A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
argenx · NCT07091630
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 160
- US sites recruiting
- 13
- Study start
- September 16, 2025
- Record last updated
- October 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is 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).
More information can be found here: https://clinicaltrials.argenx.com/emnergize
Being studied: Empasiprubart IV; Placebo IV
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; CIDP; Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
University of Alabama at Birmingham - 1720 University Blvd
Birmingham, AL 35233
Site contact: Eroboghene Ubogu, MD · 857-350-4834 · clinicaltrials@argenx.com
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, CA 92270
Site contact: Samir Macwan, MD · 760-834-3540 · smacwan@southlandneuromuscular.com; samirmacwan@gmail.com
Colorado Springs Neurological Associates
Colorado Springs, CO 80907
Site contact: David Stevens, MD · 719-389-1159 · dstevens@csneuro.com
Medstar Health Research Institute
Washington D.C., DC 20010
Site contact: Yasir Al-Khalili, MD · 857-350-4834 · yasir.al-khalili@medstar.net
Gables Neurology
Miami, FL 33133
Site contact: Andrew Lerman, MD · 954-243-5559 · alerman@fcneurology.net
Aqualane Clinical Research
Naples, FL 34105
Site contact: Matthew Baker, MD · 650-723-6961 · Matthew@aqualaneresearch.com
Vero Beach Neurology and Research Institute
Vero Beach, FL 32960-4806
Site contact: Stuart Shafer · (888) 888-8888 · sshafer@geodysseyrsch.com
Paradigm Health System
Slidell, LA 70458
Site contact: Patrick Glynn, MD · 985-882-4500 · trickpatglynn@yahoo.com
Penn Medicine University City
Philadelphia, PA 19104-5545
Site contact: Sami Khella, MD · 215-662-8870 · sami.khella@pennmedicine.upenn.edu
Jefferson Health Honickman Center
Philadelphia, PA 19107
Site contact: Goran Rakocevic, MD · 857-350-4834 · clinicaltrials@argenx.com
University Neurology
Knoxville, TN 37920-1511
Site contact: Christopher Scheiner, MD · 865-521-6174 · cscheiner@utmck.edu
National Neuromuscular Research Institute
Austin, TX 78756
Site contact: Yessar Hussain, MD · 512-920-0140 · yessar@austinneuromuscle.com
NeuroCarePlus
Houston, TX 77094
Site contact: Nicolas Nammour, MD · 281-579-6800 · nicolas.nammour@sclamanagement.com
Study contacts (from the official record)
- Sabine Coppieters, MD · 857-350-4834 · clinicaltrials@argenx.com
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