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

argenx

Status and phase: Enrolling; Phase 3

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; CIDP; Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Treatments: Other: Placebo IV; Biological: Empasiprubart IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT07091630

2025-520805-10-00 (EU Trial (CTIS) Number)

ARGX-117-2402

Details and patient eligibility

About

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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 3 patient groups, including a placebo group

Part A - Empasiprubart

Experimental group

Description:

Participants receive empasiprubart during part A

Treatment:

Biological: Empasiprubart IV

Part A - Placebo

Placebo Comparator group

Description:

Participants receive placebo during part A

Treatment:

Other: Placebo IV

Part B - Empasiprubart

Experimental group

Description:

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.

Treatment:

Biological: Empasiprubart IV