120 Participants Needed

IMVT-1402 for Rheumatoid Arthritis

Recruiting at 70 trial locations
CS
Overseen ByCentral Study Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Immunovant Sciences GmbH
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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

Are you still having joint pain or swelling even on your current medication?
Has your rheumatoid arthrisit lasted at least six months?
In the past month, have you had several painful and swollen joints most days, even while on medication?

Exclusion Criteria

Have you had an IV or injectable drug like Humira, Enbrel, Rituxan, Orencia, or Xeljanz within the last few months?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

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

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

12 weeks

Long-Term Extension

Eligible participants who complete Period 2 have the option to receive IMVT-1402 for an additional 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IMVT-1402
Trial Overview The study tests IMVT-1402 against a placebo in people with difficult rheumatoid arthritis. It's double-blind (neither doctors nor patients know who gets what), randomized (assigned by chance), and aims to see if IMVT-1402 can improve symptoms better than an inactive substance.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: IMVT-1402 Dose 2Experimental Treatment1 Intervention
Group II: IMVT-1402 Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immunovant Sciences GmbH

Lead Sponsor

Trials
12
Recruited
1,400+

Published Research Related to This Trial

CD147 is significantly upregulated in memory T cells from rheumatoid arthritis (RA) patients, indicating its potential role in the abnormal activation of these cells in the disease.
The anti-CD147 monoclonal antibody 5A12 effectively inhibits the activation and proliferation of memory T cells, suggesting it could be a promising therapeutic target for treating RA and other T-cell-mediated autoimmune diseases.
A critical epitope in CD147 facilitates memory CD4+ T-cell hyper-activation in rheumatoid arthritis.Guo, N., Ye, S., Zhang, K., et al.[2021]
CD147 is linked to increased levels of VEGF and HIF-1α, which promote angiogenesis in rheumatoid arthritis (RA), suggesting that targeting CD147 could help reduce inflammation and blood vessel growth in this disease.
In experiments with RA fibroblast-like synoviocytes and a mouse model, inhibiting CD147 led to a greater reduction in VEGF and HIF-1α production compared to the standard treatment infliximab, indicating that CD147 suppression may be a more effective therapeutic strategy.
CD147 induces angiogenesis through a vascular endothelial growth factor and hypoxia-inducible transcription factor 1α-mediated pathway in rheumatoid arthritis.Wang, CH., Yao, H., Chen, LN., et al.[2017]
In a study involving 87 patients with rheumatoid arthritis (RA) and 29 healthy controls, researchers found that the percentage of circulating angiogenic T cells (Tang cells) was significantly higher in RA patients and correlated with disease activity and levels of proangiogenic cytokines.
The study identified that CD147 is crucial for the activation of Tang cells, influencing their production of VEGF through the Akt signaling pathway, which may contribute to the angiogenesis observed in RA.
CD147 participates in the activation function of circulating angiogenic T cells in patients with rheumatoid arthritis.Zhao, P., Miao, J., Zhang, K., et al.[2020]

Citations

NCT06754462 | A Study to Evaluate the Efficacy, Safety, ...The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response ...
Document... IMVT-1402 in GD expected by year end. •IND cleared for IMVT-1402 in rheumatoid arthritis (RA), with potential best-in-class profile in ...
A Study to Evaluate the Efficacy, Safety, and Tolerability of ...This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult ...
Press ReleasesIMVT-1402 is being developed in six indications, including ongoing potentially registrational trials in GD, MG, CIDP, D2T RA and SjD, and a ...
A Study to Evaluate the Efficacy, Safety, and Tolerability of ...The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response at ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security