120 Participants Needed

IMVT-1402 for Rheumatoid Arthritis

Recruiting at 44 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 Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).

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.

What is the safety profile of Iguratimod for treating rheumatoid arthritis and other conditions?

Iguratimod has been shown to have few adverse events and a safety profile similar to other treatments like methotrexate and sulfasalazine for rheumatoid arthritis. In studies for spondyloarthritis, some patients experienced mild gastrointestinal discomfort and elevated liver enzymes, but overall, it was considered safe and well-tolerated.12345

What makes the drug IMVT-1402 unique for treating rheumatoid arthritis?

IMVT-1402 may be unique in treating rheumatoid arthritis by targeting CD147, a molecule involved in T cell activation, which can limit the proliferation of Th17 cells and reduce inflammation and joint damage.678910

What data supports the effectiveness of the drug IMVT-1402 for treating rheumatoid arthritis?

The effectiveness of treatments for rheumatoid arthritis has improved with strategies like 'treat-to-target' (T2T), which focuses on achieving remission (no active disease). Advances in therapies, including monoclonal antibodies that target specific inflammatory processes, have shown promise in managing rheumatoid arthritis, suggesting potential for new treatments like IMVT-1402.1112131415

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

The treat-to-target (T2T) initiative aims to establish benchmarks for effectively managing rheumatoid arthritis (RA) treatment, focusing on achieving remission as a primary goal.
Inpatient rheumatology has successfully implemented quality management projects, such as the outcome benchmarking project (OBRA), which align with T2T guidelines, leading to improved outcomes for RA patients through collaboration among competing clinics.
[Treat-to-target (T2T) from the perspective of inpatient rheumatology].Lakomek, HJ., Krause, A.[2021]
The 'treat-to-target' (T2T) approach in rheumatoid arthritis, which focuses on objective measures of disease activity, has been shown to improve clinical outcomes and make remission a realistic goal.
Recent advancements include new definitions of remission and the use of imaging to guide treatment decisions, highlighting the evolving strategies in managing rheumatoid arthritis effectively.
The "Treat to Target" Approach to Rheumatoid Arthritis.Salomon-Escoto, K., Kay, J.[2020]
Despite advances in rheumatoid arthritis (RA) treatment, including new therapies and better diagnostic criteria, most patients still do not achieve remission, highlighting the need for ongoing development of novel therapies.
The review discusses new therapeutic antibodies targeting various cytokines and inflammatory mediators, which are in different stages of clinical development, aiming to enhance treatment options for RA.
Emerging therapies in rheumatoid arthritis: focus on monoclonal antibodies.Senolt, L.[2020]

Citations

[Treat-to-target (T2T) from the perspective of inpatient rheumatology]. [2021]
The "Treat to Target" Approach to Rheumatoid Arthritis. [2020]
Emerging therapies in rheumatoid arthritis: focus on monoclonal antibodies. [2020]
[New therapeutic methods against rheumatoid arthritisp6. Antibodies against TNFalpha significant for the progress]. [2012]
Trends in the activity of rheumatoid arthritis as the consequence of treat-to-target strategy: eight-year data from 2009 to 2016. [2019]
Efficacy and safety of iguratimod for the treatment of rheumatoid arthritis. [2021]
Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0. [2022]
Randomised, Double-Blind, Placebo-Controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis. [2021]
Methotrexate as the initial second-line disease modifying agent in the treatment of rheumatoid arthritis patients. [2017]
Safety of extended treatment with anakinra in patients with rheumatoid arthritis. [2018]
CD147 Expressed on Memory CD4+ T Cells Limits Th17 Responses in Patients With Rheumatoid Arthritis. [2021]
A critical epitope in CD147 facilitates memory CD4+ T-cell hyper-activation in rheumatoid arthritis. [2021]
CD147 participates in the activation function of circulating angiogenic T cells in patients with rheumatoid arthritis. [2020]
[Neutrophil enhanced matrix metalloproteinase production and invasion of synoviocytes of RA via CD147]. [2017]
15.United Statespubmed.ncbi.nlm.nih.gov
CD147 induces angiogenesis through a vascular endothelial growth factor and hypoxia-inducible transcription factor 1α-mediated pathway in rheumatoid arthritis. [2017]
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