ClinicalTrials.gg
RecruitingNCT07032662Updated Sep 30, 2026

Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Phase 2 interventional study of Imeroprubart and Placebo in Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Immunovant Sciences GmbH. Recruiting at 142 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Immunovant Sciences GmbH · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Updated Sep 30, 2026Eligibility revisedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

  • Chronic Inflammatory Demyelinating Polyneuropathy
  • IMVT-1402
  • Monoclonal antibody
  • Human immunoglobulin G1 (IgG1)
  • CIDP
  • Imeroprubart
03

In context

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.

This study's planned enrollment of 162 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Lead sponsor

Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 30, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (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.

Exclusion criteria

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    Imeroprubart

    Drug: Imeroprubart

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)

  • DrugPlacebo

    Matching placebo SC QW for 24 weeks (Period 1)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)

    Time frame: Baseline and Up to Week 24

  2. Change from baseline to Week 24 in Mean Grip Strength in the dominant hand

    Time frame: Baseline and Up to Week 24

  3. Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)

    Time frame: Baseline and Up to Week 24

  4. Change from baseline to Week 24 in aINCAT score

    Time frame: Baseline and Up to Week 24

07

Study locations

117 of 142 sites recruiting
  • Site Number - 1612
    Tucson, Arizona 85718, United States
    Recruiting
  • Site Number - 1618
    Carlsbad, California 92011, United States
    Recruiting
  • Site Number - 1637
    Mission Hills, California 91345, United States
    Recruiting
  • Site Number - 1619
    Orange, California 92868, United States
    Recruiting
  • Site Number - 1607
    Rancho Mirage, California 92270, United States
    Recruiting
  • Site Number -1608
    San Francisco, California 94109, United States
    Recruiting
  • Site Number - 1626
    Parker, Colorado 80138, United States
    Recruiting
  • Site Number - 1621
    New Haven, Connecticut 06511, United States
    Recruiting
  • Site Number - 1630
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Site Number - 1601
    Washington D.C., District of Columbia 20037, United States
    Recruiting
  • Site Number - 1603
    Maitland, Florida 32751, United States
    Recruiting
  • Site Number - 1606
    Miami, Florida 33136, United States
    Recruiting
  • Site Number - 1617
    Ormond Beach, Florida 32174, United States
    Recruiting
  • Site Number - 1620
    Port Charlotte, Florida 33952, United States
    Recruiting
  • Site Number - 1633
    Rockledge, Florida 32955, United States
    Recruiting
  • Site Number - 1632
    Chicago, Illinois 60637-1443, United States
    Recruiting
  • Site Number - 1602
    Kansas City, Kansas 66205, United States
    Recruiting
  • Site Number - 1611
    Nicholasville, Kentucky 40356, United States
    Recruiting
  • Site Number - 1623
    Boston, Massachusetts 02114, United States
    Recruiting
  • Site Number - 1625
    Worcester, Massachusetts 01655, United States
    Recruiting
  • Site Number - 1629
    Detroit, Michigan 48201, United States
    Recruiting
  • Site Number - 1634
    Las Vegas, Nevada 89106, United States
    Recruiting
  • Site Number - 1605
    New York, New York 10032, United States
    Recruiting
  • Site Number - 1627
    New York, New York 10065, United States
    Recruiting
  • Site Number - 1635
    Chapel Hill, North Carolina 27514, United States
    Not yet recruiting
  • Site Number - 1610
    Charlotte, North Carolina 28204, United States
    Recruiting
  • Site Number - 1624
    Canton, Ohio 44718, United States
    Not yet recruiting
  • Site Number - 1631
    Yukon, Oklahoma 73099, United States
    Recruiting
  • Site Number - 1614
    Portland, Oregon 97239, United States
    Recruiting
  • Site Number - 1616
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
  • Site Number - 1622
    Houston, Texas 77030, United States
    Recruiting
  • Site Number - 1628
    San Antonio, Texas 78229, United States
    Recruiting
  • Site Number - 1613
    Milwaukee, Wisconsin 53226, United States
    Recruiting
  • Site Number - 5005
    Rosario, Santa Fe Province, Argentina
    Recruiting
  • Site Number - 5002
    Buenos Aires, Argentina
    Not yet recruiting
  • Site Number - 5006
    Buenos Aires, Argentina
    Recruiting
  • Site Number - 5001
    Córdoba, Argentina
    Recruiting
  • Site Number - 5003
    Córdoba, Argentina
    Recruiting
  • Site Number - 5000
    Rosario, Argentina
    Recruiting
  • Site Number - 5100
    Macquarie Park, Australia
    Recruiting
  • Site Number - 5103
