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

Last updated: November 17, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Sprains

Tendon Injuries

Treatment

Secukinumab

Placebo

Clinical Study ID

NCT05722522
CAIN457O12301
2022-502068-19-00
2021-002038-18
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Unilateral rotator cuff tendinopathy with ≥ 6 weeks to ≤ 6 months symptom durationat baseline.

  2. Nocturnal pain in shoulder on at least 3 out of 7 nights in the week prior tobaseline 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 ratingscale (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) courseas per local standard practice (if not intolerant or contraindicated) and a courseof physiotherapy over a period of 8 weeks.

  6. Participant agreed to remain on stable NSAID dosage regimen (if not intolerant orhaving contraindications; NSAID dose was permitted to be reduced, but not increasedabove dose established at run-in) and physiotherapy regimen from run-in period untilEnd of Study (EOS).

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

Exclusion

Exclusion Criteria:

  1. Rheumatological and non-rheumatological inflammatory diseases, including but notlimited to polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), axialspondyloarthritis (AS: ankylosing spondylitis, nr-axSpA: non-radiographic axialspondyloarthritis), psoriasis (PsO), and rheumatoid arthritis (RA); fibromyalgia orsevere pain disorder unrelated to the target shoulder; gout; and systemic lupuserythematosus.

  2. Rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibodiespositive 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 requireintermittent corticosteroid use.

  4. Lack of compliance with adhering to NSAID (unless intolerant or contraindicated) andphysiotherapy 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 withpacemakers, or metal fragments/foreign objects in the body that were not compatiblewith performing an MRI) to fulfill eligibility criteria (unless centrally read MRIimages acquired within 3 months of baseline could be provided and the quality ofimages was deemed sufficient).

Study Design

Total Participants: 33
Treatment Group(s): 2
Primary Treatment: Secukinumab
Phase: 3
Study Start date:
August 10, 2023
Estimated Completion Date:
December 13, 2024

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires C1055AAF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Miguel De Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Miguel Tucuman, Tucumán Province 3833578 4000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires, C1114AAP
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires 3435910, C1114AAP
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Miguel de Tucumán 3836873, 4000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Tucuman, 4000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Sofia, 1632
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Sofia 727011, 1336
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Québec 6325494, Quebec 6115047 G1V 3M7
    Canada

    Site Not Available

  • Novartis Investigative Site

    Quebec, G1V 3M7
    Canada

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  • Novartis Investigative Site

    Santiago, RM 7500588
    Chile

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  • Novartis Investigative Site

    Vitacura, Santiago 7640881
    Chile

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  • Novartis Investigative Site

    Brno, Czech Republic 66250
    Czechia

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    Brno 3078610, Czech Republic 66250
    Czechia

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  • Novartis Investigative Site

    Praha, Czech Republic 19000
    Czechia

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  • Novartis Investigative Site

    Kolin, 280 02
    Czechia

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  • Novartis Investigative Site

    Kolín 3073371, 280 02
    Czechia

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  • Novartis Investigative Site

    Pardubice, 53002
    Czechia

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    Vejle, 7100
    Denmark

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    Orleans, Cedex 2 45067
    France

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    Limoges, Haute Vienne 87000
    France

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    Dijon, 21034
    France

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    Le Mans, 72037
    France

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    Nantes Cedex 1, 44093
    France

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    St-Priest-en-Jarez, 42270
    France

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    Kota Kinabalu, Sabah 88300
    Malaysia

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    Kota Kinabalu 1733432, Sabah 1733039 88300
    Malaysia

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    Kuala Lumpur, 59100
    Malaysia

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    Selangor Darul Ehsan, 68100
    Malaysia

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    Lisboa, 1050-034
    Portugal

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    Ponte de Lima, 4990 041
    Portugal

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    Ponte de Lima 2736041, 4990-041
    Portugal

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    Bratislava, SK-82606
    Slovakia

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    Dolny Kubin, 026 01
    Slovakia

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    Piestany, 92101
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    Bursa, Gorukle 16059
    Turkey

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    Istanbul, TUR 34098
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    Ankara, 06230
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    Izmir, 35040
    Turkey

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    London, SW17 0QT
    United Kingdom

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  • Arizona Research .

    Phoenix, Arizona 85053
    United States

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    Phoenix, Arizona 85018
    United States

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    United States

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    Tucson, Arizona 85712
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  • Tucson Orthopedic Institute PC

    Tucson, Arizona 85712
    United States

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  • Novartis Investigative Site

    El Cajon, California 92020
    United States

    Active - Recruiting

  • TriWest Reserach Associates .

    El Cajon, California 92020
    United States

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    La Mesa, California 91942
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  • Purushotham Akther and Roshan Kotha MD Inc

    La Mesa, California 91942
    United States

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    Westlake Village 5408395, California 5332921 91361
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  • CoastalOrthoandSportsMedofSWFlorida .

    Bradenton, Florida 34209
    United States

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    Bradenton, Florida 34209
    United States

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    Doral, Florida 33166
    United States

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  • Universal Axon Clinical Research

    Doral, Florida 33166
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    Miami, Florida 33184
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    Miami, Florida 33184
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    Miami, Florida 33184
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  • IRIS Research and Development

    Plantation, Florida 33324
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  • Integral Rheumatology and Immunology Specialists IRIS

    Plantation, Florida 33324
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    Plantation, Florida 33324
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    Sunrise, Florida 33351
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    Sunrise, Florida 33351
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    Miami 4164138, Florida 4155751 33184
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  • IRIS Research and Development

    Plantation 4168782, Florida 4155751 33324
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  • Precision Clinical Research LLC

    Sunrise 4174402, Florida 4155751 33351
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    Chicago, Illinois 60607
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  • Novartis Investigative Site

    Chicago, Illinois 60607
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  • Affinity Health Corp

    Oak Brook, Illinois 60523
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    Oak Brook, Illinois 60523
    United States

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  • Novartis Investigative Site

    Saint Louis, Missouri 63141
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  • Sundance Clinical Research LLC

    Saint Louis, Missouri 63141
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  • Inspire Santa Fe Medical Group Rheumatology

    Santa Fe, New Mexico 87505
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  • Novartis Investigative Site

    Santa Fe, New Mexico 87505
    United States

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    Morehead City, North Carolina 28557
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  • West Clinical Research

    Morehead City, North Carolina 28557
    United States

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  • West Clinical Research

    Morehead City 4480153, North Carolina 4482348 28557
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  • Altoona Center for Clin Res .

    Duncansville, Pennsylvania 16635
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    Duncansville, Pennsylvania 16635
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  • Antria Inc .

    Indiana, Pennsylvania 15701
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    Indiana, Pennsylvania 15701
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  • Medical Univ of South Carolina .

    Charleston, South Carolina 29425
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    Charleston, South Carolina 29425
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  • Coastal Carolina Research Center .

    Mount Pleasant, South Carolina 29464
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  • Novartis Investigative Site

    Mount Pleasant, South Carolina 29464
    United States

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  • Novartis Investigative Site

    Jackson, Tennessee 38305
    United States

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  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

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  • West Tennessee Research Institute

    Jackson 4632595, Tennessee 4662168 38305
    United States

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  • Virginia Ispine Physicians PC

    Richmond, Virginia 23238
    United States

    Site Not Available

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