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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Rotator Cuff Tendinopathy

In brief

The purpose of the present study was 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.

Key facts

Study ID

NCT05758415

Run by

Novartis Pharmaceuticals

People needed

60

Starts

2023-08-02

Expected to finish

2024-12-11

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral rotator cuff tendinopathy with ≥ 6 weeks to ≤ 6 months symptom duration at baseline.
• 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.
• Total WORC percentage score ≤ 40 at the screening and baseline visits.
• 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.
• Refractory to standard of care: non-steroidal anti-inflammatory drug (NSAIDs) course as per local standard practice (if not intolerant or contraindicated) and a course of physiotherapy over a period of 8 weeks.
• Participant agreed to remain on stable NSAID dosage regimen (if not intolerant or having contraindications; NSAID dose was 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).
• 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; anteroposterior (AP) length maximum 10 mm)

You may not qualify if…

• 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.
• Rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibodies positive at screening.
• 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.
• Lack of compliance with adhering to NSAID (unless intolerant or contraindicated) and physiotherapy regimen during run-in period.
• Positive painful arc test result in contralateral shoulder
• Inability or unwillingness to undergo MRI of the shoulder (e.g., participants with pacemakers, or metal fragments/foreign objects in the body that were not compatible with performing an MRI) to fulfill eligibility criteria (unless centrally read MRI images acquired within 3 months of baseline could be provided and the quality of images was deemed sufficient).

Where it is running

• Horizon Clinical Research — La Mesa, California, United States
• Medvin Clinical Research — Van Nuys, California, United States
• Conquest Research — Winter Park, Florida, United States
• LV Research — Las Vegas, Nevada, United States
• Novartis Investigative Site — Wuhan, CHN, China
• Novartis Investigative Site — Shijiazhuang, Hebei, China
• Novartis Investigative Site — Wuhan, Hubei, China
• Novartis Investigative Site — Xian, Shanxi, China
• Novartis Investigative Site — Chengdu, Sichuan, China
• Novartis Investigative Site — Shanghai, China
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Siena, SI, Italy
• Novartis Investigative Site — Krakow, Poland
• Novartis Investigative Site — Swidnica, Poland
• Novartis Investigative Site — Torun, Poland
• Novartis Investigative Site — Warsaw, Poland
• Novartis Investigative Site — Warsaw, Poland
• Novartis Investigative Site — Santiago, A Coruna, Spain
• Novartis Investigative Site — Sabadell, Barcelona, Spain
• Novartis Investigative Site — A Coruña, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Valencia, Spain
• Novartis Investigative Site — Bangkok, Thailand
• Novartis Investigative Site — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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