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

NCT07188844 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-12-26

No results posted yet for this 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.

Conditions

Interventions

DRUG

Batoclimab

Batoclimab 340 mg SC QW

Sponsors & Collaborators

  • Immunovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Germany
  • Greece
  • Italy
  • Poland
  • Romania
  • Serbia
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188844 on ClinicalTrials.gov