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TerminatedNCT07188844Updated Aug 11, 2026

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

A Phase 2 interventional study of Batoclimab in Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Immunovant Sciences GmbH. Terminated at 30 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Immunovant Sciences GmbH · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor Decision
Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

  • Chronic Inflammatory Demyelinating Polyneuropathy
  • IMVT-1401
  • Monoclonal antibody
  • Autoimmune disorders
  • Batoclimab
03

In context

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

129 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 49 are open to participants now.

This study's enrollment of 26 is below the median of 40 across 82 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Lead sponsor

Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Batoclimab

    Drug: Batoclimab

Interventions

  • DrugBatoclimab

    Batoclimab 340 mg SC QW

    Also known as: IMVT-1401

06

What researchers measure

Primary outcomes

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

    Time frame: Up to 52 weeks

Secondary outcomes

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

    The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP and will be used for measurement of clinical response.

    Time frame: Up to 52 weeks

  2. Change from Baseline in Mean Grip Strength

    Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment.

    Time frame: Up to 52 weeks

07

Study locations

30 sites
  • Site Number - 1621
    New Haven, Connecticut 06519, United States
  • Site Number - 1617
    Ormond Beach, Florida 32174, United States
  • Site Number - 1611
    Nicholasville, Kentucky 40356, United States
  • Site Number - 1610
    Charlotte, North Carolina 28207, United States
  • Site Number - 1601
    Austin, Texas 78759, United States
  • Site Number - 7753
    Rosario, Santa Fe Province S2000BZL, Argentina
  • Site Number - 7751
    Rosario, Santa Fe Province S2000DTP, Argentina
  • Site Number - 7750
    Buenos Aires, C1199ABB, Argentina
  • Site Number - 7752
    San Miguel de Tucumán, T4000AXL, Argentina
  • Site Number - 4680
    Leuven, Vlaams Brabant 3000, Belgium
  • Site Number - 9103
    Brasília, Federal District 70200-730, Brazil
  • Site Number - 9101
    Curitiba, Paraná 81210-310, Brazil
  • Site Number - 9100
    Ribeirão Preto, São Paulo 14048-900, Brazil
  • Site Number - 6702
    Leipzig, Saxony 04103, Germany
  • Site Number - 6341
    Pátrai, Achaïa 265 04, Greece
  • Site Number - 6344
    Athens, Attica 115 25, Greece
  • Site Number - 6347
    Larissa, 41110, Greece
  • Site Number - 6305
    Bologna, Emilia-Romagna 40139, Italy
  • Site Number - 6309
    Rome, Lazio 00133, Italy
  • Site Number - 6307
    Milan, Lombardy 20132, Italy
  • 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 - 3206
    Lublin, Lublin Voivodeship 20-701, Poland
  • Site Number - 3201
    Katowice, Silesian Voivodeship 40-123, Poland
  • Site Number - 8403
    Timișoara, Timiș County 300736, Romania
  • Site Number - 8400
    Constanța, 900591, Romania
  • Site Number - 8501
    Belgrade, 11000, Serbia
  • Site Number - 8603
    Prešov, 081 81, Slovakia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07188844
Lead sponsor
Immunovant Sciences GmbH
Responsible party
Sponsor
First posted
Sep 23, 2025
Start date
Aug 28, 2025
Primary completion
Jul 16, 2026
Completion
Jul 16, 2026
Last update
Aug 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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