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

NCT07091630 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: ARGX-117-24022025-520805-10-00
• Study Type: interventional
• Target: 160
• Locations: 5 countries
• Sites: 19

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

Outcome Measures

Primary Outcomes (1)

• Reduction of ≥1 point compared with baseline in aINCAT score at week 24

  The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

  Up to 24 weeks

Secondary Outcomes (22)

• Change from baseline in I-RODS centile points score

  Up to 24 weeks (part A) + 96 weeks (Part B)

• Change from baseline in MRC-SS at week 24

  Up to 24 weeks

• Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24

  Up to 24 weeks

• Time to reduction of ≥1 point from baseline in aINCAT score

  Up to 24 weeks

• Change from baseline in TUG

  Up to 24 weeks (part A) + 96 weeks (Part B)

Study Arms (3)

Part A - Empasiprubart

EXPERIMENTAL

Participants receive empasiprubart during part A

Biological: Empasiprubart IV

Part A - Placebo

PLACEBO COMPARATOR

Participants receive placebo during part A

Other: Placebo IV

Part B - Empasiprubart

EXPERIMENTAL

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.

Biological: Empasiprubart IV

Interventions

Empasiprubart IV BIOLOGICAL

Intravenous infusion of empasiprubart

Part A - Empasiprubart; Part B - Empasiprubart

Placebo IV OTHER

Intravenous infusion of placebo

Part A - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

Study Sites (19)

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

RECRUITING

Medstar Health Research Institute

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

RECRUITING

Gables Neurology

Miami, Florida, 33133, United States

RECRUITING

Paradigm Health System

Slidell, Louisiana, 70458, United States

RECRUITING

National Neuromuscular Research Institute

Austin, Texas, 78756, United States

RECRUITING

NeuroCarePlus

Houston, Texas, 77094, United States

RECRUITING

Peking University First Hospital - Changqiao Campus

Beijing, 100034, China

RECRUITING

Nanfang Hospital Southern Medical University

Guangzhou, 510515, China

RECRUITING

High Technology Hospital MedCenter Ltd

Batumi, 6000, Georgia

RECRUITING

First Medical Clinic LLC

Batumi, Georgia

RECRUITING

Petre Sarajishvili Institute of Neurology

Tbilisi, 0112, Georgia

RECRUITING

Aleksandre Aladashvili Clinic

Tbilisi, 102, Georgia

RECRUITING

Curatio JSC

Tbilisi, 114, Georgia

RECRUITING

LTD New Hospitals

Tbilisi, 114, Georgia

RECRUITING

Geo Hospitals

Tbilisi, 144, Georgia

RECRUITING

Jo Ann Medical Center

Tbilisi, 159, Georgia

RECRUITING

Southern TOHOKU Medical Clinic

Kōriyama, 963-8052, Japan

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): October 7, 2027
• Study Completion (Estimated): January 23, 2031
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2); JP (1); GE (8); CN (2); US (6)