An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT07188844 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: IMVT-1401-2402
• Study Type: interventional
• Target: 108
• Locations: 11 countries
• Sites: 30

Brief Summary

This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Chronic Inflammatory Demyelinating Polyneuropathy; IMVT-1401; Monoclonal antibody; Autoimmune disorders; Batoclimab

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation

  Up to 52 weeks

Secondary Outcomes (2)

• Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT)

  Up to 52 weeks

• Change from Baseline in Mean Grip Strength

  Up to 52 weeks

Study Arms (1)

Batoclimab

EXPERIMENTAL

Drug: Batoclimab

Interventions

Batoclimab DRUG

Batoclimab 340 mg SC QW

Also known as: IMVT-1401

Batoclimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any participant who has completed Study IMVT-1401-2401
• Female participants of childbearing potential must agree to use a highly effective method of birth control
• Female participants must agree not to donate eggs throughout the study and for 90 days after the final study treatment administration
• Male participants must agree to use 1 highly effective contraception method with partners of childbearing potential throughout the study period and for 90 days after the final study treatment administration
• Male participants must agree not to donate sperm throughout the study period and for 90 days after the final study treatment administration
• Agree not to participate in another interventional study while on treatment

You may not qualify if:

• Participant has any medical condition (acute or chronic illness) or psychiatric condition, including autoimmune disease or neurologic disease other than CIDP, or known history of drug or alcohol abuse that, in the opinion of the Investigator, could jeopardize the participant's ability to participate in this study, compromise accurate assessment of CIDP symptoms or otherwise interfere with the course and conduct of the study.
• Participant intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab
• Participant has an ongoing SAE or a medical condition in the IMVT-1401-2401 study that the Investigator considers putting the participant at a significantly increased risk of participating in Study IMVT-1401-2402
• Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401
• Note: Other protocol specified criteria may apply.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (30)

Site Number - 1621

New Haven, Connecticut, 06519, United States

Location

Site Number - 1617

Ormond Beach, Florida, 32174, United States

Location

Site Number - 1611

Nicholasville, Kentucky, 40356, United States

Location

Site Number - 1610

Charlotte, North Carolina, 28207, United States

Location

Site Number - 1601

Austin, Texas, 78759, United States

Location

Site Number - 7753

Rosario, Santa Fe Province, S2000BZL, Argentina

Location

Site Number - 7751

Rosario, Santa Fe Province, S2000DTP, Argentina

Location

Site Number - 7750

Buenos Aires, C1199ABB, Argentina

Location

Site Number - 7752

San Miguel de Tucumán, T4000AXL, Argentina

Location

Site Number - 4680

Leuven, Vlaams Brabant, 3000, Belgium

Location

Site Number - 9103

Brasília, Federal District, 70200-730, Brazil

Location

Site Number - 9101

Curitiba, Paraná, 81210-310, Brazil

Location

Site Number - 9100

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Site Number - 6702

Leipzig, Saxony, 04103, Germany

Location

Site Number - 6341

Pátrai, Achaïa, 265 04, Greece

Location

Site Number - 6344

Athens, Attica, 115 25, Greece

Location

Site Number - 6347

Larissa, 41110, Greece

Location

Site Number - 6305

Bologna, Emilia-Romagna, 40139, Italy

Location

Site Number - 6309

Rome, Lazio, 00133, Italy

Location

Site Number - 6307

Milan, Lombardy, 20132, Italy

Location

Site Number - 3207

Poznan, Greater Poland Voivodeship, 61-731, Poland

Location

Site Number - 3208

Krakow, Lesser Poland Voivodeship, 30-688, Poland

Location

Site Number - 3209

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

Site Number - 3210

Lublin, Lublin Voivodeship, 20-064, Poland

Location

Site Number - 3206

Lublin, Lublin Voivodeship, 20-701, Poland

Location

Site Number - 3201

Katowice, Silesian Voivodeship, 40-123, Poland

Location

Site Number - 8403

Timișoara, Timiș County, 300736, Romania

Location

Site Number - 8400

Constanța, 900591, Romania

Location

Site Number - 8501

Belgrade, 11000, Serbia

Location

Site Number - 8603

Prešov, 081 81, Slovakia

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); RO (2); SE (1); BE (1); BR (3); AR (4); SL (1); DE (1); GR (3); US (5); PL (6)