Actively Recruiting
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Led by argenx · Updated on 2026-05-08
218
Participants Needed
73
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of empasiprubart compared to intravenous immunoglobulin (IVIg) for adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This Phase 3 randomized, double-blinded, double-dummy study aims to compare these two intravenous treatments over a six-month period and further assess empasiprubart over an extended 24-month follow-up. The study is divided into two parts. In Part A, lasting 24 weeks, participants receive either empasiprubart with a placebo mimicking IVIg or IVIg with a placebo mimicking empasiprubart. After completing Part A, all participants move to Part B, which lasts 96 weeks, where everyone receives empasiprubart. This design allows comparison in the first phase and extended evaluation of empasiprubart in the second phase. Participants will undergo regular assessments throughout both parts, including measurements of muscle strength, disability scores, grip strength, and quality of life. Researchers will monitor changes in clinical scales such as the aINCAT score to evaluate improvements or declines in symptoms. Safety is also closely tracked by recording adverse events and antibody responses. The total participation time spans up to 120 weeks, combining both study parts.
CONDITIONS
Brief Title
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with CIDP based on the 2021 EAN/PNS Task Force CIDP guidelines
- Has typical CIDP or one of the following CIDP variants: motor CIDP, multifocal CIDP (Lewis-Sumner syndrome), focal CIDP, or distal CIDP
- Has responded to intravenous immunoglobulin (IVIg) treatment in the past 5 years
- Currently receiving IVIg treatment within a standard maintenance dosing regimen with a minimum weekly dose of at least 0.125 g/kg
- Has residual disability and active CIDP disease
You will not qualify if you...
- Has any known autoimmune disease or medical condition, other than CIDP, that could interfere with assessing CIDP symptoms or pose undue risk
- Meets criteria for possible or sensory CIDP based on the 2021 EAN/PNS Task Force CIDP guidelines
- Currently using other long-acting immunomodulatory treatments
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; up to 96 weeks for Part B
Participants receive intravenous infusions of either empasiprubart or IVIg, along with matching placebos, according to randomized assignment during Part A, followed by empasiprubart treatment only in Part B for those who continue.
Regular visits during treatment period for infusion and assessments
Trial Site Locations
Total: 73 locations
1
Samir Macwan, M.D., Inc.
Rancho Mirage, California, United States, 922701
Actively Recruiting
2
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
3
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Homestead Associates in Research Inc
Homestead, Florida, United States, 33033
Actively Recruiting
5
Visionary Investigators Network
Miami, Florida, United States, 33133
Actively Recruiting
6
University of South Florida
Tampa, Florida, United States, 33616
Actively Recruiting
7
Paradigm Health System
Slidell, Louisiana, United States, 70458
Actively Recruiting
8
Erlanger Health System
Columbia, Maryland, United States, 21044
Actively Recruiting
9
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
NeuroCarePlus
Houston, Texas, United States, 77094
Actively Recruiting
11
National Neuromuscular Research Institute
Irving, Texas, United States, 75063
Actively Recruiting
12
INECO Neurociencias Oroño
Rosario, Argentina, S2000DTP
Actively Recruiting
13
Universitätsklinikum AKH Wien
Vienna, Austria, 1090
Actively Recruiting
14
Fakultni nemocnice Brno
Brno, Czechia
Actively Recruiting
15
Astra Kliinik
Tallinn, Estonia, 11315
Actively Recruiting
16
Tartu University Hospital
Tartu, Estonia, 50406
Actively Recruiting
17
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33076
Actively Recruiting
18
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
19
CHU de Nice-Hôpital Pasteur
Nice, France, 6001
Actively Recruiting
20
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67200
Actively Recruiting
21
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, France, 31059
