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A study to evaluate the effectiveness and safety of AZD1163 in adults with moderate to severe rheumatoid arthritis

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What is this trial about?

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

This study investigates the efficacy and safety of a drug named AZD1163 in individuals living with Rheumatoid Arthritis. Rheumatoid Arthritis is a type of autoimmune disease where the body's immune system mistakenly attacks the joints, causing swelling, pain, and stiffness. The research aims to see how well this new medication works compared to a placebo.

During the study, participants will receive either AZD1163 or a placebo through a subcutaneous injection, which is a method of delivering medicine into the fatty tissue just below the skin. This is a double-blind study, meaning that neither the participants nor the researchers will know which specific treatment is being administered until the study is completed. Participants will be divided into different groups to compare the effects of the active drug against the inactive substance.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and medication administration

    You will receive either the test drug, called azd1163, or a placebo, which is a substance with no active medicine.

    The azd1163 is provided as a solution for injection and is administered through a subcutaneous use, which means the injection is given into the fatty tissue just under the skin.

    The duration of the administration period is monitored to evaluate how the drug affects rheumatoid arthritis, a condition involving inflammation in the joints.

  2. Step 2

    Monitoring and assessment

    At week 12, changes in disease activity will be measured using specific scores to see how much the symptoms and inflammation have changed from the start of the study.

    The effectiveness of the treatment is also tracked by checking if certain response criteria are met, which look at improvements in joint swelling and pain.

    Blood samples may be taken to measure the concentration of the drug in the serum, which is the clear part of the blood left after clotting, and to check for the presence of antibodies, which are proteins the body may produce in response to the medicine.

Who can join the trial?

7 criteria

  • You must have been diagnosed with adult-onset rheumatoid arthritis, which is a type of long-term swelling and pain in the joints that starts in adulthood, for at least 12 weeks before the study begins.
  • Your disease must be moderately-to-severely active, meaning you have at least 6 swollen joints and 6 painful joints, and your CRP (a blood test that shows if there is inflammation or swelling in your body) is higher than the normal range.
  • You must test positive for ACPA, which is a specific type of antibody (a protein in the blood that helps the immune system) often found in people with this condition.
  • You must have a history of not getting enough help from, or having a bad reaction to, csDMARDs (traditional medicines used to slow down the disease) or TNFi (a specific type of medicine that targets inflammation).
  • You must have been taking csDMARDs or SC TNFi (medicine given by injection under the skin) for at least 12 weeks, and your dose must have stayed the same for at least 4 weeks before being assigned to a study group.
  • The study is open to both males and females.
  • You must fall within the specific age range required for this study.

Who cannot join the trial?

4 criteria

  • You cannot participate if you have a history or evidence of a different autoimmune condition, which is a disease where your body's immune system mistakenly attacks your own healthy cells, if it could make it difficult to correctly diagnose rheumatoid arthritis.
  • People who have rheumatoid arthritis along with secondary Sjogren’s disease, a condition that causes dry eyes and mouth, are still allowed to join the study.
  • You cannot participate if you have taken or are planning to take any biologic DMARDs, which are powerful medicines used to slow down the immune system to treat diseases, unless it is a specific type called TNFi.
  • You cannot participate if you are planning to take targeted synthetic DMARDs, which are a specific type of medication designed to interfere with certain parts of the immune system.
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Investigated drugs

AZD1163 is an experimental medication administered as an injection under the skin. This study is testing how well this drug works to treat people with moderate to severe rheumatoid arthritis.

What is already known about the treatment

  • AZD1163

    This medication is an experimental treatment currently being studied in clinical trials and is not yet widely available for general medical use. It is administered as a solution through a small injection under the skin to help manage symptoms of rheumatoid arthritis. This drug works by targeting specific proteins in the body to help calm down an overactive immune system that causes joint inflammation. It is classified as a targeted therapy designed to interrupt the biological processes that lead to autoimmune damage.

  • Placebo

    This is an inactive substance that contains no medicinal ingredients and is used as a control in clinical studies to compare against the active drug. It is typically administered in the same way as the study medication, such as through an injection under the skin, to ensure the trial results are accurate. In this study, it serves no therapeutic purpose for treating rheumatoid arthritis but helps researchers determine if the test drug actually works.

Investigated diseases

Rheumatoid arthritis - This is a chronic condition where the body's immune system mistakenly attacks the lining of the joints. This process causes inflammation that leads to swelling and pain. Over time, the inflammation can cause the joint lining to thicken. This thickening can eventually damage the cartilage and bone within the joint. The condition often affects multiple joints at the same time, frequently starting in the smaller joints of the hands and feet.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522076-85-00Protocol codeD9640C00003Estimated enrolment295 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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