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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
argenx
Study ID
NCT07091630
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

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

Interventions

  • Empasiprubart IV — BIOLOGICAL
    Intravenous infusion of empasiprubart
  • Placebo IV — OTHER
    Intravenous infusion of placebo

Study Details

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

Key Dates

First listed
Jul 29, 2025
Start date
Sep 16, 2025
Status verified
May 2026
Primary completion
Oct 7, 2027
Completion
Jan 23, 2031

Study Design

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

Arms

  • Experimental: Part A - Empasiprubart
    Participants receive empasiprubart during part A
  • Placebo Comparator: Part A - Placebo
    Participants receive placebo during part A
  • 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.

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 (10)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham - 1720 University BlvdBirminghamAlabama35233-
Samir Macwan, M.D., Inc. (S corporation)Rancho MirageCalifornia92270
Samir Macwan, MD
[email protected]; [email protected]
760-834-3540
Colorado Springs Neurological AssociatesColorado SpringsColorado80907
David Stevens, MD
[email protected]
719-389-1159
Medstar Health Research InstituteWashington D.C.District of Columbia20010
Nicholas Streicher, MD
[email protected]
646-797-8917
Gables NeurologyMiamiFlorida33133
Andrew Lerman, MD
[email protected]
954-243-5559
Aqualane Clinical ResearchNaplesFlorida34105
Matthew Baker, MD
[email protected]
650-723-6961
Paradigm Health SystemSlidellLouisiana70458
Patrick Glynn, MD
[email protected]
985-882-4500
Penn Medicine University CityPhiladelphiaPennsylvania19104-5545
Sami Khella, MD
[email protected]
215-662-8870
National Neuromuscular Research InstituteAustinTexas78756
Yessar Hussain, MD
[email protected]
512-920-0140
NeuroCarePlusHoustonTexas77094
Nicolas Nammour, MD
[email protected]
281-579-6800

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham - 1720 University Blvd· Birmingham, ALSamir Macwan, M.D., Inc. (S corporation)· Rancho Mirage, CAColorado Springs Neurological Associates· Colorado Springs, COMedstar Health Research Institute· Washington D.C., DCGables Neurology· Miami, FLAqualane Clinical Research· Naples, FL

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