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
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