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Study on the Effects of IMVT-1402 for Adults with Difficult-to-Treat Rheumatoid Arthritis

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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 Rheumatoid Arthritis, a condition where the immune system mistakenly attacks the joints, causing pain and swelling. The study will test a new treatment called IMVT-1402, which is given as a solution for injection under the skin. The purpose of the study is to evaluate how effective and safe this treatment is for adults with a specific type of rheumatoid arthritis known as ACPA-Positive Rheumatoid Arthritis, which is often difficult to treat.

Participants in the study will receive either the new treatment, IMVT-1402, or a placebo, which looks like the treatment but contains no active substance. The study will be conducted in two periods. During the first period, all participants will receive the treatment. In the second period, some participants will continue with the treatment, while others will receive the placebo. The study will last for several weeks, and participants will be monitored to see how their symptoms change over time.

The main goal is to see how many participants maintain a positive response to the treatment by the end of the study. Additionally, changes in specific scores that measure disease activity will be observed. This study aims to provide more information about the potential benefits and safety of IMVT-1402 for people living with rheumatoid arthritis.

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, an initial visit is conducted to confirm eligibility. This involves a thorough review of medical history and a physical examination.

    Blood tests are performed to measure specific markers related to rheumatoid arthritis, such as ACPA levels and hsCRP levels. ACPA stands for anti-citrullinated protein antibodies, and hsCRP is high-sensitivity C-reactive protein, both of which are indicators of inflammation in the body.

    Joint assessments are conducted to count the number of tender and swollen joints.

  2. Step 2

    Treatment period 1

    Participants receive the study medication, IMVT-1402, or a placebo. The placebo looks like the study medication but does not contain the active substance.

    The medication is administered as a solution for injection under the skin, known as subcutaneous use.

    The dosage and frequency of administration are determined by the study protocol and are explained during this period.

    Regular follow-up visits are scheduled to monitor the response to the treatment and any side effects.

  3. Step 3

    Assessment of response

    The effectiveness of the treatment is evaluated using the ACR20 response criteria, which measures a 20% improvement in tender and swollen joint counts, as well as other symptoms.

    Participants who respond positively to the treatment continue to the next phase of the study.

  4. Step 4

    Treatment period 2

    Participants who continue in the study receive either the study medication or placebo, as per the study design.

    The focus is on maintaining the response achieved in the first treatment period.

    Regular assessments are conducted to monitor changes in disease activity using scores such as CDAI and SDAI, which are clinical and simplified disease activity indices.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation is conducted to assess the overall response to the treatment.

    Participants undergo a comprehensive review, including physical examinations and laboratory tests, to determine the long-term effects and safety of the treatment.

Who can join the trial?

8 criteria

  • Must have a diagnosis of definite Rheumatoid Arthritis (RA) according to the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria.
  • Must have at least 6 tender or painful joints and 6 swollen joints at both the Screening and Baseline visits.
  • Must have a blood test showing high levels of C-reactive protein (hsCRP), which is a marker of inflammation, at the Screening Visit. This means hsCRP should be at least 1.5 times the upper limit of normal or 4.5 mg/L.
  • Must have a Disease Activity Score (DAS28-CRP) greater than 4.1 at the Screening Visit. This score measures the activity of RA.
  • Must have a high level of IgG+ Anti-Citrullinated Protein Antibody (ACPA) at the Screening Visit, which should be at least 3 times the upper limit of normal or 30 units/mL. This is a specific antibody found in RA patients.
  • Must have had an inadequate response to 2 or 3, but not more than 3, classes of biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). These are medications used to treat RA.
  • Both male and female participants are eligible.
  • Participants should not be from a vulnerable population.

Who cannot join the trial?

8 criteria

  • Participants cannot have any other serious health conditions that might interfere with the study.
  • Participants should not have a history of allergic reactions to similar medications.
  • Participants cannot be pregnant or breastfeeding during the study.
  • Participants should not be using other medications that might interfere with the study drug.
  • Participants cannot have a history of drug or alcohol abuse.
  • Participants should not have participated in another clinical trial recently.
  • Participants cannot have any infections that are not well controlled.
  • Participants should not have any mental health conditions that might affect their ability to participate in the study.
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Investigated drugs

IMVT-1402 is a medication being studied for its potential to help people with rheumatoid arthritis, a condition that causes pain and swelling in the joints. This medication is being tested to see if it can improve symptoms in people who have a type of rheumatoid arthritis that is hard to treat. The goal is to see if it can help reduce joint pain and swelling, making it easier for people to move and perform daily activities. The study is looking at how well this medication works, how safe it is, and how well people can tolerate it. By participating in this study, researchers hope to find out if IMVT-1402 can be a new option for people with this challenging condition.

What is already known about the treatment

IMVT-1402 – IMVT-1402 is administered as an injection and is currently being studied in clinical trials for its potential use in treating rheumatoid arthritis, specifically in patients who have a form of the disease that is difficult to manage and test positive for ACPA. This medication is not yet widely available in medical practice, as it is still under investigation to determine its effectiveness and safety. The main goal of using IMVT-1402 is to help reduce the symptoms of rheumatoid arthritis, such as joint pain and swelling, by targeting specific pathways in the immune system that contribute to inflammation. It belongs to a class of drugs known as immunomodulators, which work by adjusting the immune system's activity to help control the disease.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid Arthritis is a chronic inflammatory disorder that primarily affects joints. It occurs when the immune system mistakenly attacks the body's tissues, leading to inflammation. Over time, this inflammation can cause joint damage and deformities. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the wrists, knees, and ankles. As it progresses, it can cause pain, swelling, and stiffness, particularly in the morning or after periods of inactivity. Rheumatoid Arthritis can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515973-82-00Protocol codeIMVT-1402-2601Estimated enrolment185 patientsSponsorImmunovant Sciences GmbH

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