A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP (emvigorate)

argenx

Status and phase: Enrolling; Phase 3

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

Treatments: Biological: empasiprubart; Other: empasiprubart-placebo; Other: IVIg-placebo; Biological: IVIg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06920004

ARGX-117-2401

2024-520097-36-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Enrollment: 218 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, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 3 patient groups

Part A - empasiprubart + IVIg-placebo

Experimental group

Description:

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

Treatment:

Other: IVIg-placebo

Biological: empasiprubart

Part A - IVIg + empasiprubart-placebo

Active Comparator group

Description:

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

Treatment:

Biological: IVIg

Other: empasiprubart-placebo

Part B - empasiprubart

Experimental group

Description:

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.

Treatment:

Other: empasiprubart-placebo

Biological: empasiprubart