IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Phase 2

Recruiting

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
• Interventions: Drug: IMVT-1402; Drug: Placebo

• Registration Number: NCT07032662
• Lead Sponsor: Immunovant Sciences GmbH

Brief Summary

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

Detailed Description

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 CIDP.

Study Timeline

• Study Start: 2025-03-18
• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2028-08
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment of CIDP.
• Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP.
• Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.

Additional inclusion criteria are defined in the protocol.

Exclusion Criteria

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

• Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP.

• Have polyneuropathy of causes other than CIDP including but not limited to:

  • Multifocal motor neuropathy
  • Hereditary demyelinating neuropathy
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)
  • Lumbosacral radiculoplexus neuropathy
  • Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies
  • Drug- or toxin-induced

• Have diabetes mellitus (DM) and meets any of the following criteria:

  • Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.
  • In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.
  • In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.

• Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMVT-1402	IMVT-1402	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants remaining Relapse-free by Week 24	Baseline, Week 24	Relapse is defined as a worsening (increase) of ≥ 1 point on the adjusted inflammatory neuropathy cause and treatment (aINCAT) score at any time point relative to Period 1 Baseline.

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)	Baseline and Up to Week 24
Change from baseline to Week 24 in Mean Grip Strength in the dominant hand	Baseline and Up to Week 24
Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)	Baseline and Up to Week 24
Change from baseline to Week 24 in aINCAT score	Baseline and Up to Week 24

Trial Locations

Locations (134)

Site Number - 1612; 🇺🇸 Tucson, Arizona, United States

Site Number - 1618; 🇺🇸 Carlsbad, California, United States

Site Number - 1619; 🇺🇸 Orange, California, United States

Site Number - 1607; 🇺🇸 Rancho Mirage, California, United States

Site Number -1608; 🇺🇸 San Francisco, California, United States

Site Number - 1626; 🇺🇸 Castle Rock, Colorado, United States

Site Number - 1621; 🇺🇸 New Haven, Connecticut, United States

Site Number - 1630; 🇺🇸 Washington, District of Columbia, United States

Site Number - 1601; 🇺🇸 Washington, District of Columbia, United States

Site Number - 1603; 🇺🇸 Maitland, Florida, United States

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