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ACTIVE NOT RECRUITING

NCT05581199

PHASE2

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

Sponsor: Immunovant Sciences GmbH

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin \[Ig\] or plasma exchange \[PLEX\]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

277

Start Date

2022-12-15

Completion Date

2027-01

Last Updated

2024-11-25

Healthy Volunteers

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

DRUG

Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

DRUG

Batoclimab 340 mg SC weekly

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

DRUG

Placebo

Matching placebo SC

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.

Locations (116)

Site Number - 1603

Scottsdale, Arizona, United States

Site Number - 1618

Carlsbad, California, United States

Site Number - 1634

Los Angeles, California, United States

Site Number - 1619

Orange, California, United States

Site Number - 1608

San Francisco, California, United States

Site Number - 1625

Aurora, Colorado, United States

Site Number - 1636

Fort Collins, Colorado, United States

Site Number - 1621

New Haven, Connecticut, United States

Site Number - 1630

Washington D.C., District of Columbia, United States

Site Number - 1600

Boca Raton, Florida, United States

Site Number - 1609

Jacksonville, Florida, United States

Site Number - 1631

Orlando, Florida, United States

Site Number - 1629

Orlando, Florida, United States

Site Number - 1617

Ormond Beach, Florida, United States

Site Number - 1620

Port Charlotte, Florida, United States

Site Number - 1633

Rockledge, Florida, United States

Site Number - 1604

St. Petersburg, Florida, United States

Site Number - 1607

O'Fallon, Illinois, United States

Site Number - 1602

Kansas City, Kansas, United States

Site Number - 1611

Nicholasville, Kentucky, United States

Site Number - 1622

Brooklyn, New York, United States

Site Number - 1605

New York, New York, United States

Site Number - 1635

Chapel Hill, North Carolina, United States

Site Number - 1610

Charlotte, North Carolina, United States

Site Number - 1614

Portland, Oregon, United States

Site Number - 1623

Philadelphia, Pennsylvania, United States

Site Number - 1624

Philadelphia, Pennsylvania, United States

Site Number -1601

Austin, Texas, United States

Site Number - 1606

Houston, Texas, United States

Site Number - 1628

San Antonio, Texas, United States

Site Number - 1627

Richmond, Virginia, United States

Site Number - 1632

Seattle, Washington, United States

Site Number - 1613

Milwaukee, Wisconsin, United States

Site Number - 7753

Rosario, Santa Fe Province, Argentina

Site Number - 7751

Rosario, Santa Fe Province, Argentina

Site Number - 7752

San Miguel de Tucumán, Tucumán Province, Argentina

Site Number - 7750

Buenos Aires, Argentina

Site Number - 4681

Ghent, Oost-Vlaanderen, Belgium

Site Number - 4680

Leuven, Vlaams Brabant, Belgium

Site Number - 9103

Brasília, Federal District, Brazil

Site Number - 9101

Curitiba, Paraná, Brazil

Site Number - 9100

Ribeirão Preto, São Paulo, Brazil

Site Number - 9102

Rio de Janeiro, Brazil

Site Number - 9105

São Paulo, Brazil

Site Number - 9111

Sofia, Sofia-Grad, Bulgaria

Site Number - 9110

Sofia, Sofia-Grad, Bulgaria

Site Number - 9112

Pleven, Bulgaria

Site Number - 2600

Edmonton, Alberta, Canada

Site Number - 2603

Vancouver, British Columbia, Canada

Site Number - 4740

Copenhagen, Denmark

Site Number - 3241

Turku, Southwest Finland, Finland

Site Number - 6704

München, Bavaria, Germany

Site Number - 6705

Bochum, North Rhine-Westphalia, Germany

Site Number - 6700

Dresden, Saxony, Germany

Site Number - 6702

Leipzig, Saxony, Germany

Site Number - 6706

Berlin, Germany

Site Number - 6341

Pátrai, Achaïa, Greece

Site Number - 6344

Athens, Attica, Greece

Site Number - 6345

Athens, Attica, Greece

Site Number - 6343

Alexandroupoli, Evros, Greece

Site Number - 6346

Ioannina, Ioannina, Greece

Site Number - 6342

Heraklion, Irakleio, Greece

Site Number - 6347

Larissa, Greece

Site Number - 6302

Gussago, Brescia, Italy

Site Number - 6305

Bologna, Emilia-Romagna, Italy

Site Number - 6304

Udine, Friuli Venezia Giulia, Italy

Site Number - 6309

Rome, Lazio, Italy

Site Number - 6306

Rome, Lazio, Italy

Site Number - 6301

Bergamo, Lombardy, Italy

Site Number - 6307

Milan, Lombardy, Italy

Site Number - 6303

Pisa, Tuscany, Italy

Site Number - 6308

Siena, Tuscany, Italy

Site Number - 6300

Pavia, Italy

Site Number - 6491

Oslo, Norway

Site Number - 3207

Poznan, Greater Poland Voivodeship, Poland

Site Number - 3211

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Number - 3203

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Number - 3208

Krakow, Lesser Poland Voivodeship, Poland

Site Number - 3209

Krakow, Lesser Poland Voivodeship, Poland

Site Number - 3200

Krakow, Lesser Poland Voivodeship, Poland

Site Number - 3204

Wroclaw, Lower Silesian Voivodeship, Poland

Site Number - 3210

Lublin, Lublin Voivodeship, Poland

Site Number - 3206

Lublin, Lublin Voivodeship, Poland

Site Number - 3202

Mazurki, Lublin Voivodeship, Poland

Site Number - 3205

Gdansk, Pomeranian Voivodeship, Poland

Site Number - 3201

Katowice, Silesian Voivodeship, Poland

Site Number - 3742

Senhora da Hora, Porto District, Portugal

Site Number - 3745

Vila Nova de Gaia, Porto District, Portugal

Site Number - 3743

Almada, Setúbal District, Portugal

Site Number - 3741

Lisbon, Portugal

Site Number - 3744

Porto, Portugal

Site Number - 8406

Bucharest, București, Romania

Site Number - 8401

Târgu Mureş, Mureș County, Romania

Site Number - 8403

Timișoara, Timiș County, Romania

SIte Number - 8400

Constanța, Romania

Site Number - 8501

Belgrade, Serbia

Site Number - 8502

Belgrade, Serbia

Site Number - 8500

Niš, Serbia

Site Number - 8503

Novi Sad, Serbia

Site Number - 8600

Liptovský Mikuláš, Slovakia

Site Number - 8601

Martin, Slovakia

Site Number - 8603

Prešov, Slovakia

Site Number - 8602

Trnava, Slovakia

Site Number - 9901

Seoul, South Korea

Site Number - 9900

Seoul, South Korea

Site Number - 3701

L'Hospitalet de Llobregat, Barcelona, Spain

Site Number - 3704

Sant Cugat del Vallès, Barcelona, Spain

Site Number - 3700

San Sebastián, Gipuzkoa, Spain

Site Number - 3703

Barcelona, Spain

Site Number - 4891

Gothenburg, Västra Götaland County, Sweden

Site Number - 7405

Cambridge, Cambridgeshire, United Kingdom

Site Number - 7402

Southampton, Hampshire, United Kingdom

Site Number - 7404

Glasgow, Lanarkshire, United Kingdom

Site Number - 7403

Preston, Lancashire, United Kingdom

Site Number - 7401

Sheffield, South Yorkshire, United Kingdom

Site Number - 7400

Manchester, United Kingdom

Clinical Research Directory

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (116)