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Study on the Effectiveness and Safety of Secukinumab for Adults with Moderate to Severe Rotator Cuff Tendinopathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called secukinumab on individuals with moderate to severe rotator cuff tendinopathy. Rotator cuff tendinopathy is a condition that affects the shoulder, causing pain and difficulty in movement. The study aims to determine if secukinumab, given as an injection under the skin, is more effective than a placebo in improving shoulder symptoms over a period of 16 weeks.

Participants in the study will receive either secukinumab or a placebo. Secukinumab is a solution for injection that is administered using a pre-filled syringe. The study will last for 24 weeks, during which participants will be monitored for changes in their shoulder symptoms. The main goal is to see if secukinumab can significantly improve physical symptoms compared to the placebo. The study will also assess the safety and tolerability of secukinumab by monitoring any side effects or changes in health indicators.

Throughout the study, participants will have regular check-ups to track their progress and any changes in their condition. The study will also involve the use of MRI scans to confirm the presence of tendinopathy in the shoulder. The results will help determine the effectiveness of secukinumab in treating moderate to severe rotator cuff tendinopathy and provide valuable information on its safety for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, such as having moderate to severe rotator cuff tendinopathy for a duration between 6 weeks and 6 months.

    Participants must have experienced shoulder pain at night on at least 3 out of 7 nights before the baseline visit or have a positive painful arc test.

    An MRI is conducted to confirm the presence of tendinopathy without significant tears.

  2. Step 2

    Baseline assessment

    A baseline assessment is conducted to evaluate the initial condition using the Western Ontario Rotator Cuff Index (WORC) and other measures.

    Participants are required to maintain a stable regimen of NSAIDs and physiotherapy from this point until the end of the study.

  3. Step 3

    Treatment phase

    Participants receive either secukinumab or a placebo. Secukinumab is administered as a 300 mg subcutaneous injection.

    The treatment is given at specified intervals, with serum concentrations measured on Day 1 and Weeks 4 and 16.

  4. Step 4

    Mid-study evaluation

    At Week 16, the primary endpoint is assessed by measuring changes in the WORC Physical Symptom Domain score.

    Secondary endpoints include improvements in other scores and the safety and tolerability of the treatment.

  5. Step 5

    End of study evaluation

    At Week 24, further assessments are conducted to evaluate long-term improvements in shoulder symptoms.

    The study concludes with a final evaluation of safety, including any adverse effects and changes in laboratory parameters.

Who can join the trial?

10 criteria

  • Have **moderate to severe rotator cuff tendinopathy** in one shoulder, with symptoms lasting between 6 weeks and 6 months.
  • Experience **nighttime shoulder pain** on at least 3 out of 7 nights in the week before the study starts, or have a **positive painful arc test** during a physical exam. A painful arc test is a way to check for shoulder pain when lifting the arm.
  • Have a **WORC percentage score** of 40 or less at the screening and start of the study. WORC is a questionnaire that measures shoulder problems.
  • Have an **average pain score** of 5 or more over the past 7 days before the study starts, based on a scale where you rate your pain each day.
  • Have tried standard treatments like **NSAIDs** (non-steroidal anti-inflammatory drugs) and **physiotherapy** for 8 weeks, but still have symptoms. NSAIDs are common pain relievers.
  • Agree to keep the same dose of NSAIDs and continue physiotherapy from the start of the study until the end, unless you can't tolerate them or they are not recommended for you. You can reduce the NSAID dose but not increase it.
  • Have **tendinopathy** in the affected shoulder confirmed by an **MRI** (Magnetic Resonance Imaging) scan, with no tear or only a partial tear of the tendon. A partial tear means the tendon is damaged but not completely torn, with a maximum of 50% thickness affected and a length of up to 10 mm.
  • Be within the age range specified for the study.
  • Both **male and female** participants are eligible.
  • Participants from vulnerable populations can also join the study.

Who cannot join the trial?

10 criteria

  • Participants with any other shoulder condition that could interfere with the study results.
  • Individuals who have had recent shoulder surgery or plan to have shoulder surgery during the study period.
  • People with a history of allergic reactions to the study medication or similar medications.
  • Participants who are currently using other treatments that could affect the study outcomes.
  • Individuals with severe health conditions that could make participation unsafe.
  • Pregnant or breastfeeding women.
  • Participants who are unable to follow the study procedures or attend study visits.
  • Individuals with a history of drug or alcohol abuse that could interfere with the study.
  • People who have participated in another clinical trial recently.
  • Participants with certain infections or immune system disorders.
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Investigated drugs

Secukinumab is a medication used in this clinical trial to treat patients with active rotator cuff tendinopathy. It is designed to help reduce inflammation and improve physical shoulder symptoms in individuals with moderate to severe conditions. The trial aims to demonstrate that secukinumab is more effective than a placebo in improving these symptoms over a period of 16 weeks.

What is already known about the treatment

Secukinumab – Secukinumab is administered as a subcutaneous injection and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating moderate to severe rotator cuff tendinopathy. It is already approved for other conditions, such as psoriasis and ankylosing spondylitis, and is well-documented in medical literature. The main therapeutic indication in this trial is to improve physical shoulder symptoms associated with rotator cuff tendinopathy. Secukinumab works by inhibiting interleukin-17A, a protein involved in inflammatory processes, thereby reducing inflammation and pain. It is classified as a monoclonal antibody used in immunology.

Investigated diseases

Rotator Cuff Tendinopathy – This condition involves inflammation or irritation of the tendons in the shoulder's rotator cuff. It typically results from repetitive overhead activities or acute injury, leading to pain and weakness in the shoulder. As the condition progresses, individuals may experience increased discomfort during shoulder movements, especially when lifting the arm. Over time, the tendons may become more damaged, potentially leading to partial or complete tears. The severity of symptoms can vary, with some people experiencing mild discomfort and others facing significant pain and limited shoulder function. Regular activities such as reaching, lifting, or sleeping on the affected side may become challenging.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502080-38-00Protocol codeCAIN457O12302Estimated enrolment234 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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