IMVT-1402 for Rheumatoid Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called IMVT-1402 for individuals with rheumatoid arthritis (RA), a condition causing painful joint swelling. The trial aims to evaluate the treatment's effectiveness and safety for those with difficult-to-manage RA. Participants will receive one of two doses of IMVT-1402 or a placebo, which contains no active medicine. The trial seeks participants who have struggled with RA, particularly those with swollen and tender joints, and who have not found success with at least two other RA treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop your current medications. However, it mentions that certain treatments, like non-immunosuppressive Fc-based proteins and anti-FcRn treatments, should not have been used recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that IMVT-1402 is likely to be safe for humans?
Research shows that IMVT-1402 is being tested for several conditions, including rheumatoid arthritis, indicating growing interest in its potential benefits and safety. Although specific side effects for rheumatoid arthritis are not yet available, its presence in a clinical trial suggests some safety and effectiveness in earlier studies.
IMVT-1402 is also under investigation for other diseases, implying general safety. This often means any side effects are mild or manageable. However, since each condition and individual may react differently, it is important to view this information as part of a broader context. Consulting healthcare professionals about potential risks and benefits is crucial before deciding to join a trial.12345Why do researchers think this study treatment might be promising for rheumatoid arthritis?
Researchers are excited about IMVT-1402 for rheumatoid arthritis because it offers a potentially new way to manage the condition. Most current treatments, like methotrexate or biologics such as TNF inhibitors, focus on suppressing the immune system broadly. IMVT-1402, however, may target specific pathways in the immune system more precisely, which could reduce inflammation with fewer side effects. Additionally, the different dosing options being explored might provide flexibility in treatment, making it easier to tailor therapy to individual patient needs.
What evidence suggests that IMVT-1402 might be an effective treatment for rheumatoid arthritis?
Research has shown that IMVT-1402 could be a promising treatment for rheumatoid arthritis (RA). Previous studies suggest it might be effective for individuals with RA, particularly those who haven't responded to other treatments. In this trial, participants will receive either IMVT-1402 at one of two doses or a placebo to determine if it can improve RA symptoms by 20%, based on a standard measure called ACR20. Researchers are also investigating the treatment for other conditions, suggesting it might offer wide-ranging benefits. It's important to note that IMVT-1402 remains under study, so further information is needed to confirm its effectiveness.12345
Are You a Good Fit for This Trial?
This trial is for adults with active, hard-to-treat rheumatoid arthritis who have not responded well to at least two types of advanced RA medications. Participants must meet specific criteria including a definite RA diagnosis, certain levels of joint tenderness and swelling, elevated C-reactive protein, and positive ACPA.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-Label Treatment
All eligible participants receive open-label treatment with IMVT-1402 at a dose of 600 mg subcutaneous once weekly for 16 weeks
Randomized Withdrawal
Participants who meet the ACR20 response criteria are randomized to receive blinded treatment with either IMVT-1402 600 mg, IMVT-1402 300 mg, or placebo subcutaneous once weekly for 12 weeks
Long-Term Extension
Eligible participants who complete Period 2 have the option to receive IMVT-1402 for an additional 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IMVT-1402
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunovant Sciences GmbH
Lead Sponsor