Chronic Inflammatory Demyelinating PolyneuropathyPhase 2NCT07032662
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Phase 2 study testing Imeroprubart in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Immunovant Sciences GmbH at 142 sites in 30 countries.
Trial summary
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Imeroprubart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 142 sitesin 30 countries
- Study dates
- 18 Mar 2025to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have met clinical diagnostic criteria for typical CIDP (including incomplete 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) ± corticosteroid therapy (either low dose oral corticosteroids or pulse 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
142 sites in 30 countries. Contact the study team or a site near you to ask about taking part.
142 sites in 30 countries
United States33 sites, 33 recruiting
- Recruiting
Site Number - 1623
Boston, Massachusetts, 02114
- Not yet recruiting
Site Number - 1624
Canton, Ohio, 44718
- Recruiting
Site Number - 1618
Carlsbad, California, 92011
- Not yet recruiting
Site Number - 1635
Chapel Hill, North Carolina, 27514
- Recruiting
Site Number - 1610
Charlotte, North Carolina, 28204
- Recruiting
Site Number - 1632
Chicago, Illinois, 60637-1443
- Recruiting
Site Number - 1629
Detroit, Michigan, 48201
- Recruiting
Site Number - 1622
Houston, Texas, 77030
- Recruiting
Site Number - 1602
Kansas City, Kansas, 66205
- Recruiting
Site Number - 1634
Las Vegas, Nevada, 89106
- Recruiting
Site Number - 1603
Maitland, Florida, 32751
- Recruiting
Site Number - 1606
Miami, Florida, 33136
- Recruiting
Site Number - 1613
Milwaukee, Wisconsin, 53226
- Recruiting
Site Number - 1637
Mission Hills, California, 91345
- Recruiting
Site Number - 1621
New Haven, Connecticut, 06511
- Recruiting
Site Number - 1605
New York, New York, 10032
- Recruiting
Site Number - 1627
New York, New York, 10065
- Recruiting
Site Number - 1611
Nicholasville, Kentucky, 40356
- Recruiting
Site Number - 1619
Orange, California, 92868
- Recruiting
Site Number - 1617
Ormond Beach, Florida, 32174
- Recruiting
Site Number - 1626
Parker, Colorado, 80138
- Recruiting
Site Number - 1616
Philadelphia, Pennsylvania, 19107
- Recruiting
Site Number - 1620
Port Charlotte, Florida, 33952
- Recruiting
Site Number - 1614
Portland, Oregon, 97239
- Recruiting
Site Number - 1607
Rancho Mirage, California, 92270
- Recruiting
Site Number - 1633
Rockledge, Florida, 32955
- Recruiting
Site Number - 1628
San Antonio, Texas, 78229
- Recruiting
Site Number -1608
San Francisco, California, 94109
- Recruiting
Site Number - 1612
Tucson, Arizona, 85718
- Recruiting
Site Number - 1630
Washington D.C., District of Columbia, 20010
- Recruiting
Site Number - 1601
Washington D.C., District of Columbia, 20037
- Recruiting
Site Number - 1625
Worcester, Massachusetts, 01655
- Recruiting
Site Number - 1631
Yukon, Oklahoma, 73099
Italy11 sites, 11 recruiting
- Recruiting
Site Number - 6004
Bergamo
- Recruiting
Site Number - 6007
Bologna
- Recruiting
Site Number - 6000
Brescia
- Recruiting
Site Number - 6009
Milan
- Recruiting
Site Number - 6001
Milan
- Recruiting
Site Number -6005
Milan
- Recruiting
Site Number - 6011
Pavia
- Not yet recruiting
Site Number - 6010
Pisa
- Recruiting
Site Number - 6002
Roma
- Recruiting
Site Number - 6006
Roma
- Recruiting
Site Number - 6003
Siena
Poland10 sites, 10 recruiting
- Recruiting
Site Number - 3007
Bydgoszcz
- Not yet recruiting
Site Number - 3008
Gdansk
- Recruiting
Site Number - 3004
Katowice
- Recruiting
Site Number - 3000
Krakow
- Recruiting
Site Number - 3003
Krakow
- Recruiting
Site Number - 3009
Lublin, Lublin Voivodeship
- Recruiting
Site Number - 3001
Lublin
- Recruiting
Site Number - 3005
