Recruiting

Phase 3

Empasiprubart vs. IVIgA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

Sponsor:

argenx

Code:

NCT06920004

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

CIDP

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

empasiprubart

IVIg

empasiprubart-placebo

IVIg-placebo

Study Details

Brief summary:

The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).

More information can be found here: https://clinicaltrials.argenx.com/emvigorate

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

CIDP

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Study ID

NCT06920004

Start date

Aug 22, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
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:

Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes
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

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A - empasiprubart + IVIg-placebo

During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.

active comparator: Part A - IVIg + empasiprubart-placebo

During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.

experimental: 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.

Interventions

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

Primary outcome measure

Reduction of ≥1 point compared with baseline in aINCAT score at week 24 [ Time Frame: up to 24 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834 clinicaltrials@argenx.com

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Eroboghene Ubogu, MD

857-350-4834 ubogu@uab.edu

Samir Macwan, M.D., Inc.

Recruiting

Rancho Mirage, California, United States, 922701

Contacts

Samir Macwan, MD

760-531-4068 samirmacwan@gmail.com

Colorado Springs Neurological Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

David Stevens, MD

719-473-3272 dstevens@csneuro.com

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Yasir Al-Khalili, MD

857-350-4834 clinicaltrials@argenx.com

Homestead Associates in Research Inc

Recruiting

Homestead, Florida, United States, 33033

Contacts

Christopher Jimenez, MD

305-246-0873 cjimenez@associatesinresearch.com

Visionary Investigators Network

Recruiting

Miami, Florida, United States, 33133

Contacts

Andrew Lerman, MD

786-655-8010 alerman@fcneurology.net

University of South Florida

Recruiting

Tampa, Florida, United States, 33616

Contacts

Kathleen Murray, MD

813-974-9713 kmurray11@usf.edu

Paradigm Health System

Recruiting

Slidell, Louisiana, United States, 70458

Contacts

Patrick Glynn, MD

985-882-4500 trickpatglynn@yahoo.com

Erlanger Health System

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Joshua Alpers, MD

423-778-9001 joshua.alpers@erlanger.org

University of Michigan Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Amro Stino, MD

734-936-8586 amstino@umich.edu

Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104-5127

Contacts

Michael Baer, MD

857-350-4834 clinicaltrials@argenx.com

Jefferson Health Honickman Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Goran Rakocevic, MD

857-350-4834 clinicaltrials@argenx.com

NeuroCarePlus

Recruiting

Houston, Texas, United States, 77094

Contacts

Nicolas Nammour, MD

281-579-6800 nicolas.nammour@sclamanagement.com

National Neuromuscular Research Institute

Recruiting

Irving, Texas, United States, 75063

Contacts

Yessar Hussain, MD

512-920-0140 yessar@austinneuromuscle.com

More Information

Sponsor

argenx

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by argenx on 2026-08-26.