Actively Recruiting
22
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
23
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
24
University General Hospital of Alexandroupolis
Athens, Greece, 15562
Actively Recruiting
25
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, Greece, 124 62
Actively Recruiting
26
The Barzilai University Medical Center
Ashkelon, Israel, 78278
Actively Recruiting
27
Hadassah Medical Center- Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
28
The Chaim Sheba Medical Center
Tel Litwinsky, Israel, 52621
Actively Recruiting
29
AUSL di Bologna - Ospedale Bellaria
Bologna, Italy, 40139
Actively Recruiting
30
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Italy, 27100
Actively Recruiting
31
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, Italy, 00189
Actively Recruiting
32
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, Italy, 161
Actively Recruiting
33
Aomori Prefectural Central Hospital
Aomori, Japan, 030-8553
Actively Recruiting
34
Juntendo University Hospital
Bunkyō City, Japan, 113-8431
Actively Recruiting
35
Chiba University Hospital
Chūōku, Japan, 260-8677
Actively Recruiting
36
Juntendo Shizuoka University Hospital
Izunokuni, Japan, 410-2295
Actively Recruiting
37
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
38
Saga University Hospital
Saga, Japan, 849-8501
Actively Recruiting
39
General Hospital Tsuchiura Kyodo Hospital
Tsuchiura, Japan, 300-0028
Actively Recruiting
40
Yamaguchi University Hospital
Ube, Japan, 755-0067
Actively Recruiting
41
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
42
Oslo Universitetssykehus HF, Ullevål
Oslo, Norway, 450
Actively Recruiting
43
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Poland, 85-065
Actively Recruiting
44
Neurocentrum Bydgoszcz
Bydgoszcz, Poland, 85-796
Actively Recruiting
45
Centrum Medyczne Neurologia Slaska
Katowice, Poland, 40-689
Actively Recruiting
46
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688
Actively Recruiting
47
Centrum Medyczne Linden
Krakow, Poland, 30-721
Actively Recruiting
48
Galen Clinic - Lublin
Lublin, Poland, 20-064
Actively Recruiting
49
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Poznan, Poland, 61-731
Actively Recruiting
50
Centrum Medyczne Medyk
Rzeszów, Poland, 35-210
Actively Recruiting
51
Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie
Szczecin, Poland, 71-252
Actively Recruiting
52
Uniwersytecki Szpital Kliniczny Nr 1
Szczecin, Poland, 71-252
Actively Recruiting
53
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland, 02-097
Actively Recruiting
54
ULS de Santo António, EPE - Hospital de Santo António
Porto, Portugal, 4050-342
Actively Recruiting
55
Institutul National de Neurologie si Boli Neurovasculare Bucuresti
Bucharest, Romania, 41914
Actively Recruiting
56
Brainaxy Clinic SRL
Constanța, Romania, 900348
Actively Recruiting
57
Targu-Mures Emergency Clinical County Hospital
Târgu Mureş, Romania, 540136
Actively Recruiting
58
University Clinical Center of Serbia - Dr Subotica 6
Belgrade, Serbia, 11000
Actively Recruiting
59
University Clinical Center Nis
Niš, Serbia, 18 000
Actively Recruiting
60
National Neuroscience Institute
Singapore, Singapore, 308433
Actively Recruiting
61
Univerzitna nemocnica MARTIN
Martin, Slovakia, 036 59
Actively Recruiting
62
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
63
University Clinical Centre Maribor
Maribor, Slovenia, 2000
Actively Recruiting
64
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
65
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
66
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
67
Konkuk University Medical Center
Seoul, South Korea, 05030
Actively Recruiting
68
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
69
Hospital Universitario Vall d'Hebron
Sant Andreu de la Barca, Spain, 08740
Actively Recruiting
70
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
71
Sahlgrenska University Hospital
Gothenburg, Sweden, 41346
Actively Recruiting
72
Hôpitaux Universitaires de Genève (HUG)
Geneva, Switzerland, 1205
Actively Recruiting
73
Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
Samsun, Turkey (Türkiye), 55200
Actively 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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