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Can a new antibody calm the immune attack in CIDP?

NCT ID NCT05581199

Disease control Sponsor: Immunovant Sciences GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial is testing whether an experimental drug called batoclimab can help adults with active chronic inflammatory demyelinating polyneuropathy (CIDP), a condition where the immune system damages nerves, causing weakness and disability. Participants receive either batoclimab or a placebo for 12 weeks, followed by a withdrawal period to see if the drug prevents relapses. The study aims to see if batoclimab can reduce disability and improve quality of life for people with CIDP.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
batoclimab (an experimental antibody that blocks a protein to lower harmful immune activity)
What this could lead to
If successful, batoclimab could offer a new treatment option for CIDP, potentially reducing relapses and improving daily function for people with this nerve disorder.
What could go wrong
This is a phase 2b trial with a relatively small number of participants, so results may not be definitive. Batoclimab may not prove more effective than placebo, and it could carry risks such as infections or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

94 people

The number who actually took part.

Started

Dec 2022

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: All Cohorts: 1. Are \>= 18 years at the Screening Visit. 2. Have met clinical diagnostic criteria for typical CIDP, or one of the following CIDP variants: multifocal CIDP, focal CIDP, or motor CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP. Clinical criteria for typical CIDP and variants are as follows (either criterion must be met): 1. Typical CIDP: All the following: * Progressive or relapsing, symmetric, proximal, and distal muscle weakness of upper and lower limbs, and sensory involvement of at least two limbs (at any point in the disease course) * Developing over at least 8 weeks * Absent or reduced tendon reflexes in all limbs 2. CIDP variants: One of the following, but otherwise as in typical CIDP (tendon reflexes may be normal in unaffected limbs): * Multifocal CIDP: documented sensory loss and muscle weakness in a multifocal pattern, usually asymmetric, upper limb predominant * Focal CIDP: sensory loss and muscle weakness in only one limb * Motor CIDP: motor symptoms and signs without sensory involvement Cohorts A and B: 3. Have electrodiagnostic test results supporting the diagnosis of CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP; for Cohorts A and B, either criterion must be met: 1. Motor nerve conduction criteria strongly supportive of demyelination. 2. Motor nerve conduction criteria weakly supportive of demyelination and 2 or more of the following additional diagnostic criteria: * Objective improvement to an empiric trial of therapy with immunoglobulin treatment, plasma exchange (PLEX), or corticosteroids. * Diagnostic imaging by ultrasound or magnetic resonance imaging (MRI) supporting the diagnosis of CIDP by demonstrating nerve enlargement. * Cerebrospinal fluid (CSF) demonstrating albuminocytologic dissociation (i.e., elevated CSF protein level \[defined as \> 70 milligrams per deciliter {mg/dL} or \> 10 mg/dL greater than years of age for those aged 60 years and over\] with normal CSF white blood cell \[WBC\] level). * Nerve biopsy demonstrating features supporting the diagnosis of CIDP, such as edema, demyelination, and/or onion bulb formation. Cohort C only: 4. Have a diagnosis of CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP based on clinical criteria and motor nerve conduction criteria strongly supportive of demyelination (i.e., motor nerve conduction criteria weakly supportive of demyelination is insufficient diagnostic evidence for admission to Cohort C). Cohort D only: 5. Have met only clinical diagnostic criteria for typical CIDP, or one of the following CIDP variants: multifocal CIDP, focal CIDP, or motor CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP. Either inclusion criterion 2(a) or 2(b) must be met. Additional inclusion criteria are defined in the protocol. Exclusion Criteria: All Cohorts: 1. Have current or prior history of immunoglobulin M (IgM) paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies. 2. Have Distal CIDP, Sensory CIDP or are suspected of having a diagnosis of auto-immune nodopathy in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP. 3. Have polyneuropathy of causes other than CIDP including but not limited to: 1. Multifocal motor neuropathy 2. Hereditary demyelinating neuropathy 3. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS) 4. Lumbosacral radiculoplexus neuropathy 5. Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies 6. Drug- or toxin-induced 4. Have diabetes mellitus (DM) and meets any of the following criteria: 1. Does not meet inclusion criteria 2(a) and 3(a). 2. In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP. 3. In the opinion of the Investigator, there is evidence of poorly controlled DM at screening. 5. Have a history of myelopathy or evidence of central demyelination. 6. Are receiving chronic oral corticosteroids monotherapy at a dose \> 40 mg/day prednisolone/prednisone or its equivalent at the Screening Visit. 7. Are receiving chronic oral corticosteroid at a dose \> 10 mg/day prednisolone/prednisone or equivalent in combination with immunoglobulin therapy or PLEX at the Screening Visit. Additional exclusion criteria are defined in the protocol.

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Conditions

The condition(s) this trial relates to.

autoimmune disease chronic inflammatory demyelinating polyradiculoneuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic inflammatory demyelinating polyneuropathy

Contacts and locations

Locations

  • SIte Number - 8400

    Constanța, 900591, Romania

  • Site Number - 1602

    Kansas City, Kansas, 66160, United States

  • Site Number - 1603

    Scottsdale, Arizona, 85028, United States

  • Site Number - 1604

    St. Petersburg, Florida, 33713, United States

  • Site Number - 1605

    New York, New York, 10032, United States

  • Site Number - 1606

    Houston, Texas, 77030, United States

  • Site Number - 1610

    Charlotte, North Carolina, 28207, United States

  • Site Number - 1611

    Nicholasville, Kentucky, 40356, United States

  • Site Number - 1613

    Milwaukee, Wisconsin, 53226-3548, United States

  • Site Number - 1614

    Portland, Oregon, 97239, United States

  • Site Number - 1617

    Ormond Beach, Florida, 32174, United States

  • Site Number - 1620

    Port Charlotte, Florida, 33952, United States

  • Site Number - 1621

    New Haven, Connecticut, 06519, United States

  • Site Number - 1623

    Philadelphia, Pennsylvania, 19104, United States

  • Site Number - 1624

    Philadelphia, Pennsylvania, 19104, United States

  • Site Number - 1625

    Aurora, Colorado, 80045, United States

  • Site Number - 1628

    San Antonio, Texas, 78229, United States

  • Site Number - 1629

    Orlando, Florida, 32806-5411, United States

  • Site Number - 1632

    Seattle, Washington, 98195-0001, United States

  • Site Number - 1633

    Rockledge, Florida, 32955, United States

  • Site Number - 1634

    Los Angeles, California, 90033-5330, United States

  • Site Number - 2600

    Edmonton, Alberta, T6J 1M3, Canada

  • Site Number - 2603

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Site Number - 3201

    Katowice, Silesian Voivodeship, 40-123, Poland

  • Site Number - 3202

    Mazurki, Lublin Voivodeship, 20-093, Poland

  • Site Number - 3203

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Site Number - 3205

    Gdansk, Pomeranian Voivodeship, 80-803, Poland

  • Site Number - 3206

    Lublin, Lublin Voivodeship, 20-701, Poland

  • Site Number - 3207

    Poznan, Greater Poland Voivodeship, 61-731, Poland

  • Site Number - 3208

    Krakow, Lesser Poland Voivodeship, 30-688, Poland

  • Site Number - 3209

    Krakow, Lesser Poland Voivodeship, 31-202, Poland

  • Site Number - 3210

    Lublin, Lublin Voivodeship, 20-064, Poland

  • Site Number - 3211

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065, Poland

  • Site Number - 3241

    Turku, Southwest Finland, 20520, Finland

  • Site Number - 3700

    San Sebastián, Gipuzkoa, 20014, Spain

  • Site Number - 3701

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Site Number - 3703

    Barcelona, 08025, Spain

  • Site Number - 3704

    Sant Cugat del Vallès, Barcelona, 08190, Spain

  • Site Number - 3741

    Lisbon, 1300-344, Portugal

  • Site Number - 3742

    Senhora da Hora, Porto District, 4464-513, Portugal

  • Site Number - 3743

    Almada, Setúbal District, 2805-267, Portugal

  • Site Number - 3744

    Porto, 4099-001, Portugal

  • Site Number - 3745

    Vila Nova de Gaia, Porto District, 4434-502, Portugal

  • Site Number - 4680

    Leuven, Vlaams Brabant, 03000, Belgium

  • Site Number - 4681

    Ghent, Oost-Vlaanderen, 09000, Belgium

  • Site Number - 4740

    Copenhagen, 02100, Denmark

  • Site Number - 4891

    Gothenburg, Västra Götaland County, 413 45, Sweden

  • Site Number - 6300

    Pavia, 27100, Italy

  • Site Number - 6301

    Bergamo, Lombardy, 24127, Italy

  • Site Number - 6302

    Gussago, Brescia, 25084, Italy

  • Site Number - 6303

    Pisa, Tuscany, 56126, Italy

  • Site Number - 6305

    Bologna, Emilia-Romagna, 40139, Italy

  • Site Number - 6306

    Rome, Lazio, 00189, Italy

  • Site Number - 6307

    Milan, Lombardy, 20132, Italy

  • Site Number - 6308

    Siena, Tuscany, 53100, Italy

  • Site Number - 6309

    Rome, Lazio, 00133, Italy

  • Site Number - 6341

    Pátrai, Achaïa, 265 04, Greece

  • Site Number - 6342

    Heraklion, Irakleio, 715 00, Greece

  • Site Number - 6343

    Alexandroupoli, Evros, 68100, Greece

  • Site Number - 6344

    Athens, Attica, 115 25, Greece

  • Site Number - 6345

    Athens, Attica, 115 28, Greece

  • Site Number - 6346

    Ioannina, 455 00, Greece

  • Site Number - 6347

    Larissa, 41110, Greece

  • Site Number - 6491

    Oslo, 00424, Norway

  • Site Number - 6702

    Leipzig, Saxony, 04103, Germany

  • Site Number - 6705

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Site Number - 6706

    Berlin, 10117, Germany

  • Site Number - 7400

    Manchester, M6 8HD, United Kingdom

  • Site Number - 7401

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Site Number - 7402

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • Site Number - 7403

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Site Number - 7404

    Glasgow, Lanarkshire, G51 4TF, United Kingdom

  • Site Number - 7405

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Site Number - 7750

    Buenos Aires, C1199ABB, Argentina

  • Site Number - 7751

    Rosario, Santa Fe Province, S2000DTP, Argentina

  • Site Number - 7752

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Site Number - 7753

    Rosario, Santa Fe Province, S2000BZL, Argentina

  • Site Number - 8401

    Târgu Mureş, Mureș County, 540136, Romania

  • Site Number - 8403

    Timișoara, Timiș County, 300736, Romania

  • Site Number - 8406

    Bucharest, Bucharest, 41914, Romania

  • Site Number - 8500

    Niš, 18000, Serbia

  • Site Number - 8501

    Belgrade, 11000, Serbia

  • Site Number - 8502

    Belgrade, 11000, Serbia

  • Site Number - 8503

    Novi Sad, 21000, Serbia

  • Site Number - 8600

    Liptovský Mikuláš, 031 23, Slovakia

  • Site Number - 8601

    Martin, 036 01, Slovakia

  • Site Number - 8602

    Trnava, 91775, Slovakia

  • Site Number - 8603

    Prešov, 081 81, Slovakia

  • Site Number - 9100

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Site Number - 9101

    Curitiba, Paraná, 81210-310, Brazil

  • Site Number - 9103

    Brasília, Federal District, 70200-730, Brazil

  • Site Number - 9105

    São Paulo, 01409-000, Brazil

  • Site Number - 9110

    Sofia, Sofia-Grad, 01606, Bulgaria

  • Site Number - 9111

    Sofia, Sofia-Grad, 01527, Bulgaria

  • Site Number - 9112

    Pleven, 05800, Bulgaria

  • Site Number - 9900

    Seoul, 06351, South Korea

  • Site Number - 9901

    Seoul, 02841, South Korea

  • Site Number -1601

    Austin, Texas, 78759, United States

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