Lublin
- Recruiting
Site Number - 3002
Poznan
- Not yet recruiting
Site Number - 3006
Warsaw
Brazil8 sites, 8 recruiting
- Recruiting
Site Number - 5507
Belo Horizonte
- Recruiting
Site Number - 5506
Brasília
- Not yet recruiting
Site Number - 5503
Campinas
- Recruiting
Site Number - 5500
Curitiba
- Recruiting
Site Number - 5502
Joinville
- Recruiting
Site Number - 5501
Porto Alegre
- Recruiting
Site Number - 5504
Porto Alegre
- Recruiting
Site Number - 5505
Vila Clementino
Greece7 sites, 7 recruiting
- Recruiting
Site Number - 3901
Alexandroupoli
- Recruiting
Site Number - 3902
Athens
- Recruiting
Site Number - 3905
Chaïdári
- Not yet recruiting
Site Number - 3906
Heraklion
- Not yet recruiting
Site Number - 3903
Ioannina
- Recruiting
Site Number - 3904
Larissa
- Recruiting
Site Number - 3900
Pátrai
Argentina6 sites, 6 recruiting
- Not yet recruiting
Site Number - 5002
Buenos Aires
- Recruiting
Site Number - 5006
Buenos Aires
- Recruiting
Site Number - 5001
Córdoba
- Recruiting
Site Number - 5003
Córdoba
- Recruiting
Site Number - 5005
Rosario, Santa Fe Province
- Recruiting
Site Number - 5000
Rosario
Germany6 sites, 6 recruiting
- Not yet recruiting
Site Number - 6505
Berlin
- Recruiting
Site Number - 6501
Bochum
- Not yet recruiting
Site Number - 6504
Essen
- Not yet recruiting
Site Number - 6500
Tübingen
- Recruiting
Site Number - 6503
Ulm
- Recruiting
Site Number - 6502
Würzburg
Spain6 sites, 6 recruiting
- Recruiting
Site Number - 7100
Barcelona
- Recruiting
Site Number - 7101
Barcelona
- Not yet recruiting
Site Number - 7104
Bilbao
- Recruiting
Site Number - 7103
Córdoba
- Recruiting
Site Number - 7102
Santiago de Compostela
- Recruiting
Site Number - 7105
Valencia
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Site Number - 4250
Bakırköy
- Not yet recruiting
Site Number - 4253
Başakşehir
- Recruiting
Site Number - 4255
Bursa
- Not yet recruiting
Site Number - 4251
Istanbul
- Recruiting
Site Number - 4254
Izmir
- Recruiting
Site Number - 4252
Samsun
Bulgaria5 sites, 5 recruiting
- Recruiting
Site Number - 5601
Pleven
- Recruiting
Site Number - 5600
Sofia
- Recruiting
Site Number - 5602
Sofia
- Recruiting
Site Number - 5603
Sofia
- Recruiting
Site Number - 5604
Sofia
Bosnia and Herzegovina4 sites, 4 recruiting
- Recruiting
Site Number - 5400
Banja Luka
- Not yet recruiting
Site Number - 5402
Bihać
- Recruiting
Site Number - 5401
Mostar
- Recruiting
Site Number - 5403
Sarajevo
Mexico4 sites, 4 recruiting
- Not yet recruiting
Site Number - 2603
Colonia del Valle
- Recruiting
Site Number - 2600
Culiacán
- Not yet recruiting
Site Number - 2602
Tlalpan
- Recruiting
Site Number - 2601
Veracruz
Serbia4 sites, 4 recruiting
- Recruiting
Site Number - 9000
Belgrade
- Recruiting
Site Number - 9003
Belgrade
- Recruiting
Site Number -9002
Kragujevac
- Recruiting
Site Number - 9001
Niš
United Kingdom4 sites, 4 recruiting
- Recruiting
Site Number - 7001
Bristol
- Not yet recruiting
Site Number - 7002
Glasgow
- Recruiting
Site Number - 7000
Salford
- Recruiting
Site Number - 7003
Southampton
Australia3 sites, 3 recruiting
- Recruiting
Site Number - 5100
Macquarie Park
- Recruiting
Site Number - 5103
Parkville
- Recruiting
Site Number - 5102
Woolloongabba
Hungary3 sites, 3 recruiting
- Not yet recruiting
Site Number - 7551
Budapest
- Recruiting
Site Number - 7550
Kistarcsa
- Recruiting
Site Number - 7552
Pécs
Peru3 sites, 3 recruiting
- Not yet recruiting
Site Number - 2401
Callao
- Recruiting
Site Number - 2400
Lima
- Recruiting
Site Number - 2403
Miraflores
Portugal3 sites, 3 recruiting
- Recruiting
Site Number -2902
Almada
- Recruiting
Site Number - 2901
Matosinhos Municipality
- Recruiting
Site Number - 2903
Vila Nova de Gaia
Slovakia3 sites, 3 recruiting
- Not yet recruiting
Site Number - 2800
