Clinical trial • Phase III • Neurology

EMPASIPRUBART for Chronic inflammatory demyelinating polyneuropathy

Phase III trial of EMPASIPRUBART for Chronic inflammatory demyelinating polyneuropathy.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Chronic inflammatory demyelinating polyneuropathy
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Other antibody

Key dates

Initial CTIS Submission Date
07-08-2025
First CTIS Authorization Date
01-12-2025

Trial design

Randomised, open-label, human normal immunoglobulin (iv) (ivig) administered intravenously as standard optimal maintenance dosing regimen (comparator arm: ivig + empasiprubart-placebo). inclusion criterion specifies a minimum weekly ivig dose of at least 0.125 g/kg for enrolled participants. study uses double-dummy design with placebos for blinding.-controlled Phase III trial across 57 sites in Bulgaria, Greece, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Human normal immunoglobulin (IV) (IVIg) administered intravenously as standard optimal maintenance dosing regimen (comparator arm: IVIg + empasiprubart-placebo). Inclusion criterion specifies a minimum weekly IVIg dose of at least 0.125 g/kg for enrolled participants. Study uses double-dummy design with placebos for blinding.
Target Sample Size
110
Trial Duration For Participant
886

Eligibility

Recruits 110 Vulnerable populations not selected (isVulnerablePopulationSelected=false). Participants are adults; informed consent required. Study-specific ICFs provided (Main ICF; pregnancy and birth ICFs; optional genetic testing / substudy ICFs) in multiple country/language versions..

Vulnerable Population
Vulnerable populations not selected (isVulnerablePopulationSelected=false). Participants are adults; informed consent required. Study-specific ICFs provided (Main ICF; pregnancy and birth ICFs; optional genetic testing / substudy ICFs) in multiple country/language versions.

Inclusion criteria

  • {"criterion_text":"- 1. Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)\n- 2. Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP.\n- 3. Has responded to IVIg in the past 5 years.\n- 4. Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg\n- 5. Has residual disability and active disease"}

Exclusion criteria

  • {"criterion_text":"- 1. Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)\n- 2. Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes\n- 3. Use of other long-acting immunomodulatory treatment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Decrease of ≥1 point compared with baseline in aINCAT score at week 24","definition_or_measurement_approach":"Decrease ≥1 point from baseline in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) score measured at Week 24 compared with baseline."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) centile points score at week 24","definition_or_measurement_approach":"Change from baseline in I-RODS centile points at Week 24."}
  • {"endpoint_text":"- 2. Change from baseline in Medical Research Council Sum Score (MRC-SS) at week 24","definition_or_measurement_approach":"Change from baseline in MRC-SS at Week 24."}
  • {"endpoint_text":"- 3. Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24","definition_or_measurement_approach":"Change from baseline in dominant-hand grip strength measured as 3-day moving average at Week 24."}
  • {"endpoint_text":"- 4. Time to reduction of ≥1 point from baseline in aINCAT score","definition_or_measurement_approach":"Time (days) to first observed reduction ≥1 point in aINCAT compared with baseline, assessed up to Week 24."}
  • {"endpoint_text":"- 5. Change from baseline in Timed Up and Go (TUG) at week 24","definition_or_measurement_approach":"Change from baseline in TUG test result at Week 24."}
  • {"endpoint_text":"- 6. Time to increase of ≥1 point compared with baseline in aINCAT score by week 24","definition_or_measurement_approach":"Time (days) to first observed increase ≥1 point in aINCAT compared with baseline, assessed through Week 24."}
  • {"endpoint_text":"- 7. Change from baseline in grip strength (3-day moving average) of both hands over time and change from baseline in grip strength (daily average) for both hands","definition_or_measurement_approach":"Change from baseline over time in grip strength for both hands measured as 3-day moving average and daily average."}
  • {"endpoint_text":"- 8. Change from baseline in aINCAT over time","definition_or_measurement_approach":"Change from baseline in aINCAT score assessed longitudinally over study visits."}
  • {"endpoint_text":"- 9. Change from baseline in I-RODS centile points score over time","definition_or_measurement_approach":"Longitudinal change from baseline in I-RODS centile points."}
  • {"endpoint_text":"- 10. Change from baseline in MRC-SS over time","definition_or_measurement_approach":"Longitudinal change from baseline in Medical Research Council Sum Score."}
  • {"endpoint_text":"- 11. Change from baseline in TUG over time","definition_or_measurement_approach":"Longitudinal change from baseline in the Timed Up and Go test."}
  • {"endpoint_text":"- 12. Change from baseline in EQ-5D-5L, RT-FSS, SF-12 and BPI-SF over time","definition_or_measurement_approach":"Longitudinal changes from baseline in patient-reported outcome measures EQ-5D-5L, RT-FSS, SF-12 and BPI-SF."}
  • {"endpoint_text":"- 13. PGI-S and PGI-C values over time","definition_or_measurement_approach":"Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Change (PGI-C) tracked over time."}
  • {"endpoint_text":"- 14. Values for work-related and household chore activities of the HRPQ","definition_or_measurement_approach":"HRPQ-derived values for work-related and household activities."}
  • {"endpoint_text":"- 15. Percentage of scheduled hours lost in total (absenteeism + presenteeism)","definition_or_measurement_approach":"Percentage of scheduled hours lost due to absenteeism and presenteeism (work productivity metrics)."}
  • {"endpoint_text":"- 16. Incidence and prevalence of antidrug antibodies and neutralizing antibodies against empasiprubart in serum","definition_or_measurement_approach":"Incidence and prevalence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) measured in serum samples."}
  • {"endpoint_text":"- 17. Incidence and severity of adverse events, incidence of serious adverse events and clinically meaningful changes in laboratory parameters, ECG results, and vital signs","definition_or_measurement_approach":"Safety assessments including AE/SAE incidence and severity, clinical lab changes, ECGs and vital signs."}
  • {"endpoint_text":"- 18. Absolute values and percentage change from baseline in free C2 and total C2 over time","definition_or_measurement_approach":"Pharmacodynamic measures: absolute and percent change from baseline in free C2 and total C2 over time."}
  • {"endpoint_text":"- 19. Serum concentrations of empasiprubart over time","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentration-time profile of empasiprubart."}

