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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07032662
Registration number
NCT07032662
Ethics application status
Date submitted
11/06/2025
Date registered
24/06/2025
Date last updated
24/06/2025
Titles & IDs
Public title
IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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Scientific title
A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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Secondary ID [1]
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IMVT-1402-2401
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Inflammatory Demyelinating Polyneuropathy
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Condition category
Condition code
Neurological
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Other neurological disorders
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Inflammatory and Immune System
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IMVT-1402
Treatment: Drugs - Placebo
Experimental: IMVT-1402 -
Placebo comparator: Placebo -
Treatment: Drugs: IMVT-1402
Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
Treatment: Drugs: Placebo
Matching placebo SC QW for 24 weeks (Period 1)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants remaining Relapse-free by Week 24
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [1]
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Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)
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Assessment method [1]
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Timepoint [1]
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Baseline and Up to Week 24
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Secondary outcome [2]
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Change from baseline to Week 24 in Mean Grip Strength in the dominant hand
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Assessment method [2]
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Timepoint [2]
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Baseline and Up to Week 24
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Secondary outcome [3]
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Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Change from baseline to Week 24 in aINCAT score
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Assessment method [4]
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Timepoint [4]
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Baseline and Up to Week 24
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2030
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Actual
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Sample size
Target
162
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site Number - 5102 - Brisbane
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Recruitment hospital [2]
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Site Number - 5100 - Macquarie Park
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Recruitment hospital [3]
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Site Number - 5103 - Parkville
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- Brisbane
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Recruitment postcode(s) [2]
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- Macquarie Park
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Recruitment postcode(s) [3]
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- Parkville
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Funding & Sponsors
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Name
Immunovant Sciences GmbH
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.
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Trial website
https://clinicaltrials.gov/study/NCT07032662
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Phone
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18007970414
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07032662
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