Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy

This is a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c.
secukinumab 300 mg in approximately 100 randomized patients with overuse rotator-cuff
tendinopathy without systemic inflammatory disease.

The study consists of a 4-week screening period, a 2-week run-in period, a 12-week treatment
period and a 12-week follow-up period after last treatment The population will consist of
patients with unilateral overuse (non-systemic inflammatory) shoulder tendinopathy, 18 - 65
years of age.

Safety assessments will include physical examinations, ECGs, vital signs, standard clinical
laboratory evaluations (hematology, blood chemistry, and urinalysis), adverse event and
serious adverse event monitoring.

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female patients 18 to 65 years of age at
randomization

2. Presence of unilateral rotator cuff tendinopathy with:

1. Symptoms present ≥6 weeks, but <12 months prior to randomization

2. 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

3. 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

4. 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 baseline

3. The rotator-cuff tendinopathy must have been refractory to standard treatment,
including NSAIDs and physiotherapy -

Exclusion Criteria:

1. Rheumatologic, inflammatory diseases, including but not limited to: PsA, AS and RA 2.
Previous shoulder surgery in affected shoulder 3. History of adhesive capsulitis/frozen
shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed
by X-Ray, historic X-Rays can be used if performed within 3 months of baseline 4.
Symptomatic osteoarthritis of the shoulder (gleno-humeral, acromioclavicular) (in affected
or contralateral shoulder confirmed by X-Ray, historic X-Rays can be used if performed
within 3 months of baseline 5. Neck conditions, including but not limited to cervical spine
syndrome, which in the opinion of the investigator, may explain the patient's symptoms 6.
Previous platelet rich plasma injections within the last 12 months prior to randomization
7. Previous treatment with any cell-depleting therapies including but not limited to anti-
CD20, investigational agents (e.g. Campath, anti-CD4, anti-CD5, anti-CD3, anti-CD19) 8.
Previous exposure to any biologic immunomodulating agents, including but not limited to
TNFalpha inhibitors (including, but not limited to adalimumab, infliximab), or biologics
targeting IL-17 (including, but not limited to secukinumab, ixekizumab or brodalumab) or
the IL-17 receptor within the last 12 months prior to baseline 9. Any
intraarticular/subacromial corticosteroid treatment within 8 weeks prior to randomization
and more than 3 injections for the current tendinopathy. Oral, intramuscular or i.v.
corticosteroid treatment within the last 12 months prior to randomization