IMVT-1402 for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Recruiting at 133 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Immunovant Sciences GmbH

Must be taking: Corticosteroids, Immunoglobulin therapy

Disqualifiers: IgM paraproteinemia, Diabetes, Myelopathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment called IMVT-1402 for individuals with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), a condition that causes nerve damage and muscle weakness. Researchers aim to determine if this treatment can manage CIDP symptoms more effectively than a placebo (a substance with no active drug). Individuals with CIDP who have been on stable doses of corticosteroids or immunoglobulin therapy for at least three months might be suitable candidates for this study. Joining this trial could contribute to discovering better ways to treat CIDP. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you continue taking your current medications, such as corticosteroids or immunoglobulin therapy, as long as they have been stable for at least 3 months before the screening.

Is there any evidence suggesting that IMVT-1402 is likely to be safe for humans?

Research has shown that IMVT-1402 is under study to determine its safety and efficacy for individuals with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Although specific safety information about IMVT-1402 is limited, its progression to a Phase 2 study indicates that some safety data has been collected, likely from earlier research. Treatments reaching this stage typically demonstrate some safety in initial tests, often involving healthy volunteers.

Researchers closely monitor clinical trials for any side effects. If IMVT-1402 had exhibited serious safety issues earlier, it likely would not have advanced to this stage. Nonetheless, participants in this trial will be closely observed to ensure the treatment remains safe and any side effects are manageable.

Consult a healthcare provider to determine if joining a trial is the right decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), which often include corticosteroids, IVIG, or plasma exchange, IMVT-1402 is unique because it targets the disease with a novel mechanism of action. It works by modulating the immune system in a way that potentially reduces inflammation more precisely and with fewer side effects. Researchers are excited about IMVT-1402 because it offers a promising alternative that could lead to better outcomes for patients who haven't responded well to existing therapies.

What evidence suggests that IMVT-1402 might be an effective treatment for CIDP?

Studies have shown that IMVT-1402, which participants in this trial may receive, holds promising potential for treating conditions like chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). For example, a similar drug, batoclimab, significantly improved symptoms in patients with myasthenia gravis, another autoimmune disease. IMVT-1402 aims to reduce harmful immune responses in the body. Early research suggests it may help improve muscle strength and reduce disability in patients with CIDP. While more data is needed, these findings indicate that IMVT-1402 could be effective for CIDP by adjusting the immune system. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who have been on stable doses of corticosteroids or immunoglobulin therapy for at least 3 months can join. Those with diabetes not well-controlled, other types of neuropathies, IgM paraproteinemia, or central demyelination cannot participate.

Inclusion Criteria

Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP

I have been diagnosed with CIDP or a specific type of it according to the 2021 guidelines.

I have been on stable doses of corticosteroids or immunoglobulin therapy for CIDP for at least 3 months.

Exclusion Criteria

I have diabetes and meet specific criteria for a CIDP diagnosis and managing my diabetes.

I have a type of nerve damage not caused by CIDP, such as from diabetes or toxins.

Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IMVT-1402 or placebo in a double-blind manner

24 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 trial is testing IMVT-1402's effectiveness and safety against a placebo in adults with CIDP. It's a Phase 2b study where participants are randomly assigned to receive either the experimental drug or an inactive substance.

How Is the Trial Designed?

Group I: IMVT-1402 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Immunovant Sciences GmbH

Lead Sponsor

Trials

12

Recruited

1,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07032662

IMVT-1402 in Adult Participants With Chronic Inflammatory ... This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active ...

2. immunovant.com immunovant.com/investors/news-events/press-releases/detail/71/immunovant-announces-positive-results-for-batoclimab

Immunovant Announces Positive Results for Batoclimab ... Pivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in ...

3. rarediseaseadvisor.com rarediseaseadvisor.com/news/investigate-imvt-1402-patients-cidp/

IMVT-1402 Evaluated for Use in Patients With CIDP Additional outcomes include changes in Inflammatory Rasch-Built Overall Disability Scale score, dominant hand mean grip strength, Medical ...

4. immunovant.com immunovant.com/investors/news-events/press-releases/detail/77/immunovant-provides-corporate-updates-and-reports-financial

Press Releases The Immunovant study in uncontrolled GD patients treated for 24 weeks showed first-ever potentially disease-modifying therapy with six-month off ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07032662/imvt-1402-in-adult-participants-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp

IMVT-1402 in Adult Participants With Chronic Inflammatory ... This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07032662?term=SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DAustralia)&rank=7

IMVT-1402 in Adult Participants With Chronic Inflammatory ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. trial.medpath.com trial.medpath.com/clinical-trial/ca2868c2701c3a5c/nct07032662-imvt-1402-treatment-chronic-inflammatory-demyelinating-polyneuropathy

IMVT-1402 in Adult Participants With Chronic Inflammatory ... This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.