To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP
NCT ID: NCT05581199
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
277 participants
INTERVENTIONAL
2022-12-15
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work
NCT06290128
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
NCT07091630
Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain
NCT04476108
Efficacy and Safety Study of I10E in Treatment of Patients With CIDP
NCT02293460
Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT00603265
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Period 1: Cohort A, Dose 1
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Treatment Period 1: Cohort A, Dose 2
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Treatment Period 1: Cohort B, Dose 1
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Treatment Period 1: Cohort B, Dose 2
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Treatment Period 1: Cohort C, Dose 1
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Treatment Period 1: Cohort C, Dose 2
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Treatment Period 1: Cohort D, Dose 1
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Treatment Period 1: Cohort D, Dose 2
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Withdrawal Period 2: Cohort A, Dose 2
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Withdrawal Period 2: Cohort A, Placebo
Placebo
Matching placebo SC
Withdrawal Period 2: Cohort B, Dose 2
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Withdrawal Period 2: Cohort B, Placebo
Placebo
Matching placebo SC
Withdrawal Period 2: Cohort C, Dose 2
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Withdrawal Period 2: Cohort C, Placebo
Placebo
Matching placebo SC
Withdrawal Period 2: Cohort D, Dose 2
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Withdrawal Period 2: Cohort D, Placebo
Placebo
Matching placebo SC
LTE Period: With Relapse in Period 2: Dose 1 and Dose 2
Participants will receive Dose 1 for the initial 4 weeks only and Dose 2 for the remaining 48 weeks.
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
LTE Period: Without Relapse in Period 2: Dose 2
Participants will receive Dose 2 for all 52 weeks.
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Placebo
Matching placebo SC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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.
Exclusion Criteria
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:
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Immunovant Sciences GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IMVT-1401-2401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.