Last Update: Jan 24, 2024
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, 24-week Study Investigating the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Moderate to Severe Rotator Cuff Tendinopathy and Failure to Conventional Therapy
ClinicalTrials.gov Identifier:
Novartis Reference Number:CAIN457FDE05
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

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).

Tendinopathy
Phase 3
Recruiting
430
Dec 02, 2022
Apr 30, 2025
All
18 Years - 65 Years (Adult, Older Adult)

Interventions

Other

Placebo

Placebo to match AIN457 subcutaneously for 12 weeks
Drug

secukinumab

AIN457 300 mg subcutaneously for 12 weeks

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Males and non-pregnant, non-nursing females between 18 and 65 years of age
Rotator cuff tendinopathy (unilateral) with positive "Painful Arc Test" on examination
Symptoms present for at least 6 weeks but not more than 6 months at Baseline

Moderate to severe rotator cuff tendinopathy demonstrated by all of the following criteria:

WORC score ≤ 40 at Baseline
NRS pain score ≥ 5 at Baseline and at least 3 days of the past 7 days prior to Baseline
Nocturnal pain at least 4 out of past 7 days in the week prior to Baseline
Failure to at least 8 weeks of conventional therapy prior to Baseline: inadequate response to NSAIDs and/or paracetamol and physiotherapy; or intolerance to NSAIDs and/or paracetamol

Exclusion Criteria:

Greater than 50% partial thickness tear as established by MRI or ultrasound during assessment in Run-in phase
Patients who are expected to require glucocorticoid treatment throughout the trial duration at Baseline (e.g., systemic, intramuscular, local injections in shoulder)
Previous surgery, or plans for surgery, during the study period, in the affected shoulder
Rheumatologic and chronic inflammatory diseases, including but not limited to inflammatory bowel disease, polymyalgia rheumatica (PMR), PsA, axSpA and rheumatoid arthritis (RA), fibromyalgia or severe pain disorder unrelated to the target shoulder
Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies positive at Screening
History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed clinically or by medical imaging
Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) in affected or contralateral shoulder confirmed by medical imaging
Patients with traumatic rupture that would be considered eligible for surgery for repair of cuff tear.
Neurological conditions including but not limited to cervical radiculopathy, which in the opinion of the investigator may explain the patient's symptoms
Any intra-articular/subacromial glucocorticoid treatment within 12 weeks prior to Baseline or more than 2 injections for the current tendinopathy.
Any oral, intramuscular or i.v. glucocorticoid treatment 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer
Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinolone antibiotics within 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer
Neuromuscular or primary/secondary muscular deficiency which limits the ability to perform functional measurement (e.g., shoulder strength test)
Previous hyaluronic injections within 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer

Study Location

Novartis Investigative Site

Recruiting

Karlsruhe,76133,Germany

Novartis Investigative Site

Recruiting

Gommern,39245,Germany

Novartis Investigative Site

Recruiting

Muenchen,80331,Germany

Novartis Investigative Site

Recruiting

Berlin,12627,Germany

Novartis Investigative Site

Recruiting

Karlsruhe,76137,Germany

Novartis Investigative Site

Recruiting

Halle Saale,06120,Germany

Novartis Investigative Site

Recruiting

Oldenburg In Holstein,23758,Germany

Novartis Investigative Site

Recruiting

Cottbus,03042,Germany

Novartis Investigative Site

Recruiting

Leipzig,Saxonia,04103,Germany

Novartis Investigative Site

Recruiting

Hamburg,20095,Germany

Novartis Investigative Site

Recruiting

Ravensburg,88214,Germany

Novartis Investigative Site

Recruiting

Dresden,01069,Germany

Novartis Investigative Site

Recruiting

Hamburg,22415,Germany

Novartis Investigative Site

Recruiting

Schoenebeck,39218,Germany

Novartis Investigative Site

Recruiting

Eichstätt,85072,Germany

Novartis Investigative Site

Recruiting

Magdeburg,39110,Germany

Novartis Investigative Site

Recruiting

Heinsberg,52525,Germany

Novartis Investigative Site

Recruiting

Wertheim,97877,Germany

Novartis Investigative Site

Recruiting

Erlangen,91054,Germany

Novartis Investigative Site

Recruiting

Mainz,55131,Germany

Novartis Investigative Site

Recruiting

Bad Doberan,Mecklenburg Vorpommern,18209,Germany

Novartis Investigative Site

Recruiting

Herne,44649,Germany

Novartis Investigative Site

Recruiting

Wuerzburg,97074,Germany

Novartis Investigative Site

Recruiting

Frankfurt am Main,60313,Germany

Novartis Investigative Site

Recruiting

Muenchen,Bavaria,80809,Germany

Novartis Investigative Site

Recruiting

Berlin,10787,Germany

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