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

Novartis

Status and phase: Completed; Phase 3

Conditions: Tendinopathy

Treatments: Other: Placebo; Drug: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05569174

2022-001516-26 (EudraCT Number)

CAIN457FDE05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Secukinumab

Experimental group

Description:

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

Treatment:

Drug: Secukinumab

Placebo

Placebo Comparator group

Description:

Participants received placebo s.c. for 12 weeks

Treatment:

Other: Placebo