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Trial record 1 of 1 for:    nct05722522
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Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy

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ClinicalTrials.gov Identifier: NCT05722522
Recruitment Status : Recruiting
First Posted : February 10, 2023
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tendinopathy Drug: Secukinumab Drug: Placebo Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigator, site personnel, persons performing the assessments and participants will remain blinded through the Week 24 final database lock. The Novartis clinical trial and submission teams will remain 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 are utilized for blinding: (1) Randomization data are kept strictly confidential until the time of unblinding and will not be accessible by anyone else involved in the study with the following exceptions: bioanalyst; (2) the identity of the treatments will be concealed by the use of study treatments that are all identical in packaging, labeling, schedule of administration, and appearance.
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group, 24 Week, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Active Rotator Cuff Tendinopathy
Actual Study Start Date : August 10, 2023
Estimated Primary Completion Date : November 28, 2024
Estimated Study Completion Date : January 23, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis
Drug Information available for: Secukinumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Secukinumab
  • Name and Strength: 2 X Secukinumab 150 mg / 1 mL
  • Pharmaceutical Dosage Form: Solution for subcutaneous (s.c.) injection
  • Randomized in a 1:1 ratio
 Drug: Secukinumab
The participants will receive Secukinumab 300 mg s.c. at randomization (Baseline visit), Week 1, 2, 3, 4, 8, and 12
Other Name: AIN457
Placebo Comparator: Placebo
  • Name and Strength: 2 X Placebo / 1 mL
  • Pharmaceutical Dosage Form: Solution for subcutaneous (s.c.) injection
  • Randomized in a 1:1 ratio
 Drug: Placebo
The participants will receive placebo s.c. at randomization (Baseline visit), Week 1, 2, 3, 4, 8, and 12


Outcome Measures
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Primary Outcome Measures :
  1. Change from BSL in in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score [ Time Frame: At Week 16 ]

    Improving physical shoulder symptoms in participants with moderate to severe RCT 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 RCT relating to pain, weakness, stiffness, and mechanical symptoms. A score of 0 is the best outcome in terms of physical symptoms and a score of 60 is the worst possible score



Secondary Outcome Measures :
  1. Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in the WORC PSD [ Time Frame: At Week 16 ]
    Achieving a clinically meaningful response in improving physical shoulder symptoms in participants with moderate to severe RCT at Week 16

  2. Proportion of participants who achieve an improvement (increase) of at least 50 points from BSL in the WORC total score [ Time Frame: At Week 16 ]
    Improving symptoms caused by RCT and the associated impact on day-to-day functioning in participants with moderate to severe RCT at Week 16

  3. Change from BSL in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity score [ Time Frame: At Week 16 ]

    Improving physical function in participants with moderate to severe RCT at Week 16.

    PROMIS-SF Upper Extremity measures self-reported capability of Physical Function. Participants will be asked a series of 7 questions rating their ability to perform a range of physical activities related to daily life that would be impacted by shoulder function. Each response is scored from 5 (Without any difficulty) to 1 (Unable to do)


  4. Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in the WORC PSD. Change from BSL in the WORC PSD score [ Time Frame: At Week 24 ]
    Improvement of physical symptoms at Week 24

  5. Secukinumab serum concentrations [ Time Frame: Day 1 and Weeks 4 and 16 ]
    Pharmacokinetic parameters (measures of treatment exposure) will be evaluated in all participants, with moderate to severe RCT, treated with secukinumab 300 mg s.c.

  6. Safety and tolerability of secukinumab [ Time Frame: Up to Week 24 ]
    Evaluate safety and tolerability of 300 mg s.c. secukinumab, in participants with moderate to severe RCT: Adverse Events and Serious Adverse Events (incidence, severity, and relationship with study drug), incidence of clinically significant changes in laboratory parameters and vital signs

  7. Incidence of binding and neutralizing Anti-drug antibodies [ Time Frame: At Day 1 and Week 16 ]
    Evaluate immunogenicity of 300 mg s.c. secukinumab, in participants with moderate to severe RCT


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05722522


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05722522    
Other Study ID Numbers: CAIN457O12301
2021-002038-18 ( EudraCT Number )
First Posted: February 10, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Moderate to Severe Rotator Cuff Tendinopathy
Adult
Unilateral
Refractory to standard of care
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries