Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy

Last updated: January 22, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Sprains

Tendon Injuries

Treatment

Placebo

secukinumab

Clinical Study ID

NCT05569174
CAIN457FDE05
2022-001516-26
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to investigate the efficacy and safety of AIN457 (secukinumab s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.

  • The study duration will be 24 weeks.

  • The treatment duration will 12 weeks with 12 weeks follow-up.

  • The visit frequency will be weekly until visit 7 and 4-weekly until end of treatment and 4 follow-up visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation in the study.

  2. Males and non-pregnant, non-nursing females between 18 and 65 years of age

  3. Rotator cuff tendinopathy (unilateral) with positive "Painful Arc Test" onexamination

  4. Symptoms present for at least 6 weeks but not more than 6 months at Baseline

  5. Moderate to severe rotator cuff tendinopathy demonstrated by all of the followingcriteria:

  6. WORC score ≤ 40 at Baseline

  7. NRS pain score ≥ 5 at Baseline and at least 3 days of the past 7 days prior toBaseline

  8. Nocturnal pain at least 4 out of past 7 days in the week prior to Baseline

  9. Failure to at least 8 weeks of conventional therapy prior to Baseline: inadequateresponse to NSAIDs and/or paracetamol and physiotherapy; or intolerance to NSAIDsand/or paracetamol

Exclusion

Exclusion Criteria:

  1. Greater than 50% partial thickness tear as established by MRI or ultrasound duringassessment in Run-in phase

  2. Patients who are expected to require glucocorticoid treatment throughout the trialduration at Baseline (e.g., systemic, intramuscular, local injections in shoulder)

  3. Previous surgery, or plans for surgery, during the study period, in the affectedshoulder

  4. Rheumatologic and chronic inflammatory diseases, including but not limited toinflammatory bowel disease, polymyalgia rheumatica (PMR), PsA, axSpA and rheumatoidarthritis (RA), fibromyalgia or severe pain disorder unrelated to the targetshoulder

  5. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodiespositive at Screening

  6. History of adhesive capsulitis/frozen shoulder or calcification in the tendon (inaffected or contralateral shoulder) confirmed clinically or by medical imaging

  7. Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) inaffected or contralateral shoulder confirmed by medical imaging

  8. Patients with traumatic rupture that would be considered eligible for surgery forrepair of cuff tear.

  9. Neurological conditions including but not limited to cervical radiculopathy, whichin the opinion of the investigator may explain the patient's symptoms

  10. Any intra-articular/subacromial glucocorticoid treatment within 12 weeks prior toBaseline or more than 2 injections for the current tendinopathy.

  11. Any oral, intramuscular or i.v. glucocorticoid treatment 12 weeks prior to Baselineor during the current tendinopathy, whichever takes longer

  12. Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinoloneantibiotics within 12 weeks prior to Baseline or during the current tendinopathy,whichever takes longer

  13. Neuromuscular or primary/secondary muscular deficiency which limits the ability toperform functional measurement (e.g., shoulder strength test)

  14. Previous hyaluronic injections within 12 weeks prior to Baseline or during thecurrent tendinopathy, whichever takes longer

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 02, 2022
Estimated Completion Date:
December 18, 2024

Study Description

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase IIIb, 24-week study to investigate the superior efficacy of AIN457/secukinumab and safety in participants with rotator cuff tendinopathy.

Secukinumab 300 mg s.c. will be compared to placebo (both arms in combination with patient individualized conventional therapy) in relieving clinical symptoms at week 24. Approximately 430 participants (215 per treatment group) will be included with a diagnosis of moderate to severe rotator cuff tendinopathy with no tear or partial tear, who are experiencing active disease for at least 6 weeks and no more than 6 months at Baseline and who have failed to respond to conventional therapy.

The study consists of a Screening period up to 6 weeks, a 2-week Run-in period, a 12-week Treatment period and a 12-week Follow-up period. Treatment and Follow-up period will be blinded. The Screening period will assess eligibility. Participants who meet the eligibility criteria at Screening will continue to Run-in period and will be randomized. In the Run-in period participants should perform 2 weeks of home-based standardized physiotherapy. The Run-in period is initiated by a telephone visit 14 days prior to Randomization. The study comprises a total of 13 visits.

Eligible participants will be randomized 1:1 to either receive secukinumab 300 mg s.c. or placebo s.c. at Baseline, week 1, 2, 3, 4, 8 and 12 (7 injections in total).

Connect with a study center

  • Novartis Investigative Site

    Muenchen, Bavaria 80809
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hannover, Niedersachsen 30159
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Doberan, 18209
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 10787
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cottbus, 03042
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01069
    Germany

    Site Not Available

  • Novartis Investigative Site

    Eichstatt, 85072
    Germany

    Site Not Available

  • Novartis Investigative Site

    Eichstätt, 85072
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt am Main, 60313
    Germany

    Site Not Available

  • Novartis Investigative Site

    Giessen, 35392
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gladbeck, 45968
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gommern, 39245
    Germany

    Site Not Available

  • Novartis Investigative Site

    Greifswald, 17475
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle S, 06120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle Saale, 06120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22415
    Germany

    Site Not Available

  • Novartis Investigative Site

    Heinsberg, 52525
    Germany

    Site Not Available

  • Novartis Investigative Site

    Herne, 44649
    Germany

    Site Not Available

  • Novartis Investigative Site

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg, 39110
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, 55131
    Germany

    Site Not Available

  • Novartis Investigative Site

    Oldenburg In Holstein, 23758
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ravensburg, 88214
    Germany

    Site Not Available

  • Novartis Investigative Site

    Reinfeld, 23858
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schoenebeck, 39218
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wertheim, 97877
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuerzburg, 97074
    Germany

    Site Not Available

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