiotherapy; or intolerance to NSAIDs and/or paracetamol.

Exclusion Criteria

•Greater than 50% partial thickness tear had been established by MRI or ultrasound during assessment in the Run-in phase.
•Patients were expected to require glucocorticoid treatment throughout the trial duration at Baseline (e.g., systemic, intramuscular, local injections in shoulder).
•Previous surgery, or plans for surgery, during the study period, in the affected shoulder.
•Rheumatologic and chronic inflammatory diseases, including but not limited to inflammatory bowel disease, polymyalgia rheumatica (PMR), PsA, axSpA and rheumatoid arthritis (RA), fibromyalgia or - severe pain disorder unrelated to the target shoulder.
•Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies were positive at Screening.
•History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) had been confirmed clinically or by medical imaging.
•Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) in affected or contralateral shoulder had been confirmed by medical imaging.
•Patients had traumatic rupture that would have been considered eligible for surgery for repair of cuff tear.
•Neurological conditions including but not limited to cervical radiculopathy, which in the opinion of the investigator could have explained the patient's symptoms.
•Any intra-articular/subacromial glucocorticoid treatment had occurred within 12 weeks prior to Baseline or more than 2 injections for the current tendinopathy.
+4 more criteria

Locations (19)

Novartis Investigative Site

Karlsruhe, Baden-Wurttemberg, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Hanover, Lower Saxony, Germany

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Novartis Investigative Site

Bad Doberan, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Cottbus, Germany

Novartis Investigative Site

Dresden, Germany

Novartis Investigative Site

Erlangen, Germany

Key Dates

Start Date

December 2, 2022

Primary Completion Date

December 18, 2024

Completion Date

December 18, 2024

Last Updated

January 23, 2026

Enrollment

ACTUAL participants

Conditions

Tendinopathy

Interventions

Secukinumab

DRUG

Placebo

OTHER

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

NCT06095050

Shoulder PainTendinopathy+4 more

View study

RECRUITINGNA

Tight Control for Rotator Cuff Tendinopathy

NCT06517680

Rotator Cuff Tendinopathy

View study

RECRUITING

Ultrasonographic Examination of Other Enthesitis Sites in Patients With Lateral Epicondylitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy

Inclusion Criteria

Exclusion Criteria

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Tight Control for Rotator Cuff Tendinopathy

Ultrasonographic Examination of Other Enthesitis Sites in Patients With Lateral Epicondylitis

Assessment of Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) After Effect in Patients With and Without Tennis Elbow (TE)

Ketorolac in Upper Extremity Tendinopathy and Arthropathy

Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.