Efficacy and safety study of rosnilimab in moderate to severe rheumatoid arthritis

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    What is this study about?

    This study will evaluate the effectiveness and safety of Rosnilimab in patients with moderate to severe rheumatoid arthritis. Rosnilimab is an antibody that activates the PD-1 receptor, also known as ANB030. Patients will be randomly assigned to receive Rosnilimab or placebo.

    The main aim of the study is to assess changes in the 28-Joint Disease Activity Index based on the concentration of C-reactive protein (DAS28-CRP) after 12 weeks of treatment. DAS28-CRP is a validated tool that assesses disease activity based on the number of painful and swollen joints and the concentration of C-reactive protein in the blood. A reduction in DAS28-CRP indicates an improvement in the patient’s condition.

    This study aims to test whether Rosnilimab is effective and safe in the treatment of rheumatoid arthritis. If the results are promising, this drug could become a new treatment option for patients suffering from this disease.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Anderlecht , Belgium

      Leuven , Belgium

      Antwerp , Belgium

      Bruxelles , Belgium

      Liu00e8ge , Belgium

      Hamburg , Germany

      Debrecen , Hungary

      Debrecen , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Pavia , Italy

      Firenze , Italy

      Roma , Italy

      Toruu0144 , Poland

      Nowa Su00f3l , Poland

      Warsaw , Poland

      Opole , Poland

      Poznau0144 , Poland

      Poznau0144 , Poland

      Poznau0144 , Poland

      Bytom , Poland

      Biau0142ystok , Poland

      Bydgoszcz , Poland

      Warsaw , Poland

      Kou0161ice , Slovakia

      Bilbao , Spain

      Santiago de Compostela , Spain

      Cu00f3rdoba , Spain

      Santiago De Compostela , Spain

      Santiago De Compostela , Spain

      You can join this study in:

      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 likely need to take:

      1. Screening: Patients would first be evaluated to see if they meet the eligibility criteria, which include:
        • Being 18-65 years old
        • Having a diagnosis of moderate to severe rheumatoid arthritis for at least 3 months
        • Currently receiving treatment with 1-2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) at stable doses
        • Previously had inadequate response to, loss of response, or intolerance to at least 1 csDMARD, biologic DMARD, or targeted synthetic DMARD
      2. Randomization: Eligible patients would be randomly assigned to one of four treatment arms:
        • Rosnilimab (also called ANB030, an investigational PD-1 agonist antibody) at dose level 1, 2, or 3, given by subcutaneous (under the skin) injection
        • Placebo
      3. Treatment Period: The trial will evaluate efficacy measures from baseline to Week 12, so treatment likely occurs over approximately 3 months. Exact frequency of dosing is not specified but is likely every few weeks.
      4. Follow-up: Safety and additional efficacy measures are often collected for a period after completing treatment. The total study duration for each participant is not clearly stated but may be up to approximately 6 months based on estimated study completion date.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Rheumatoid Arthritis (RA): RA is an autoimmune disease that causes chronic inflammation of the joints. It occurs when your immune system mistakenly attacks your body’s tissues, primarily affecting the lining of your joints. This leads to painful swelling, stiffness, and over time, can cause joint deformity and bone erosion. RA most commonly affects the joints of the hands, wrists, elbows, knees, ankles, and feet, usually on both sides of the body.

       


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Key Inclusion Criteria:

      1. You must be 18 years of age or older
      2. You must have a diagnosis of Rheumatoid Arthritis (RA) based on the ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial
        • RA is a chronic inflammatory disorder that primarily affects the joints, causing pain, swelling, and stiffness
        • The ACR/EULAR criteria are a set of guidelines used by doctors to diagnose RA based on symptoms, blood tests, and imaging results
      3. You must be receiving treatment with at least 1, but not more than 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for at least 3 months and be on stable dosages for at least 8 weeks prior to joining and throughout the trial
        • csDMARDs are a class of medications used to slow the progression of RA and prevent joint damage, such as methotrexate, sulfasalazine, and hydroxychloroquine
      4. You must have had an inadequate response to, loss of response, or intolerance to at least 1 csDMARD, biologic DMARD (bDMARD), or targeted synthetic DMARD (tsDMARD) treatment
        • bDMARDs are medications that target specific parts of the immune system involved in RA inflammation, such as TNF inhibitors (e.g., adalimumab, etanercept) and IL-6 inhibitors (e.g., tocilizumab)
        • tsDMARDs are a newer class of medications that target specific molecules inside immune cells, such as JAK inhibitors (e.g., tofacitinib, baricitinib)

      What Reasons Could Exclude Me from the Study?

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

      1. History of an inflammatory joint disease other than Rheumatoid Arthritis: This means if you have had any other type of joint inflammation condition besides RA, such as psoriatic arthritis or lupus arthritis.
      2. Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator: If you have previously been treated with any medication that affects the PD-1 or PD-L1 proteins in your immune system, you are not eligible.
      3. History of cancer within the last 5 years (except for some skin cancers): If you have had most types of cancer in the past 5 years, you cannot participate. Some non-serious skin cancers may be allowed.
      4. Any known or suspected condition that would compromise immune status: If you have a condition or are taking a medication that weakens your immune system, you are not eligible.
      5. Pregnant or breastfeeding women: If you are currently pregnant or breastfeeding, you cannot take part in the study.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The following drugs are involved in this study:

      1. Rosnilimab (ANB030): Rosnilimab is a PD-1 agonist antibody being evaluated as an experimental treatment in this study. It is being given subcutaneously (SC) at 3 different dose levels to patients with moderate to severe rheumatoid arthritis.
      2. Placebo: A placebo is an inactive substance designed to look like the treatment being tested. It is used as a control to compare against the experimental treatment rosnilimab. One group of patients will receive the placebo SC instead of rosnilimab.

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

      Rosnilimab (ANB030) – This is a new, tested substance that is a PD-1 agonist. Rosnilimab is not yet known and used in medicine because it is currently in the clinical trial phase. The clinical trial aims to evaluate the safety and effectiveness of this molecule in the treatment of rheumatoid arthritis.


      Study ID

      CT-EU-00116193

      Recruitment status

      Recruting new patients

      Start of the trial

      10 months ago

      Study phase

      Phase
      II

      Medicinal Product