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

NCT05569174 | Completed Phase 3 Results

• 2 other identifiers: CAIN457FDE052022-001516-26
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Tendinopathy

Keywords

shoulder; rotator cuff; IL-17A-Ab; AIN457X; Impingement syndrome

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24

  The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a visual analogue scale (VAS) ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Thus, the total score ranged from 0 to 2100 points. The score was reported as a percentage of normal by subtracting the total score from 2100, dividing by 2100, and multiplying by 100. Total final WORC percentage scores ranged from 0%, the lowest functional status level, to 100%, the highest functional status level. Change from baseline in the WORC percentage total score was assessed at Week 24. A positive change from baseline indicated an improvement.

  Baseline, Week 24

Secondary Outcomes (7)

• Change From Baseline in the WORC Percentage Sub-scores at Week 24

  Baseline, Week 24

• Change From Baseline in Participant's Global Assessment of Disease Activity Score at Week 24

  Baseline, Week 24

• Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24

  Baseline, Week 24

• Change From Baseline in Quick Disability of the Arm, Shoulder and Hand (DASH) Questionnaire Score at Week 24

  Baseline, Week 24

• Change From Baseline in the Numeric Rating Scale (NRS) Pain Score at Week 24

  Baseline, Week 24

Study Arms (2)

Secukinumab

EXPERIMENTAL

Participants received 300 mg of secukinumab s.c. for 12 weeks

Drug: Secukinumab

Placebo

PLACEBO COMPARATOR

Participants received placebo s.c. for 12 weeks

Other: Placebo

Interventions

Secukinumab DRUG

Secukinumab 300 mg s.c for 12 weeks in a pre-filled syringe (PFS)

Also known as: AIN457

Secukinumab

Placebo OTHER

Placebo to match secukinumab s.c. for 12 weeks in a PFS

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• WORC score was ≤ 40 at Baseline.
• NRS pain score was ≥ 5 at Baseline and for at least 3 days of the 7 days prior to Baseline.
• 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.

You may not qualify if:

• 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.
• Any oral, intramuscular or i.v. glucocorticoid treatment had occurred 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.
• Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinolone antibiotics had occurred within 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.
• Neuromuscular or primary/secondary muscular deficiency had limited the ability to perform functional measurement (e.g., shoulder strength test).
• Previous hyaluronic injections had occurred within 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (19)

Novartis Investigative Site

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Novartis Investigative Site

Munich, Bavaria, 80809, Germany

Location

Novartis Investigative Site

Hanover, Lower Saxony, 30159, Germany

Location

Novartis Investigative Site

Halle, Saxony-Anhalt, 06120, Germany

Location

Novartis Investigative Site

Bad Doberan, 18209, Germany

Location

Novartis Investigative Site

Berlin, 10787, Germany

Location

Novartis Investigative Site

Berlin, 12627, Germany

Location

Novartis Investigative Site

Cottbus, 03042, Germany

Location

Novartis Investigative Site

Dresden, 01069, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Frankfurt am Main, 60313, Germany

Location

Novartis Investigative Site

Gladbeck, 45968, Germany

Location

Novartis Investigative Site

Hamburg, 20095, Germany

Location

Novartis Investigative Site

Hamburg, 20149, Germany

Location

Novartis Investigative Site

Hamburg, 22415, Germany

Location

Novartis Investigative Site

Heinsberg, 52525, Germany

Location

Novartis Investigative Site

Herne, 44649, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Schönebeck, 39218, Germany

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Tendinopathy

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@Novartis.com

+1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: December 2, 2022
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: January 23, 2026
• Results First Posted: December 2, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (19)