A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
In brief
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 facts
- Study ID
- NCT07091630
- Run by
- argenx
- People needed
- 160
- Starts
- 2025-09-16
- Expected to finish
- 2031-01-23
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Fakultni nemocnice Brno — Brno, Czechia (enrolling)
- CHU de Nice-Hôpital Pasteur — Nice, France (enrolling)
- Samir Macwan, M.D., Inc. (S corporation) — Rancho Mirage, California, United States (enrolling)
- Xi'an Gaoxin Hospital — Xi'an, China (enrolling)
- Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States (enrolling)
- Astra Kliinik — Tallinn, Estonia (enrolling)
- Medstar Health Research Institute — Washington D.C., District of Columbia, United States (enrolling)
- National Neuromuscular Research Institute — Austin, Texas, United States (enrolling)
- NeuroCarePlus — Houston, Texas, United States (enrolling)
- Gables Neurology — Miami, Florida, United States (enrolling)
- Instituto Médico de la Fundación Estudios Clínicos — Rosario, Argentina (enrolling)
- Aqualane Clinical Research — Naples, Florida, United States (enrolling)
- Paradigm Health System — Slidell, Louisiana, United States (enrolling)
- Universitätsklinikum AKH Wien — Vienna, Austria (enrolling)
- PSEG Centro de Pesquisa Clinica — São Paulo, Brazil (enrolling)
- Penn Medicine University City — Philadelphia, Pennsylvania, United States (enrolling)
- University Multiprofile Hospital for Active Treatment — Pleven, Bulgaria (enrolling)
- Medical Center Medika 2005 - Branch Sofia — Sofia, Bulgaria (enrolling)
- University Multiprofile Hospital for Active Treatment Aleksandrovska EAD — Sofia, Bulgaria (enrolling)
- University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD — Sofia, Bulgaria (enrolling)
- Instituto Privado Kremer — Córdoba, Argentina (enrolling)
- Peking University First Hospital - Changqiao Campus — Beijing, China (enrolling)
- Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, China (enrolling)
- Nanfang Hospital Southern Medical University — Guangzhou, China (enrolling)
- High Technology Hospital MedCenter Ltd — Batumi, Georgia (enrolling)
Full record on ClinicalTrials.gov
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