NCT07091630RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- 16 Sept 2025
- Primary completion date
- 7 Oct 2027
- Lead sponsor
- argenx
- NCT number
- NCT07091630
- EU CT number
- 2025-520805-10-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 160
- From 16 Sept 2025 to the primary completion date, 7 Oct 2027
- 98 sites in 27 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (98)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Privado Kremer Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Instituto Médico de la Fundación Estudios Clínicos Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| INECO Neurociencias Oroño Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Kepler Universitaetsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Alexandrovska University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Medica 2005 EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| L2 Ip Instituto de Pesquisas Clinicas Ltda ME Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| Hospital de Clinicas de Porto Alegre HCPA PPDS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - UPS - PPDS Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| Unidade de Pesquisa Clinica e Inovacao da Estacio Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Escola Bahiana de Medicina e Saude Publica Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| PSEG Centro de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Peking University First Hospital - Changqiao Campus Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Fujian Medical University Union Hospital - Yushan Campus Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The People's Hospital of Baiyun District Guangzhou Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Xi'an Gaoxin Hospital Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico Coordinator of this site? Confirm its status | Medellín | Colombia | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Clinic4U OÜ Coordinator of this site? Confirm its status | Tallinn | Estonia | Recruiting |
| Pohjois-Pohjanmaan hyvinvointialue Coordinator of this site? Confirm its status | Oulu | Finland | Not yet recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Kent and Canterbury Hospital Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Recruiting |
| The National Hospital for Neurology and Neurosurgery - PPDS Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Queen'S Medical Centre Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Salford Royal Hospital Coordinator of this site? Confirm its status | Salford | United Kingdom | Recruiting |
| High Technology Hospital Medcenter LTD Coordinator of this site? Confirm its status | Batumi | Georgia | Recruiting |
| First Medical Clinic LLC Coordinator of this site? Confirm its status | Batumi | Georgia | Recruiting |
| Jo Ann Medical Center Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Aleksandre Aladashvili Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Curatio, Jsc Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Geo Hospitals Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Petre Sarajishvili Institute of Neurology Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| LTD "New Hospitals" Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| University General Hospital of Alexandroupoli Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Recruiting |
| Eginitio Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| Hillel Yaffe Medical Center Coordinator of this site? Confirm its status | Hadera | Israel | Recruiting |
| The Chaim Sheba Medical Center - PPDS Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Centro Clinico Nemo Coordinator of this site? Confirm its status | Gussago | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Institute of Science Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| Seirei Hamamatsu Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Recruiting |
| Southern TOHOKU Medical Clinic Coordinator of this site? Confirm its status | Kōriyama | Japan | Recruiting |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Institutul de Neurologie si Neurochirurgie Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Neurologia Śląska Centrum Medyczne Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Galen Clinic Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Galen Clinic Coordinator of this site? Confirm its status | Warszawa | Poland | Recruiting |
| Centrul Medical Unirea S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Recruiting |
| Neurocity S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Clubul Sanatatii S.R.L. Coordinator of this site? Confirm its status | Campulung | Romania | Recruiting |
| Spitalul Judetean de Urgenta Deva Coordinator of this site? Confirm its status | Deva | Romania | Recruiting |
| National Neuroscience Institute Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| University Medical Center Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| Univerzitna nemocnica Martin Coordinator of this site? Confirm its status | Martin | Slovakia | Recruiting |
| Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s. Coordinator of this site? Confirm its status | Michalovce | Slovakia | Recruiting |
| Penta hospitals SK, a.s. Coordinator of this site? Confirm its status | Rimavská Sobota | Slovakia | Recruiting |
| National Neuromuscular Research Institute Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| University of Alabama at Birmingham - 1720 University Blvd Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Colorado Springs Neurological Associates Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| NeuroCarePlus Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University Neurology Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Gables Neurology Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Aqualane Clinical Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Jefferson Health Honickman Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Penn Medicine University City Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Samir Macwan, M.D., Inc. (S corporation) Coordinator of this site? Confirm its status | Rancho Mirage | United States | Recruiting |
| Paradigm Health System Coordinator of this site? Confirm its status | Slidell | United States | Recruiting |
| Vero Beach Neurology and Research Institute Coordinator of this site? Confirm its status | Vero Beach | United States | Recruiting |
| Medstar Health Research Institute Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.