Study of a new drug for moderate to severe Rotator Cuff Tendinopathy

Active but not recruiting

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    What is this study about?

    The clinical trial examines the use of secukinumab, a drug, for treating moderate to severe rotator cuff tendinopathy—a shoulder condition characterized by pain and limited movement. The study explores whether secukinumab can improve symptoms and physical function compared to a placebo. Participants will receive either the drug or placebo in addition to standard care, under a randomized, double-blind, and placebo-controlled setup, to ensure the results are unbiased.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Sofia , Bulgaria

      Sofia , Bulgaria

      Brno , Czechia

      Praha , Czechia

      Kolin , Czechia

      Pardubice , Czechia

      Vejle , Denmark

      Orleans , France

      Limoges , France

      Dijon , France

      Le Mans , France

      Nantes Cedex 1 , France

      St-Priest-en-Jarez , France

      Lisboa , Portugal

      Bratislava , Slovakia

      Bratislava , Slovakia

      Dolny Kubin , Slovakia

      Piestany , Slovakia

      London , United Kingdom

      You can join this study in:

      Slovakia: Bratislava, Dolný Kubín, Piešťany.

      Czechia: Brno, Kolín, Pardubice, Praha.

      France: Dijon, Le Mans, Limoges, Nantes Cedex 1, Orléans, St-Priest-en-Jarez.

      Portugal: Lisboa.

      United Kingdom: London.

      Bulgaria: Sofia.

      Denmark: Vejle.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      Based on the information provided about this clinical trial, here are the key steps a patient would need to take to participate:

      1. Screening/Run-in Period (up to 56 days):
        • Assess eligibility to participate in the trial
        • Demonstrate they are refractory to standard of care (NSAIDs and physiotherapy) over 8 weeks
        • 2-week run-in period prior to Baseline visit with stable NSAID intake and standardized physiotherapy
        • Undergo MRI and shoulder x-rays to exclude other shoulder pathologies
      2. Treatment Period (Baseline to Week 16):
        • Randomized at Baseline to receive either secukinumab or placebo
        • Receive subcutaneous injections at Day 1, Weeks 1, 2, 3, 4, 8, and 12
        • Continue stable NSAID therapy and standardized physiotherapy regimen
        • Attend study visits for assessments
      3. Follow-up Period (Weeks 16-24):
        • Attend follow-up visit at Week 24
        • Continue stable NSAID therapy and physiotherapy
        • No additional study drug administered

      The total duration of participation for a patient in this clinical trial is approximately 24 weeks (about 6 months), from initial screening through the final follow-up visit. The treatment period itself is 16 weeks.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Rotator cuff tendinopathy – This condition involves pain and limited movement in the shoulder, caused by damage or irritation to the tendons that help move the shoulder. Common symptoms include discomfort when lifting the arm or performing overhead activities, often impacting daily functions.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      1. Have rotator cuff tendinopathy (inflammation of the tendons in the shoulder) in one shoulder that has lasted between 6 weeks and 6 months
      2. Experience shoulder pain at night on at least 3 out of 7 nights in the week before starting the study, or have a “positive painful arc test” (pain in the shoulder when lifting the arm away from the body) during the screening exam
      3. Score 40% or less on the WORC (Western Ontario Rotator Cuff Index) at screening and baseline visits. The WORC is a questionnaire that measures shoulder pain and function.
      4. Have an average pain score of 5 or higher on a 10-point scale during the 7 days before the baseline visit
      5. Still have symptoms after trying standard treatments like NSAIDs (anti-inflammatory medications) and physical therapy for at least 8 weeks
      6. Agree to stay on the same doses of NSAIDs (unless you can’t take them) and continue the same physical therapy program throughout the study
      7. Have evidence of rotator cuff tendon inflammation on an MRI scan, with either no tear or a partial tear (less than 50% of the tendon thickness torn)

      What Reasons Could Exclude Me from the Study?

      Based on the exclusion criteria, you cannot take part in the study if you have any of the following:

      1. Certain inflammatory diseases, including but not limited to:
        • Polymyalgia rheumatica (PMR): An inflammatory disorder causing muscle pain and stiffness, especially in the shoulders
        • Psoriatic arthritis (PsA): A form of arthritis affecting some people with the skin condition psoriasis
        • Axial spondyloarthritis (AS and nr-axSpA): Inflammatory arthritis primarily affecting the spine and sacroiliac joints
        • Psoriasis (PsO): A skin condition that causes red, itchy scaly patches
        • Rheumatoid arthritis (RA): An autoimmune disorder causing joint inflammation and damage
      2. Other conditions, such as:
        • Fibromyalgia: A condition characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues
        • Severe pain disorder unrelated to the target shoulder
        • Gout: A form of arthritis causing severe pain, redness and tenderness in joints
        • Systemic lupus erythematosus: An autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue
      3. Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibodies at screening. These are antibodies often present in autoimmune disorders like rheumatoid arthritis.
      4. Recent corticosteroid treatment, including oral, intramuscular, or intravenous corticosteroids within the last 12 weeks prior to randomization, or any condition that might require intermittent corticosteroid use.
      5. Non-compliance with the NSAID and physiotherapy regimen during the run-in period, unless NSAIDs are not tolerated or are contraindicated.
      6. Painful arc test positive in the opposite shoulder. The painful arc test assesses for rotator cuff disorders; if positive in the non-target shoulder, you would be excluded.
      7. Inability or unwillingness to undergo an MRI (magnetic resonance imaging) of the shoulder, unless a suitable centrally-read MRI has been done within 3 months of the study’s start.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      1. Secukinumab – This drug is being tested for its potential to treat moderate to severe rotator cuff tendinopathy by reducing inflammation and pain in the shoulder. In this study, it is administered to see if it can improve physical function and alleviate symptoms compared to a placebo.
      2. Placebo – A substance with no active therapeutic effect, used in the study to compare its effects against those of secukinumab to ensure the results obtained are due to the drug and not other factors.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Secukinumab – Known in medical literature, secukinumab is primarily used for treating autoimmune diseases like psoriasis, psoriatic arthritis, and ankylosing spondylitis. It works by targeting and neutralizing interleukin-17A (IL-17A), a protein that plays a key role in inflammation.


      Study ID

      CT-EU-00117215

      Recruitment status

      Active but not recruiting

      Start of the trial

      11 months ago

      Study phase

      Phase
      III

      Medicinal Product