A randomized, double-blind, placebo-controlled, parallel group, Phase II, 24-week study investigating the efficacy, safety and tolerability of AIN457 in patients with active overuse tendinopathy refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections

INTERVENTION: Trade Name: COSENTYX Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: secukinumab CAS Number: 1229022‐83‐6 Current Sponsor code: AIN457 Other descriptive name: SECUKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use CONDITION: Overuse rotator cuff tendinopathy ; MedDRA version: 20.0 Level: LLT Classification code 10065093 Term: Tendinosis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To assess the efficacy of secukinumab 300 mg s.c. vs. placebo in patients with overuse rotator cuff tendinopathy in relieving clinical symptoms at week 14 Primary end point(s): • The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score; ; Secondary Objective: ‐ To assess the efficacy of secukinumab 300 mg s.c. vs. placebo in patients with overuse rotator cuff tendinopathy in relieving symptoms over time; ‐ To assess the structural changes in the rotator cuff tendinopathy over time; ‐ To assess PK/immunogenicity in secukinumab treated patients; ‐ To confirm the safety and tolerability of AIN457 in overuse rotator cuff tendinopathy over time; Timepoint(s) of evaluation of this end point: Week 14; SECONDARY OUTCOME: Secondary end point(s): • WORC score (A) ; • Disability of Arm, Shoulder and Hand Questionnaire (QuickDASH) score (A) ; • American Shoulder and Elbow Surgeons Shoulder Evaluation Form (ASES) score (A) ; • EQ5D‐3L score (A) ; • Pain score using a VAS scale (considering the last 24 hours) (A) ; • Patient global assessment (PGA) score using a VAS scale (considering the last 24 hours) (A) ; • Physician global assessment (PhGA) score using a VAS scale (considering the last 24 hours) (A) ; • MRI Sein score (B) ; • PK/immunogenicity assessment (C) ; • Safety and tolerability assessments over time: Incidence and severity of AEs and SAEs; routine safety laboratory parameters (D) Timepoint(s) of evaluation of this end point: A ‐ Weeks 2, 4, 8, 12, 18 and 24 ; B ‐ Weeks 8, 14 and 24 ; C ‐ Day 1, Weeks 4, 12 and 24 ; D ‐ During the entire study INCLUSION CRITERIA: ‐ Male or non‐pregnant, non‐lactating female patients 18 to 65 years of age at randomization ‐ Presence of unilateral rotator cuff tendinopathy with: a. Symptoms present =6 weeks, but <12 months prior to randomization b. Tendinopathy with no more than a 50% tear as established by ultrasound at screening (historic data acceptable if not older than 3 months) and MRI at baseline: Sein MRI tendinopathy scoring system grade I‐III; with no tear or partial tear [maximum 50% tendon thickness (Bauer tendon thickness score maximum 2); AP length maximum 10 mm (Bauer tendon length score max 2)]. Maximum 50% of patients with partial tear c. Pain in the affected shoulder (at rest or on movement) on at least 3 days out of 7 days in the past week prior to baseline and a score of =4 out of 10 on a VAS pain scale d. Positive “Painful Arc Test” on examination and/or nightly pain in the affected shoulder on at least 4 out of 7 days in the past week prior to