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

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: NCT05569174

Novartis Reference Number: CAIN457FDE05

Last Update: Jan 06, 2023

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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.

Condition 
Tendinopathy
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Dec 02, 2022
Completion date 
Dec 31, 2024
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug
secukinumab
AIN457 300 mg subcutaneously for 12 weeks
Other
Placebo
Placebo to match AIN457 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 Locations

Germany
Novartis Investigative Site
Recruiting
Berlin, 10787
-
Germany
Novartis Investigative Site
Recruiting
Cottbus, 03042
-
Germany
Novartis Investigative Site
Recruiting
Eichstätt, 85072
-
Germany
Novartis Investigative Site
Recruiting
Halle Saale, 06120
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20095
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22415
-
Germany
Novartis Investigative Site
Recruiting
Karlsruhe, 76133
-
Germany
Novartis Investigative Site
Recruiting
Magdeburg, 39110
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]