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

Part of paid clinical trials in Rancho Mirage, California.

Sponsor
argenx
Study ID
NCT06920004
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • CIDP
  • CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
  • Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • empasiprubart — BIOLOGICAL
    Intravenous infusion of empasiprubart
  • IVIg — BIOLOGICAL
    Intravenous infusion of IVIg
  • empasiprubart-placebo — OTHER
    A placebo resembling the empasiprubart treatment
  • IVIg-placebo — OTHER
    A placebo resembling the IVIg treatment

Study Details

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). More information can be found here: https://clinicaltrials.argenx.com/emvigorate

Key Dates

Start date
Aug 22, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2030

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - empasiprubart + IVIg-placebo
    During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
  • Active Comparator: Part A - IVIg + empasiprubart-placebo
    During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.
  • Experimental: Part B - empasiprubart
    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.

Primary Outcome Measure

Reduction of ≥1 point compared with baseline in aINCAT score at week 24 [ Time Frame: up to 24 weeks ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Samir Macwan, M.D., Inc.Rancho MirageCalifornia922701
Samir Macwan, MD
[email protected]
760-531-4068
Colorado Springs Neurological AssociatesColorado SpringsColorado80907
David Stevens, MD
[email protected]
719-473-3272
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Nicholas Streicher, MD
[email protected]
646-797-8917
Homestead Associates in Research IncHomesteadFlorida33033
Christopher Jimenez, MD
[email protected]
305-246-0873
Visionary Investigators NetworkMiamiFlorida33133
Andrew Lerman, MD
[email protected]
786-655-8010
University of South FloridaTampaFlorida33616
Kathleen Murray, MD
[email protected]
813-974-9713
Paradigm Health SystemSlidellLouisiana70458
Patrick Glynn, MD
[email protected]
985-882-4500
Erlanger Health SystemColumbiaMaryland21044
Joshua Alpers, MD
[email protected]
423-778-9001
University of Michigan HospitalAnn ArborMichigan48109
Amro Stino, MD
[email protected]
734-936-8586
NeuroCarePlusHoustonTexas77094
Nicolas Nammour, MD
[email protected]
281-579-6800
National Neuromuscular Research InstituteIrvingTexas75063
Yessar Hussain, MD
[email protected]
512-920-0140

Find similar trials in Rancho Mirage, CA

By research site
Samir Macwan, M.D., Inc.· Rancho Mirage, CAColorado Springs Neurological Associates· Colorado Springs, COMedStar Washington Hospital Center· Washington D.C., DCHomestead Associates in Research Inc· Homestead, FLVisionary Investigators Network· Miami, FLUniversity of South Florida· Tampa, FL

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