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Shoulder pain drug trial halted early

NCT ID NCT05722522

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the drug secukinumab could reduce pain and improve function in adults with moderate to severe rotator cuff tendinopathy, a common shoulder condition. Participants received either the drug or a placebo for 24 weeks. The trial was terminated early, and results are limited.

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

33 people

The number who actually took part.

Started

Aug 2023

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Unilateral rotator cuff tendinopathy with ≥ 6 weeks to ≤ 6 months symptom duration at baseline. 2. Nocturnal pain in shoulder on at least 3 out of 7 nights in the week prior to baseline 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 rating scale (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) course as per local standard practice (if not intolerant or contraindicated) and a course of physiotherapy over a period of 8 weeks. 6. Participant agreed to remain on stable NSAID dosage regimen (if not intolerant or having contraindications; NSAID dose was permitted to be reduced, but not increased above dose established at run-in) and physiotherapy regimen from run-in period until End of Study (EOS). 7. Presence of tendinopathy in the affected shoulder on a centrally read MRI (Magnetic Resonance Imaging), with the following conditions: with no tear or partial tear (maximum 50% tendon thickness; anteroposterior (AP) length maximum 10 mm) Exclusion Criteria: 1. Rheumatological and non-rheumatological inflammatory diseases, including but not limited to polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), axial spondyloarthritis (AS: ankylosing spondylitis, nr-axSpA: non-radiographic axial spondyloarthritis), psoriasis (PsO), and rheumatoid arthritis (RA); fibromyalgia or severe pain disorder unrelated to the target shoulder; gout; and systemic lupus erythematosus. 2. Rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibodies positive 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 require intermittent corticosteroid use. 4. Lack of compliance with adhering to NSAID (unless intolerant or contraindicated) and physiotherapy 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 with pacemakers, or metal fragments/foreign objects in the body that were not compatible with performing an MRI) to fulfill eligibility criteria (unless centrally read MRI images acquired within 3 months of baseline could be provided and the quality of images was deemed sufficient).

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Conditions

The condition(s) this trial relates to.

disease of the tendon rotator cuff syndrome

As listed by the trial registrant

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

Rotator cuff tendinopathy

Contacts and locations

Locations

  • Healthy Life Research

    Miami, Florida, 33184, United States

  • IRIS Research and Development

    Plantation, Florida, 33324, United States

  • Millennium Clinical Trials

    Westlake Village, California, 91361, United States

  • Novartis Investigative Site

    San Miguel Tucuman, Tucumán Province, 4000, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1114AAP, Argentina

  • Novartis Investigative Site

    San Miguel de Tucumán, 4000, Argentina

  • Novartis Investigative Site

    Sofia, 1336, Bulgaria

  • Novartis Investigative Site

    Québec, Quebec, G1V 3M7, Canada

  • Novartis Investigative Site

    Brno, Czech Republic, 66250, Czechia

  • Novartis Investigative Site

    Kolín, 280 02, Czechia

  • Novartis Investigative Site

    Kota Kinabalu, Sabah, 88300, Malaysia

  • Novartis Investigative Site

    Ponte de Lima, 4990-041, Portugal

  • Precision Clinical Research LLC

    Sunrise, Florida, 33351, United States

  • West Clinical Research

    Morehead City, North Carolina, 28557, United States

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.