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

Purpose

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).

Conditions

  • Chronic Inflammatory Demyelinating Polyneuropathy
  • CIDP
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A - Empasiprubart 		Participants receive empasiprubart during part A
  • Biological: Empasiprubart IV
    Intravenous infusion of empasiprubart
Placebo Comparator
Part A - Placebo 		Participants receive placebo during part A
  • Other: Placebo IV
    Intravenous infusion of placebo
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.
  • Biological: Empasiprubart IV
    Intravenous infusion of empasiprubart

Recruiting Locations

Colorado Springs Neurological Associates
Colorado Springs 5417598, Colorado 5417618 80907
Contact:
David Stevens, MD
857-350-4834
clinicaltrials@argenx.com

Gables Neurology
Miami 4164138, Florida 4155751 33133
Contact:
Andrew Lerman, MD
857-350-4834
clinicaltrials@argenx.com

Paradigm Health System
Slidell 4341727, Louisiana 4331987 70458
Contact:
Patrick Glynn, MD
857-350-4834
clinicaltrials@argenx.com

National Neuromuscular Research Institute
Austin 4671654, Texas 4736286 78756
Contact:
Yessar Hussain, MD
857-350-4834
clinicaltrials@argenx.com

NeuroCarePlus
Houston 4699066, Texas 4736286 77094
Contact:
Nicolas Nammour, MD
857-350-4834
clinicaltrials@argenx.com

More Details

Status
Recruiting
Sponsor
argenx

Study Contact

Sabine Coppieters, MD
857-350-4834
clinicaltrials@argenx.com