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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-02

Study Completion Date

2024-12-11

Brief Summary

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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.

Detailed Description

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This was a randomized, double-blind, placebo-controlled Phase III study, stratified by tear status (no tear/ partial tear) in participants with moderate to severe rotator cuff tendinopathy (RCT), experiencing active disease from at least 6 weeks to 6 months at baseline, and were refractory to standard of care (non-steroidal anti-inflammatory drug \[NSAIDs\] and course of physiotherapy) over a period of 8 weeks.

The study was terminated due to the project being discontinued in order to prioritize other key programs in the portfolio. Due to the early termination and small sample size, the analysis by tear status stratification was not performed.

The study duration was up to 32 weeks, consisting of a screening period lasting up to 8 weeks (inclusive of a mandatory 2-week run-in period), a 16-week treatment period with last dose administered at Week 12, and an 8-week safety follow-up period. The primary endpoint assessment was at Week 16, and the safety follow-up data collection was through to Week 24.

Conditions

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Rotator Cuff Tendinopathy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Secukinumab

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

Group Type EXPERIMENTAL

Secukinumab

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Secukinumab

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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AIN457

Eligibility Criteria

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Inclusion Criteria

1. Unilateral rotator cuff tendinopathy with ≥ 6 weeks to ≤ 6 months symptom duration at baseline.
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: 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.
6. 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).
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; anteroposterior (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 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2022-502080-38-00

Identifier Type: OTHER

Identifier Source: secondary_id

CAIN457O12302

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Secukinumab

Secukinumab

Placebo

Placebo

Interventions

Secukinumab

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Novartis Pharmaceuticals

Responsible Party

Principal Investigators

Novartis Pharmaceuticals

Locations

Horizon Clinical Research

Medvin Clinical Research

Conquest Research

LV Research

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Countries

Provided Documents

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

2022-502080-38-00

CAIN457O12302