Actively Recruiting
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Led by argenx · Updated on 2026-05-28
160
Participants Needed
56
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the effectiveness and safety of empasiprubart in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), including typical and certain variant forms of the condition. Participants must have active disease with some residual disability and may be treatment-naive or currently receiving CIDP treatments. The study is a Phase 3, randomized, double-blinded, placebo-controlled trial sponsored by argenx. During part A, participants are randomly assigned to receive either empasiprubart or a placebo via intravenous infusion for 24 weeks (6 months). In part B, all participants receive empasiprubart for 96 weeks (24 months). Those initially receiving empasiprubart will receive a placebo once in part B to maintain the study's blind. The study evaluates various measures of disability, strength, and quality of life over these periods. Participants will have their disability measured using the adjusted INCAT score at 24 weeks as the primary outcome. Additional assessments include muscle strength, grip strength, walking tests, and patient-reported outcomes. Safety is monitored through adverse event tracking and blood tests for antibodies against empasiprubart. The total participation spans up to 120 weeks, including both parts A and B, with regular visits for treatment and evaluations.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of CIDP according to EAN/PNS Task Force CIDP guidelines, second revision (2021)
- Includes typical CIDP or variants such as motor CIDP, multifocal CIDP (Lewis-Sumner syndrome), focal CIDP, or distal CIDP
- Presence of residual disability and active disease
- Participants may be treatment-naive or currently receiving CIDP treatment (corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
- Participants currently on CIDP treatment must discontinue their prior treatment before starting the study drug and be willing to switch to the investigational medication
You will not qualify if you...
- Diagnosis of possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- Sensory CIDP or sensory-predominant CIDP
- Polyneuropathy caused by other conditions
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Use of other long-acting immunomodulatory treatments
- Prior treatment with total lymphoid irradiation or bone marrow transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks for Part A, followed by up to 96 weeks for Part B
Participants receive intravenous infusions of empasiprubart or placebo during Part A and may receive empasiprubart during Part B. This phase involves active treatment with study medication.
Regular visits during Part A and Part B for infusions and assessments
Duration - Up to 96 weeks during Part B
Participants are monitored for safety and efficacy outcomes after completing treatment phases.
Ongoing visits for assessments during Part B
Trial Site Locations
Total: 56 locations
1
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, United States, 92270
Actively Recruiting
2
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
3
Medstar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Gables Neurology
Miami, Florida, United States, 33133
Actively Recruiting
5
Aqualane Clinical Research
Naples, Florida, United States, 34105
Actively Recruiting
6
Paradigm Health System
Slidell, Louisiana, United States, 70458
Actively Recruiting
7
Penn Medicine University City
Philadelphia, Pennsylvania, United States, 19104-5545
Actively Recruiting
8
National Neuromuscular Research Institute
Austin, Texas, United States, 78756
Actively Recruiting
9
NeuroCarePlus
Houston, Texas, United States, 77094
Actively Recruiting
10
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Upper Austria, Austria, 4021
Active, Not Recruiting
11
Universitätsklinikum AKH Wien
Vienna, Austria, 1090
Actively Recruiting
12
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
Sofia, Sofia, Bulgaria, 1113
Active, Not Recruiting
13
University Multiprofile Hospital for Active Treatment
Pleven, Bulgaria, 5803
Actively Recruiting
14
Medical Center Medika 2005 - Branch Sofia
Sofia, Bulgaria, 1164
Actively Recruiting
15
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, Bulgaria, 1431
Actively Recruiting
16
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, Bulgaria, 1606
Actively Recruiting
17
Fujian Medical University Union Hospital - Yushan Campus
Fuzhou, Fujian, China, 350108
Active, Not Recruiting
18
Peking University First Hospital - Changqiao Campus
Beijing, China, 100034
Actively Recruiting
19
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, China, 510120
Actively Recruiting
20
Nanfang Hospital Southern Medical University
Guangzhou, China, 510515
Actively Recruiting
21
Xi'an Gaoxin Hospital
Xi'an, China, 710075
Actively Recruiting
22
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Actively Recruiting
23
Rigshospitalet
Copenhagen, Denmark, 2100
Active, Not Recruiting
24
Astra Kliinik
Tallinn, Estonia, 11315
Actively Recruiting
25
CHU de Bordeaux - Hôpital
Bourdeaux, France
Not Yet Recruiting
26
High Technology Hospital MedCenter Ltd
Batumi, Georgia, 6000
Actively Recruiting
27
First Medical Clinic LLC
Batumi, Georgia
Actively Recruiting
28
Petre Sarajishvili Institute of Neurology
Tbilisi, Georgia, 0112
Actively Recruiting
29
Aleksandre Aladashvili Clinic
Tbilisi, Georgia, 102
Actively Recruiting
30
Curatio JSC
Tbilisi, Georgia, 114
Actively Recruiting
31
LTD New Hospitals
Tbilisi, Georgia, 114
Actively Recruiting
32
Geo Hospitals
Tbilisi, Georgia, 144
Actively Recruiting
33
Jo Ann Medical Center
Tbilisi, Georgia, 159
Actively Recruiting
34
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece, 68100
Active, Not Recruiting
35
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
Gussago, Brescia, Italy, 25064
Active, Not Recruiting
36
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
Trieste, Friuli-VeneziaGiulia, Italy, 34149
Active, Not Recruiting
37
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy, 40139
Actively Recruiting
38
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Italy, 27100
Actively Recruiting
39
Institute of Science Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan, 113-8519
Active, Not Recruiting
40
Seirei Hamamatsu Hospital
Hiroshima, Japan, 430-8558
Actively Recruiting
41
Southern TOHOKU Medical Clinic
Kōriyama, Japan, 963-8052
Actively Recruiting
42
Saga University Hospital
Saga, Japan, 849-0937
Actively Recruiting
43
Institutul de Neurologie si Neurochirurgie
Chisinau, Moldova, 2028
Active, Not Recruiting
44
Centrum Medyczne Neurologia Slaska
Katowice, Poland, 40-689
Actively Recruiting
45
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688
Actively Recruiting
46
Galen Clinic - Warszawa
Warsaw, Poland
Active, Not Recruiting
47
S.C. Neurocity S.R.L
Bucharest, Romania
Actively Recruiting
48
SC Clubul Sanatatii SRL
Campulung Muscel, Romania, 115100
Actively Recruiting
49
Spitalul Judetean de Urgenta Deva
Deva, Romania, 330084
Actively Recruiting
50
National Neuroscience Institute
Singapore, Singapore
Active, Not Recruiting
51
Univerzitna nemocnica MARTIN
Martin, Slovakia, 036 59
Actively Recruiting
52
Nemocnica s poliklinikou S. Kukuru a.s. - Pentahospitals
Michalovce, Slovakia, 071 01
Actively Recruiting
53
Penta Hospitals SK, a.s. - Rimavská Sobota
Rimavská Sobota, Slovakia, 979 01
Actively Recruiting
54
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
55
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
56
The National Hospital for Neurology and Neurosurgery - PPDS
London, United Kingdom, WC1N3BG
Active, Not Recruiting
Research Team
S
Sabine Coppieters, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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