Overuse rotator cuff tendinopathy MedDRA version: 20.0 Level: LLT Classification code 10065093 Term: Tendinosis System Organ Class: 100000004859
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Rheumatologic, inflammatory diseases, including but not limited to: PsA, AS and RA - Previous shoulder surgery in affected shoulder - 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 - 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 - Neck conditions, including but not limited to cervical spine syndrome, which in the opinion of the investigator, may explain the patient’s symptoms - Previous platelet rich plasma injections within the last 12 months prior to randomization - 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) - 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 - 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 Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 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 ; Primary end point(s): • The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score ; Timepoint(s) of evaluation of this end point: Week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ; 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) | — |
Countries
Czech Republic, Germany, Netherlands, United Kingdom, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed