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2024-512646-42-00CompletedPhase 2

Phase 2b Study to Assess Efficacy and Safety of Batoclimab in Adult Participants with Active CIDP.

A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Oct 2025

Next steps

Brief summary (registry, in English)

Period 2/ Cohort A: To evaluate the efficacy of batoclimab compared to placebo in maintaining clinical response as assessed by adjusted inflammatory neuropathy cause and treatment (Adj INCAT) score in participants receiving immune globulin (IVIg or SCIg) or plasma exchange (PLEX) treatment for CIDP at the time of screening.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
178 (actual)
First submitted
24 Jul 2024
Start date
27 Jun 2023
Lead sponsor
Immunovant Sciences GmbH
EU CT number
2024-512646-42-00
EudraCT number
2022-002718-17

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 178
  • 54 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have current or prior history of immunoglobulin M (IgM) paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.
  • Are receiving chronic oral corticosteroids monotherapy at a dose > 40 mg/day prednisolone/prednisone or its equivalent at the Screening Visit.
  • 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.

Other illness

  • Have polyneuropathy of causes other than CIDP including but not limited to: a. Multifocal motor neuropathy b. Hereditary demyelinating neuropathy c. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS) d. Lumbosacral radiculoplexus neuropathy e. Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies f. Drug- or toxin-induced
  • Have diabetes mellitus (DM) and meets any of the following criteria: a. Does not meet inclusion criteria 2(a) and 3(a) b. In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP. c. 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.

Other

  • 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.
  • Additional exclusion criteria are defined in the protocol.

Who the study is looking for

  • Are >= 18 years at the Screening Visit.
  • 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 the Diagnosis and Treatment of CIDP. Clinical criteria for typical CIDP and variants are as follows (either criteria must be met): a. 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 b. 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 - Have electrodiagnostic test results supporting the diagnosis of CIDP in accordance with the EAN/PNS Guideline on the Diagnosis and Treatment of CIDP (either criteria must be met): a. Motor nerve conduction criteria strongly supportive of demyelination. b. 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 more than 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: 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: 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (54)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universiteit GentGentBelgiumCompleted
UZ LeuvenLeuvenBelgiumCompleted
Military Medical Academy - Multiprofile Hospital for Active Treatment - PlevenPlevenBulgariaCompleted
Diagnostic-Consultative Center Convex EOODSofiaBulgariaCompleted
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I PirogovSofiyaBulgariaCompleted
Charité Campus MitteBerlinGermanyCompleted
Katholisches Klinikum Bochum gGmbHBochumGermanyCompleted
Universitaet LeipzigLeipzigGermanyCompleted
RigshospitaletCopenhagen OeDenmarkCompleted
Catalunya General HospitalBarcelonaSpainCompleted
Hospital Santa Creu i Sant PauBarcelonaSpainCompleted
Bellvitge University HospitalL'hospitalet De LlobregatSpainCompleted
Turku University HospitalTurkuFinlandCompleted
University General Hospital of AlexandroupoliAlexandroupoliGreeceCompleted
Eginitio HospitalAthensGreeceCompleted
401 General Military Hospital of AthensAthensGreeceCompleted
University General Hospital of HeraklionHeraklionGreeceCompleted
University General Hospital of IoanninaIoanninaGreeceCompleted
General University Hospital of LarissaLarissaGreeceCompleted
General University Hospital Of PatrasPatrasGreeceCompleted
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamoItalyCompleted
Azienda Unita Sanitaria Locale Di BolognaBolognaItalyCompleted
Fondazione Serena ONLUS Centro Clinico NEMO BresciaBresciaItalyCompleted
San Raffaele OspedaleMilanoItalyCompleted
Fondazione Istituto Neurologico Mondino IRCCS [Istituto di Ricovero e Cura a Carattere Scientifico]PaviaItalyCompleted
Azienda Ospedaliero Universitaria PisanaPisaItalyCompleted
Fondazione PTV - POLICLINICO TOR VERGATARomaItalyCompleted
Azienda Ospedaliero-Universitaria Sant AndreRomeItalyCompleted
Azienda Ospedaliera Universitaria SeneseSienaItalyCompleted
Oslo University Hospital HFOsloNorwayCompleted
Medicover Integrated Clinical Services Sp. z o.o.BydgoszczPolandCompleted
Neurocentrum Bydgoszcz sp. z o.oBydgoszczPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracowPolandCompleted
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla IICracowPolandCompleted
Copernicus Podmiot Leczniczy Sp. z o.oGdanskPolandCompleted
Neurologia Śląska Centrum MedyczneKatowicePolandCompleted
Centrum Medyczne Hope Clinic Sebastian SzklenerLublinPolandCompleted
Galen ClinicLublinPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.LublinPolandCompleted
Clinical Research Center Sp z o o Medic R Sp kPoznanPolandCompleted
Unidade Local De Saude De Almada-Seixal E.P.E.AlmadaPortugalCompleted
Unidade Local De Saude Lisboa Ocidental E.P.E.LisbonPortugalCompleted
Unidade Local De Saude De Santo Antonio E.P.E.PortoPortugalCompleted
Unidade Local De Saude De Matosinhos E.P.E.Senhora Da HoraPortugalCompleted
Unidade Local de Saúde de Gaia/Espinho, E. P. EVila Nova de GaiaPortugalCompleted
Institutul National de Neurologie si Boli Neurovasculare BucurestiBucharestRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei ConstantaConstanțaRomaniaCompleted
Spitalul Clinic Judetean de Urgenta Targu MuresTârgu MureşRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Pius Brinzeu TimisoaraTimisoaraRomaniaCompleted
Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborgSwedenCompleted
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky MikulasLiptovský MikulášSlovakiaCompleted
Univerzitna nemocnica MartinMartinSlovakiaCompleted
Fakultna nemocnica s poliklinikou J.A. Reimana PresovPrešovSlovakiaCompleted
Fakultna nemocnica TrnavaTrnavaSlovakiaCompleted

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