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Clinical Trials/NCT07032662
NCT07032662RecruitingPhase 2

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Immunovant Sciences GmbH167 sites in 18 countries162 target enrollmentStarted: March 18, 2025Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
162
Locations
167
Primary Endpoint
Proportion of participants remaining Relapse-free by Week 24
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Imeroprubart in adult participants with active CIDP.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

Sponsor, care provider and outcome assessor will also be blinded.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Imeroprubart

Experimental

Intervention: Imeroprubart (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Proportion of participants remaining Relapse-free by Week 24

Time Frame: 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 Outcomes

  • Change from baseline to Week 24 in aINCAT score(Baseline and Up to Week 24)
  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (167)

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