A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
NCT ID: NCT06920004
Last Updated: 2026-02-09
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
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RECRUITING
PHASE3
218 participants
INTERVENTIONAL
2025-08-22
2030-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A - empasiprubart + IVIg-placebo
During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
empasiprubart
Intravenous infusion of empasiprubart
IVIg-placebo
A placebo resembling the IVIg treatment
Part A - IVIg + empasiprubart-placebo
During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.
IVIg
Intravenous infusion of IVIg
empasiprubart-placebo
A placebo resembling the empasiprubart treatment
Part B - empasiprubart
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.
empasiprubart
Intravenous infusion of empasiprubart
empasiprubart-placebo
A placebo resembling the empasiprubart treatment
Interventions
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empasiprubart
Intravenous infusion of empasiprubart
IVIg
Intravenous infusion of IVIg
empasiprubart-placebo
A placebo resembling the empasiprubart treatment
IVIg-placebo
A placebo resembling the IVIg treatment
Eligibility Criteria
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Inclusion Criteria
* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
* Has responded to IVIg in the past 5 years
* Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
* Has residual disability and active disease
Exclusion Criteria
* Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
* Use of other long-acting immunomodulatory treatment
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Homestead Associates in Research Inc
Homestead, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Paradigm Health System
Slidell, Louisiana, United States
Erlanger Health System
Columbia, Maryland, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
NeuroCarePlus
Houston, Texas, United States
National Neuromuscular Research Institute
Irving, Texas, United States
Astra Kliinik
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Chiba University Hospital
Chūōku, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
General Hospital Tsuchiura Kyodo Hospital
Tsuchiura, , Japan
Neurocentrum Bydgoszcz
Bydgoszcz, , Poland
Centrum Medyczne Neurologia Slaska
Katowice, , Poland
Centrum Medyczne Linden
Krakow, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
ULS de Santo António, EPE - Hospital de Santo António
Porto, , Portugal
Institutul National de Neurologie si Boli Neurovasculare Bucuresti
Bucharest, , Romania
Univerzitna nemocnica MARTIN
Martin, , Slovakia
Inje University Haeundae Paik Hospital
Busan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Sant Andreu de la Barca, , Spain
Hôpitaux Universitaires de Genève (HUG)
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-520097-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-117-2401
Identifier Type: -
Identifier Source: org_study_id
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