Overview

Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy

Status:
Not yet recruiting
Trial end date:
2025-01-28
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the present study is to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in participants with moderate to severe rotator cuff tendinopathy (RCT), using a randomized, double-blind, placebo controlled, parallel group design to minimize bias.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
Inclusion Criteria:

1. Unilateral rotator cuff tendinopathy with ≥ 6 weeks to ≤ 6 months symptom duration at
BSL.

2. Nocturnal pain in shoulder on at least 3 out of 7 nights in the week prior to Baseline
or "positive painful arc test" on examination.

3. Total WORC percentage score ≤ 40 at the Screening and Baseline visits.

4. Average weekly (i.e., the average of the 7 scores taken once a day) numerical rating
scale (NRS) pain score of ≥5 during the past 7 days prior to the Baseline visit.

5. Refractory to standard of care: NSAIDs course as per local standard practice (if not
intolerant or contraindicated) and a course of physiotherapy over a period of 8 weeks.

6. Participant must agree to remain on stable NSAID dosage regimen (if not intolerant or
having contraindications; NSAID dose is permitted to be reduced, but not increased
above dose established at run-in) and physiotherapy regimen from run-in period until
End of Study (EOS).

7. Presence of tendinopathy in the affected shoulder on a centrally read MRI (Magnetic
Resonance Imaging), with the following conditions: with no tear or partial tear
(maximum 50% tendon thickness; AP length maximum 10 mm).

Exclusion Criteria:

1. Rheumatological and non-rheumatological inflammatory diseases, including but not
limited to polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), axial
spondyloarthritis (AS: Ankylosing Spondylitis, nr-axSpA: non-radiographic Axial
Spondyloarthritis), psoriasis (PsO), and rheumatoid arthritis (RA); fibromyalgia or
severe pain disorder unrelated to the target shoulder; gout; and systemic lupus
erythematosus.

2. Rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibodies
positive at Screening.

3. Oral, intramuscular or intravenous (i.v.) corticosteroid treatment within the last 12
weeks prior to randomization, or presence of any condition that might require
intermittent corticosteroid use.

4. Lack of compliance with adhering to NSAID (unless intolerant or contraindicated) and
physiotherapy regimen during run-in period.

5. Positive painful arc test result in contralateral shoulder.

6. Inability or unwillingness to undergo MRI of the shoulder (e.g., participants with
pacemakers, or metal fragments/foreign objects in the body that are not compatible
with performing an MRI) to fulfill eligibility criteria (unless centrally read MRI
images acquired within 3 months of Baseline can be provided and the quality of images
is deemed sufficient).