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

NCT05722522 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: CAIN457O123012022-502068-19-00
• Study Type: interventional
• Target: 33
• Locations: 7 countries
• Sites: 15

Brief Summary

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.

Conditions

Rotator Cuff Tendinopathy

Keywords

Moderate to Severe Rotator Cuff Tendinopathy; Adult; Unilateral; Refractory to standard of care

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) Score at Week 16

  The WORC PSD is a sub-domain of the WORC Patient-Reported Outcome (PRO) and comprises 6 questions that capture the key symptoms experienced by participants with rotator cuff tendinopathy (RCT) relating to pain, weakness, stiffness, and mechanical symptoms. The raw score was converted to a scale of 0 to 100, where 0 represents the most symptomatic score, and 100 represents no symptoms.

  At Week 16

Secondary Outcomes (10)

• Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity Score

  At Week 16

• Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 16

  At Week 16

• Percentage of Participants Who Achieved an Improvement (Increase) of at Least 50 Points From Baseline in the WORC Total Score

  At Week 16

• Percentage of Participants Who Achieved an Improvement (Increase) of at Least 40 Points From Baseline in the WORC PSD Score at Week 24

  At Week 24

• Change From Baseline in WORC PSD Score at Week 24

  At Week 24

Study Arms (2)

Secukinumab

EXPERIMENTAL

Participants received secukinumab 300 mg at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.

Drug: Secukinumab

Placebo

PLACEBO COMPARATOR

Participants received placebo at randomization (baseline visit) and Weeks 1, 2, 3, 4, 8, and 12.

Drug: Placebo

Interventions

Placebo DRUG

2 X placebo / 1 mL as solution for s.c. injection

Placebo

Secukinumab DRUG

2 X secukinumab 150 mg / 1 mL as solution for subcutaneous (s.c.) injection

Also known as: AIN457

Secukinumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Millennium Clinical Trials

Westlake Village, California, 91361, United States

Location

Healthy Life Research

Miami, Florida, 33184, United States

Location

IRIS Research and Development

Plantation, Florida, 33324, United States

Location

Precision Clinical Research LLC

Sunrise, Florida, 33351, United States

Location

West Clinical Research

Morehead City, North Carolina, 28557, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Novartis Investigative Site

San Miguel Tucuman, Tucumán Province, 4000, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1114AAP, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, 4000, Argentina

Location

Novartis Investigative Site

Sofia, 1336, Bulgaria

Location

Novartis Investigative Site

Québec, Quebec, G1V 3M7, Canada

Location

Novartis Investigative Site

Brno, Czech Republic, 66250, Czechia

Location

Novartis Investigative Site

Kolín, 280 02, Czechia

Location

Novartis Investigative Site

Kota Kinabalu, Sabah, 88300, Malaysia

Location

Novartis Investigative Site

Ponte de Lima, 4990-041, Portugal

Location

MeSH Terms

Interventions

secukinumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator, site personnel, persons performing the assessments and participants remained blinded through the Week 24 final database lock. The Novartis clinical trial and submission teams remained blinded to the identity of the treatment from the time of randomization until the Week 16 database lock (for the primary endpoint analysis). The following methods were utilized for blinding: (1) Randomization data were kept strictly confidential until the time of unblinding and were not accessible by anyone else involved in the study with the following exceptions: bioanalyst; (2) the identity of the treatments was concealed by the use of study treatments that were all identical in packaging, labeling, schedule of administration, and appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 10, 2023
• Study Start: August 10, 2023
• Primary Completion: October 17, 2024
• Study Completion: December 13, 2024
• Last Updated: March 24, 2026
• Results First Posted: December 2, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AR (3); CZ (2); MY (1); CA (1); BU (1); PT (1); US (6)