Martin
- Recruiting
Site Number - 2802
Prešov
- Recruiting
Site Number - 2801
Rimavská Sobota
Denmark2 sites, 2 recruiting
- Recruiting
Site Number - 3600
Copenhagen
- Recruiting
Site Number - 3601
Odense
Romania2 sites, 2 recruiting
- Not yet recruiting
Site Number - 7503
Bucharest
- Recruiting
Site Number - 7500
Constanța
About this study
Official 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)
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
Read the 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.
- Being tested
- Imeroprubart, Placebo
- Keywords
- Chronic Inflammatory Demyelinating Polyneuropathy, IMVT-1402, Monoclonal antibody, Human immunoglobulin G1 (IgG1), CIDP, Imeroprubart
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImeroprubartDrug
Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
PlaceboDrug
Matching placebo SC QW for 24 weeks (Period 1)
| Study group | Role | What they receive |
|---|---|---|
| Imeroprubart | Experimental | Not described Receives: Drug: Imeroprubart |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants remaining Relapse-free by 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.
Measured: Baseline, Week 24
Secondary outcomes (4)
Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)
Measured: Baseline and Up to Week 24
Change from baseline to Week 24 in Mean Grip Strength in the dominant hand
Measured: Baseline and Up to Week 24
Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)
Measured: Baseline and Up to Week 24
Change from baseline to Week 24 in aINCAT score
Measured: Baseline and Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start18 Mar 2025
- Primary completionAug 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032662
- Sponsor's protocol ID
- IMVT-1402-2401
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07032662
- Acronym / sponsor ID
- IMVT-1402-2401
- Keywords
- Chronic Inflammatory Demyelinating Polyneuropathy, IMVT-1402, Monoclonal antibody, Human immunoglobulin G1 (IgG1), CIDP, Imeroprubart
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imeroprubart | Experimental | Drug: Imeroprubart |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have met clinical diagnostic criteria for typical CIDP (including incomplete 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) ± corticosteroid therapy (either low dose oral corticosteroids or pulse 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.
Key exclusion criteria (14 listed)
- 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:
- Have diabetes mellitus (DM) and meets any of the following criteria:
- Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImeroprubartDose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2) | Drug | Imeroprubart |
| PlaceboMatching placebo SC QW for 24 weeks (Period 1) | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)
Time frame: Baseline and Up to Week 24
Change from baseline to Week 24 in Mean Grip Strength in the dominant hand
Time frame: Baseline and Up to Week 24
Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)
Time frame: Baseline and Up to Week 24
Change from baseline to Week 24 in aINCAT score
Time frame: Baseline and Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
142 sites in 30 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imeroprubart in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Immunovant Sciences GmbH at 142 sites in 30 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 142 sites in United States, Italy, Poland, Brazil, Greece and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (18007970414, clinicaltrials@immunovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants remaining Relapse-free by Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.