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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Immunovant Sciences GmbH
Study ID
NCT07188844
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 28, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Batoclimab

Primary Outcome Measure

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 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Site Number - 1621New HavenConnecticut06519-
Site Number - 1617Ormond BeachFlorida32174-
Site Number - 1611NicholasvilleKentucky40356-
Site Number - 1610CharlotteNorth Carolina28207-
Site Number - 1601AustinTexas78759-

Find similar trials in New Haven, CT

By research site
Site Number - 1621· New Haven, CTSite Number - 1617· Ormond Beach, FLSite Number - 1611· Nicholasville, KYSite Number - 1610· Charlotte, NCSite Number - 1601· Austin, TX

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