Recruitment

Registry Or Advocacy Recruitment
True, Amsterdam UMC Stichting (listed as a patient organisation/association site) and patient-advocacy contact lists documented (Site-and-Patient-Advocacy-Contact-List).
Digital Remote Recruitment
True - digital patient brochures and digital recruitment materials (e.g. 'Patient-Brochure-Digital' documents) are listed for multiple countries to support recruitment.
Planned Sample Size
110
Recruitment Window Months
53
Consent Approach
Informed consent obtained from adult participants via Main ICF (country/language-specific versions). Additional ICFs available for pregnancy and birth, optional genetic testing/substudies, and other optional substudy consent. ICFs provided in multiple languages (examples in repository include English, Greek, Dutch, German, Portuguese, Estonian, Russian, Slovak, Slovenian, Polish, Spanish, French, Italian, Czech, Swedish, Norwegian, Hungarian, Romanian). Consent is provided by the participant (assent not applicable given adult population).

Methods

  • Patient brochures (print) distributed in clinics and hospitals (country-specific versions present).
  • Digital patient brochures / digital recruitment materials (country-specific).
  • Patient flyers and posters for display at clinical sites.
  • Doctor-to-patient letters and GP letters to inform clinicians and facilitate referrals.
  • Patient letters and patient postcards distributed to potential participants.
  • Site-and-Patient-Advocacy contact lists and recruitment arrangements documents (country-specific).

Geography

Total Number Of Sites
57
Total Number Of Participants
110

Bulgaria

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
13
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology Clinic
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com
Site Name
Alexandrovska University Hospital
Department Name
Clinic of Neurological Diseases,
Contact Person Name
Ivaylo Tarnev
Contact Person Email
itournev@emhpf.org
Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Sashka Zhelyazkova
Contact Person Email
doc_sashka@abv.bg

Greece

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
92
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Department of Neurology Clinic of the National and Kapodistrian University of Athens
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr
Site Name
University General Hospital Of Alexandroupoli
Department Name
Department of Neurology
Contact Person Name
Aikaterini Terzoudi
Contact Person Email
katerzoudi@hotmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
29
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Neurology
Contact Person Name
Ludo Van der Pol
Contact Person Email
w.l.vanderpol@umcutrecht.nl
Site Name
Amsterdam UMC Stichting
Department Name
Neurology
Contact Person Name
Filip Eftimov
Contact Person Email
f.eftimov@amsterdamumc.nl

Austria

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
46
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Neurology
Contact Person Name
Jakob Rath
Contact Person Email
jakob.rath@meduniwien.ac.at
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of Neurology
Contact Person Name
Christian Eggers

Portugal

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
53
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Neurology
Contact Person Name
Ernestina Santos
Contact Person Email
ernestina.santos@gmail.com

Estonia

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
20
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Clinic4U OÜ
Contact Person Name
Katrin Gross-Paju
Site Name
Tartu University Hospital
Contact Person Name
Liis Väli
Contact Person Email
Liis.Vali@kliinikum.ee

