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New drug could ease stubborn shoulder pain

NCT ID NCT05569174

Symptom relief Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether secukinumab, an anti-inflammatory drug, can reduce pain and improve function in adults with moderate to severe rotator cuff tendinopathy (shoulder tendon pain) that didn't get better with standard treatments. 62 participants received either the drug or a placebo for 12 weeks. The main goal was to see if shoulder-related quality of life improved after 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Secukinumab (a drug that targets inflammation)
What this could lead to
If it works, this could provide a new treatment option for people with stubborn shoulder tendon pain that hasn't improved with standard care.
What could go wrong
This is a small, early-phase trial with only 62 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

62 people

The number who actually took part.

Started

Dec 2022

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent had to be obtained prior to participation in the study. * Males and non-pregnant, non-nursing females were between 18 and 65 years of age. * Rotator cuff tendinopathy (unilateral) was present with a positive "Painful Arc Test" on examination. * Symptoms had been present for at least 6 weeks but not more than 6 months at Baseline. * Moderate to severe rotator cuff tendinopathy was demonstrated by all of the following criteria: 1. WORC score was ≤ 40 at Baseline. 2. NRS pain score was ≥ 5 at Baseline and for at least 3 days of the 7 days prior to Baseline. 3. Nocturnal pain occurred at least 4 out of the 7 days in the week prior to Baseline. * Patients had failed 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 had been established by MRI or ultrasound during assessment in the Run-in phase. * Patients were 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 were positive at Screening. * History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) had been confirmed clinically or by medical imaging. * Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) in affected or contralateral shoulder had been confirmed by medical imaging. * Patients had traumatic rupture that would have been 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 could have explained the patient's symptoms. * Any intra-articular/subacromial glucocorticoid treatment had occurred within 12 weeks prior to Baseline or more than 2 injections for the current tendinopathy. * Any oral, intramuscular or i.v. glucocorticoid treatment had occurred 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer. * Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinolone antibiotics had occurred within 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer. * Neuromuscular or primary/secondary muscular deficiency had limited the ability to perform functional measurement (e.g., shoulder strength test). * Previous hyaluronic injections had occurred within 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.

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Conditions

The condition(s) this trial relates to.

disease of the tendon

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tendinopathy

Contacts and locations

Locations

  • Novartis Investigative Site

    Karlsruhe, Baden-Wurttemberg, 76133, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 80809, Germany

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30159, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120, Germany

  • Novartis Investigative Site

    Bad Doberan, 18209, Germany

  • Novartis Investigative Site

    Berlin, 10787, Germany

  • Novartis Investigative Site

    Berlin, 12627, Germany

  • Novartis Investigative Site

    Cottbus, 03042, Germany

  • Novartis Investigative Site

    Dresden, 01069, Germany

  • Novartis Investigative Site

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    Frankfurt am Main, 60313, Germany

  • Novartis Investigative Site

    Gladbeck, 45968, Germany

  • Novartis Investigative Site

    Hamburg, 20095, Germany

  • Novartis Investigative Site

    Hamburg, 20149, Germany

  • Novartis Investigative Site

    Hamburg, 22415, Germany

  • Novartis Investigative Site

    Heinsberg, 52525, Germany

  • Novartis Investigative Site

    Herne, 44649, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Schönebeck, 39218, Germany

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