E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overuse rotator cuff tendinopathy |
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E.1.1.1 | Medical condition in easily understood language |
Shoulder tendon injury due to overuse |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065093 |
E.1.2 | Term | Tendinosis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
- 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 baseline
- The rotator-cuff tendinopathy must have been refractory to standard treatment, including NSAIDs and physiotherapy
Other protocol-defined inclusion criteria may apply. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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) |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Czech Republic |
Germany |
Netherlands |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |