Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy
Condition: Tendinopathy
MeSH terms: Tendinopathy
Intervention: secukinumab; Placebo
Intervention description: AIN457 300 mg subcutaneously for 12 weeks; Placebo to match AIN457 subcutaneously for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Patients and investigators were blinded until EOS. Sponsor was blinded until after the analysis of the primary endpoint at week 14.
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Overuse tendinopathy; shoulder; rotator cuff; IL-17A-Ab; AIN457X

Summary:

      This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c.
      secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without
      systemic inflammatory disease.
    

Eligibility criteria:

        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

        -