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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-02

Study Completion Date

2024-12-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Secukinumab

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

Group Type EXPERIMENTAL

Secukinumab

Intervention Type DRUG

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

Placebo

Participants received placebo s.c. for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Secukinumab

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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AIN457

Eligibility Criteria

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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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes