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

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 ArcTest" on examination.

• Symptoms had been present for at least 6 weeks but not more than 6 months atBaseline.

• Moderate to severe rotator cuff tendinopathy was demonstrated by all of thefollowing 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 priorto Baseline.

3. Nocturnal pain occurred at least 4 out of the 7 days in the week prior toBaseline.

• Patients had failed at least 8 weeks of conventional therapy prior to Baseline:inadequate response to NSAIDs and/or paracetamol and physiotherapy; or intoleranceto NSAIDs and/or paracetamol.

Exclusion Criteria:

• Greater than 50% partial thickness tear had been established by MRI or ultrasoundduring assessment in the Run-in phase.

• Patients were expected to require glucocorticoid treatment throughout the trialduration at Baseline (e.g., systemic, intramuscular, local injections in shoulder).

• Previous surgery, or plans for surgery, during the study period, in the affectedshoulder.

• Rheumatologic and chronic inflammatory diseases, including but not limited toinflammatory bowel disease, polymyalgia rheumatica (PMR), PsA, axSpA and rheumatoidarthritis (RA), fibromyalgia or - severe pain disorder unrelated to the targetshoulder.

• Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodieswere positive at Screening.

• History of adhesive capsulitis/frozen shoulder or calcification in the tendon (inaffected or contralateral shoulder) had been confirmed clinically or by medicalimaging.

• Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) inaffected or contralateral shoulder had been confirmed by medical imaging.

• Patients had traumatic rupture that would have been considered eligible for surgeryfor repair of cuff tear.

• Neurological conditions including but not limited to cervical radiculopathy, whichin the opinion of the investigator could have explained the patient's symptoms.

• Any intra-articular/subacromial glucocorticoid treatment had occurred within 12weeks prior to Baseline or more than 2 injections for the current tendinopathy.

• Any oral, intramuscular or i.v. glucocorticoid treatment had occurred 12 weeks priorto Baseline or during the current tendinopathy, whichever was longer.

• Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinoloneantibiotics had occurred within 12 weeks prior to Baseline or during the currenttendinopathy, whichever was longer.

• Neuromuscular or primary/secondary muscular deficiency had limited the ability toperform functional measurement (e.g., shoulder strength test).

• Previous hyaluronic injections had occurred within 12 weeks prior to Baseline orduring the current tendinopathy, whichever was longer.