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New drug aimed at shoulder pain fails to complete trial

NCT ID NCT05758415

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug secukinumab against a placebo in 60 adults with moderate to severe rotator cuff tendinopathy, a painful shoulder condition. The goal was to see if secukinumab could improve symptoms and shoulder function over 24 weeks. However, the trial was terminated early, so its findings are limited.

What this could mean

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

Active substance
secukinumab
What this could lead to
If successful, secukinumab could offer a new treatment option to reduce pain and improve shoulder function in people with rotator cuff tendinopathy.
What could go wrong
The trial was terminated early with only 60 participants, so results are limited. As a phase 3 study, it may still fail to show benefit or have side effects like infections.

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

60 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

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Horizon Clinical Research

    La Mesa, California, 91942, United States

  • LV Research

    Las Vegas, Nevada, 89119, United States

  • Medvin Clinical Research

    Van Nuys, California, 91405, United States

  • Novartis Investigative Site

    Wuhan, CHN, 430033, China

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050051, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Xian, Shanxi, 710004, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Shanghai, 200040, China

  • Novartis Investigative Site

    Milan, MI, 20157, Italy

  • Novartis Investigative Site

    Siena, SI, 53100, Italy

  • Novartis Investigative Site

    Krakow, 31-141, Poland

  • Novartis Investigative Site

    Swidnica, 85-100, Poland

  • Novartis Investigative Site

    Torun, 87-100, Poland

  • Novartis Investigative Site

    Warsaw, 00-874, Poland

  • Novartis Investigative Site

    Warsaw, 02-677, Poland

  • Novartis Investigative Site

    Santiago, A Coruna, 15705, Spain

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Valencia, 46024, Spain

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

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