    Parkville, Australia
    Recruiting
  • Site Number - 5102
    Woolloongabba, Australia
    Recruiting
  • Site Number - 5200
    Vienna, Austria
    Recruiting
  • Site Number - 5300
    Leuven, Belgium
    Recruiting
  • Site Number - 5400
    Banja Luka, Bosnia and Herzegovina
    Recruiting
  • Site Number - 5402
    Bihać, Bosnia and Herzegovina
    Not yet recruiting
  • Site Number - 5401
    Mostar, Bosnia and Herzegovina
    Recruiting
  • Site Number - 5403
    Sarajevo, Bosnia and Herzegovina
    Recruiting
  • Site Number - 5507
    Belo Horizonte, Brazil
    Recruiting
  • Site Number - 5506
    Brasília, Brazil
    Recruiting
  • Site Number - 5503
    Campinas, Brazil
    Not yet recruiting
  • Site Number - 5500
    Curitiba, Brazil
    Recruiting
  • Site Number - 5502
    Joinville, Brazil
    Recruiting
  • Site Number - 5501
    Porto Alegre, Brazil
    Recruiting
  • Site Number - 5504
    Porto Alegre, Brazil
    Recruiting
  • Site Number - 5505
    Vila Clementino, Brazil
    Recruiting
  • Site Number - 5601
    Pleven, Bulgaria
    Recruiting
  • Site Number - 5600
    Sofia, Bulgaria
    Recruiting
  • Site Number - 5602
    Sofia, Bulgaria
    Recruiting
  • Site Number - 5603
    Sofia, Bulgaria
    Recruiting
  • Site Number - 5604
    Sofia, Bulgaria
    Recruiting
  • Site Number - 5800
    Bogotá, Colombia
    Not yet recruiting
  • Site Number - 3600
    Copenhagen, Denmark
    Recruiting
  • Site Number - 3601
    Odense, Denmark
    Recruiting
  • Site Number - 7251
    Tallinn, Estonia
    Recruiting
  • Site Number - 3800
    Turku, Finland
    Recruiting
  • Site Number - 6505
    Berlin, Germany
    Not yet recruiting
  • Site Number - 6501
    Bochum, Germany
    Recruiting
  • Site Number - 6504
    Essen, Germany
    Not yet recruiting
  • Site Number - 6500
    Tübingen, Germany
    Not yet recruiting
  • Site Number - 6503
    Ulm, Germany
    Recruiting
  • Site Number - 6502
    Würzburg, Germany
    Recruiting
  • Site Number - 3901
    Alexandroupoli, Greece
    Recruiting
  • Site Number - 3902
    Athens, Greece
    Recruiting
  • Site Number - 3905
    Chaïdári, Greece
    Recruiting
  • Site Number - 3906
    Heraklion, Greece
    Not yet recruiting
  • Site Number - 3903
    Ioannina, Greece
    Not yet recruiting
  • Site Number - 3904
    Larissa, Greece
    Recruiting
  • Site Number - 3900
    Pátrai, Greece
    Recruiting
  • Site Number - 7551
    Budapest, Hungary
    Not yet recruiting
  • Site Number - 7550
    Kistarcsa, Hungary
    Recruiting
  • Site Number - 7552
    Pécs, Hungary
    Recruiting
  • Site Number - 4100
    Waterford, Ireland
    Not yet recruiting
  • Site Number - 6004
    Bergamo, Italy
    Recruiting
  • Site Number - 6007
    Bologna, Italy
    Recruiting
  • Site Number - 6000
    Brescia, Italy
    Recruiting
  • Site Number - 6009
    Milan, Italy
    Recruiting
  • Site Number - 6001
    Milan, Italy
    Recruiting
  • Site Number -6005
    Milan, Italy
    Recruiting
  • Site Number - 6011
    Pavia, Italy
    Recruiting
  • Site Number - 6010
    Pisa, Italy
    Not yet recruiting
  • Site Number - 6002
    Roma, Italy
    Recruiting
  • Site Number - 6006
    Roma, Italy
    Recruiting
  • Site Number - 6003
    Siena, Italy
    Recruiting
  • Site Number - 2603
    Colonia del Valle, Mexico
    Not yet recruiting
  • Site Number - 2600
    Culiacán, Mexico
    Recruiting
  • Site Number - 2602
    Tlalpan, Mexico
    Not yet recruiting
  • Site Number - 2601
    Veracruz, Mexico
    Recruiting
  • Site Number - 2200
    Utrecht, Netherlands
    Recruiting
  • Site Number - 2300
    Oslo, Norway
    Recruiting

Showing the first 100 of 142 sites across 30 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2025 (actual). Primary completion is estimated for Aug 2028, 41 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2025
First posted
Jun 24, 2025
StartActual
Mar 18, 2025
Primary completionEst.
Aug 2028
CompletionEst.
May 2030
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
2 inclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedHave 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.
  • EditedAre 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.
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Eligibility 2 inclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedHave 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.
    • EditedAre 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.

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07032662
Lead sponsor
Immunovant Sciences GmbH
Responsible party
Sponsor
First posted
Jun 24, 2025
Start date
Mar 18, 2025
Primary completion
Aug 2028 (estimated)
Completion
May 2030 (estimated)
Last update
Sep 30, 2026

Study contacts

Study Contact
Contact
clinicaltrials@immunovant.com
18007970414

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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