Recruiting

Phase 3

EmpasiprubartA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

Sponsor:

argenx

Code:

NCT07091630

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

CIDP

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empasiprubart IV

Placebo IV

Study Details

Brief summary:

The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo 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/emnergize

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

CIDP

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Study ID

NCT07091630

Start date

Sep 16, 2025

Status verified date

Aug, 2026

Completion date

Jan 23, 2031

Anticipated

Primary completion date

Oct 7, 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 (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
Has residual disability and active disease
Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP

Exclusion Criteria:

Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
Sensory CIDP (including sensory-predominant CIDP)
Polyneuropathy of other causes
Clinical diagnosis of systemic lupus erythematosus (SLE)
Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A - Empasiprubart

Participants receive empasiprubart during part A

placebo comparator: Part A - Placebo

Participants receive placebo during part A

experimental: Part B - Empasiprubart

Participants receive empasiprubart during part B. Participants from the empasiprubart arm in part A will receive placebo once to maintain the blind of part A.

Interventions

Empasiprubart IV

Intravenous infusion of empasiprubart

Placebo IV

Intravenous infusion of placebo

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

Samir Macwan, M.D., Inc. (S corporation)

Recruiting

Rancho Mirage, California, United States, 92270

Contacts

Samir Macwan, MD

760-834-3540 smacwan@southlandneuromuscular.com; samirmacwan@gmail.com

Colorado Springs Neurological Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

David Stevens, MD

719-389-1159 dstevens@csneuro.com

Medstar Health Research Institute

Recruiting

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

Contacts

Yasir Al-Khalili, MD

857-350-4834 yasir.al-khalili@medstar.net

Gables Neurology

Recruiting

Miami, Florida, United States, 33133

Contacts

Andrew Lerman, MD

954-243-5559 alerman@fcneurology.net

Aqualane Clinical Research

Recruiting

Naples, Florida, United States, 34105

Contacts

Matthew Baker, MD

650-723-6961 Matthew@aqualaneresearch.com

Paradigm Health System

Recruiting

Slidell, Louisiana, United States, 70458

Contacts

Patrick Glynn, MD

985-882-4500 trickpatglynn@yahoo.com

Penn Medicine University City

Recruiting

Philadelphia, Pennsylvania, United States, 19104-5545

Contacts

Sami Khella, MD

215-662-8870 sami.khella@pennmedicine.upenn.edu

Jefferson Health Honickman Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Goran Rakocevic, MD

857-350-4834 clinicaltrials@argenx.com

National Neuromuscular Research Institute

Recruiting

Austin, Texas, United States, 78756

Contacts

Yessar Hussain, MD

512-920-0140 yessar@austinneuromuscle.com

NeuroCarePlus

Recruiting

Houston, Texas, United States, 77094

Contacts

Nicolas Nammour, MD

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

More Information

Sponsor

argenx

Last update posted

Aug 21, 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 2026-08-21.