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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 purpose of the study is to determine if secukinumab can improve shoulder symptoms better than a placebo. Secukinumab is administered as a solution for injection using a pre-filled syringe.

Participants in the study will receive either secukinumab or a placebo. The study will last for 24 weeks, during which the effects of the treatment on shoulder symptoms will be monitored. The main focus will be on changes in physical symptoms related to the shoulder, assessed at different points throughout the study. Participants will be asked to continue any existing treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy, at a stable dosage and regimen.

The study will also involve monitoring the safety and tolerability of secukinumab, including any side effects or changes in laboratory results. Participants will have their progress evaluated through various assessments, including the Western Ontario Rotator Cuff Index (WORC) and the Patient-Reported Outcomes Measurement Information System (PROMIS). The study aims to provide valuable insights into the potential benefits of secukinumab for individuals with rotator cuff tendinopathy.

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

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as having moderate to severe rotator cuff tendinopathy for a duration between 6 weeks and 6 months.

    You will undergo a physical examination, and your shoulder pain will be assessed. An MRI scan will be conducted to confirm the presence of tendinopathy without significant tears.

  2. Step 2

    Baseline assessment

    At the baseline assessment, your shoulder symptoms will be evaluated using the Western Ontario Rotator Cuff Index (WORC) and a numerical rating scale for pain.

    You will be asked to maintain a stable regimen of non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy, if applicable, throughout the study.

  3. Step 3

    Randomization and treatment

    You will be randomly assigned to receive either the study medication, secukinumab, or a placebo. This is a double-blind study, meaning neither you nor the study team will know which treatment you are receiving.

    If assigned to the secukinumab group, you will receive a 300 mg dose administered subcutaneously (under the skin) at specified intervals.

  4. Step 4

    Follow-up visits

    You will attend follow-up visits at regular intervals, including at weeks 4, 16, and 24. During these visits, your shoulder symptoms and overall health will be monitored.

    Blood samples may be taken to measure secukinumab levels and to check for any side effects or the presence of anti-drug antibodies.

  5. Step 5

    Final assessment

    At the end of the 24-week study period, a final assessment will be conducted to evaluate changes in your shoulder symptoms and overall health.

    The results will help determine the effectiveness and safety of secukinumab in treating rotator cuff tendinopathy.

Who can join the trial?

9 criteria

  • Must have **moderate to severe rotator cuff tendinopathy** in one shoulder. This means the shoulder has been painful and difficult to move for at least 6 weeks but not more than 6 months.
  • Must experience **nighttime shoulder pain** on at least 3 out of 7 nights in the week before starting the study, or have a **positive painful arc test**. This is a test where moving the arm in a certain way causes pain.
  • Must have a **Total WORC percentage score** of 40 or less at the Screening and Baseline visits. WORC is a questionnaire that measures shoulder problems.
  • Must have an **average weekly pain score** of 5 or more on a scale from 0 to 10 during the week before starting the study. This score is based on daily pain ratings.
  • Must have tried standard treatments like **NSAIDs** (non-steroidal anti-inflammatory drugs) and **physiotherapy** for 8 weeks without improvement. NSAIDs are common pain relievers.
  • Must agree to keep the same dose of NSAIDs and continue physiotherapy from the start of the study until the end, unless the doctor advises otherwise.
  • Must have **tendinopathy** in the affected shoulder confirmed by an **MRI** (Magnetic Resonance Imaging) scan. The MRI should show no tear or only a small tear in the tendon.
  • Must be within the age range of 18 to 65 years old.
  • Both **male and female** participants are eligible.

Who cannot join the trial?

10 criteria

  • Patients with any other shoulder condition that is not related to rotator cuff tendinopathy cannot participate. Rotator cuff tendinopathy is a condition that affects the tendons in the shoulder, causing pain and movement problems.
  • Patients who have had shoulder surgery in the past 6 months are not eligible.
  • Patients who are currently receiving treatment with other medications that affect the immune system cannot join the study.
  • Patients with a history of severe allergic reactions to medications are excluded.
  • Patients with any active infection or a history of frequent infections are not allowed to participate.
  • Patients with a history of cancer in the past 5 years, except for certain skin cancers, are excluded.
  • Patients with severe heart, liver, or kidney problems cannot take part in the study.
  • Pregnant or breastfeeding women are not eligible to participate.
  • Patients who are currently participating in another clinical trial are excluded.
  • Patients with a history of drug or alcohol abuse in the past year cannot join the study.
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Investigated drugs

Secukinumab is a medication used in this clinical trial to help improve shoulder symptoms in people with a condition called rotator cuff tendinopathy. This condition causes pain and discomfort in the shoulder due to inflammation or irritation of the tendons. Secukinumab works by targeting a specific protein in the body that is involved in the inflammation process. By reducing inflammation, it can help relieve pain and improve shoulder function. This medication is given as an injection under the skin.

What is already known about the treatment

Secukinumab – Secukinumab is administered as an injection under the skin, known as subcutaneous administration. It is currently being studied in clinical trials for its effectiveness in treating moderate to severe rotator cuff tendinopathy, a condition that causes pain and limited movement in the shoulder. The medication works by targeting and blocking a specific protein in the body called interleukin-17A, which plays a role in inflammation and immune response. Secukinumab is classified as a biologic medication, specifically a monoclonal antibody, and is being evaluated for its potential to improve shoulder symptoms compared to a placebo.

Investigated diseases

Rotator Cuff Tendinopathy – Rotator cuff tendinopathy is a condition affecting the tendons of the rotator cuff in the shoulder. It is characterized by pain and inflammation in the shoulder area, often resulting from overuse or repetitive motion. The condition progresses as the tendons become more irritated and inflamed, leading to increased pain and reduced range of motion. Over time, the tendons may weaken, causing difficulty in performing everyday activities that involve shoulder movement. In more severe cases, the tendons can degenerate, leading to chronic pain and further restriction of shoulder function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502068-19-00Protocol codeCAIN457O12301Estimated enrolment234 patientsSponsorNovartis Pharma AG

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