Slovakia

Earliest CTIS Part Ii Submission Date
11-11-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
20
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Univerzitna Nemocnica Martin
Department Name
Neurologická klinika
Contact Person Name
Monika Turčanová Koprušáková
Contact Person Email
koprusakova@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
98
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Institutul National De Neurologie Si Boli Neurovasculare Bucuresti
Department Name
Neurologie I
Contact Person Name
Florian Antonescu
Contact Person Email
dr.antonescu@yahoo.com
Site Name
Brainaxy Clinic S.R.L.
Department Name
Spitalizare de zi
Contact Person Name
Any Axelerad
Contact Person Email
docuaxi@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Sectia Clinica Neurologie I
Contact Person Name
Anca-Ioana Motataianu
Contact Person Email
motataianuanca@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
56
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Medical Center - University Of Freiburg
Department Name
Abteilung für Neurologie und Neurophysiologie – Neurozentrum
Contact Person Name
Christian Keller
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Neurologie
Contact Person Name
Frank Leypoldt
Contact Person Email
Frank.leypoldt@uksh.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Neurologie Neuroscience Clinical Research Center
Contact Person Name
Frauke Stascheit
Contact Person Email
frauke.stascheit@charite.de

Denmark

Earliest CTIS Part Ii Submission Date
19-11-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
12
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Rigshospitalet
Contact Person Name
Tina Dysgaard
Contact Person Email
tina.dysgaard@regionh.dk

Italy

Earliest CTIS Part Ii Submission Date
19-11-2025
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
14
Number Of Sites
9
Number Of Participants
16

Sites

Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Neurologia
Contact Person Name
Antonio Suppa
Contact Person Email
antonio.suppa@uniroma1.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Centro Malattie Neuromuscolari – U.O.C. Neurologia
Contact Person Name
Stefania Morino
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
UOC Clinica Neurologica
Contact Person Name
Vincenzo Angelo Donadio
Contact Person Email
vincenzo.donadio@unibo.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOC Clinica Neurologica
Contact Person Name
Girolama Alessandra Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
UOC Neurologia 3
Contact Person Name
Giuseppe Lauria Pinter
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
UO Neuroncologia
Contact Person Name
Elisa Vegezzi
Contact Person Email
elisa.vegezzi@mondino.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Malattie Neuromuscolari e Neuroimmunologia
Contact Person Name
Pietro Emiliano Doneddu
Contact Person Email
Pietro.doneddu@hunimed.eu
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Neurologia B
Contact Person Name
Matteo Tagliapietra
Site Name
Azienda Ospedaliero-Universitaria Policlinico Tor Vergata (additional listed site)
Department Name
Therapy of Inflammatory Neuropathies
Contact Person Name
Girolama Alessandra Marfia
Contact Person Email
marfia@uniroma2.it

Czechia

Earliest CTIS Part Ii Submission Date
30-09-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
63
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Neurologická klinika
Contact Person Name
Magda Horáková
Contact Person Email
horakova.magda@fnbrno.cz

France

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
29
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Neurologie
Contact Person Name
Jérôme De Seze
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de neurologie et d’explorations fonctionnelles
Contact Person Name
Pascal Cintas
Contact Person Email
cintas.p@chu-toulouse.fr
Site Name
Bicetre Hospital
Department Name
CRMR Neurologie
Contact Person Name
Andoni Echaniz-Laguna
Contact Person Email
andoni.echaniz-laguna@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de neurologie et de maladies neuromusculaires
Contact Person Name
Gwendal Le Masson
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Neurologie-Système Nerveux Périphérique et Muscle
Contact Person Name
Sabrina Sacconi
Contact Person Email
sacconi.s@chu-nice.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Centre de Référence des Maladies Neuromusculaires rares de la SLA
Contact Person Name
Shahram Attarian
Contact Person Email
shahram.attarian@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurophysiologie Clinique
Contact Person Name
Charline Benoit
Contact Person Email
charline.benoit@aphp.fr

Slovenia

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
94
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
University Medical Center Ljubljana
Department Name
Neurology
Contact Person Name
Blaž Koritnik
Contact Person Email
blaz.koritnik@kclj.si
Site Name
UNIVERZITETNI KLINICNI CENTER MARIBOR
Department Name
Neurology
Contact Person Name
Timotej Petrijan
Contact Person Email
timotej.petrijan@ukc-mb.si

Sweden

Earliest CTIS Part Ii Submission Date
29-10-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
40
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
MS-Centrum, Blå Stråket 7, 413 45 Göteborg
Contact Person Name
Lenka Nováková Nyrén
Contact Person Email
lenka.novakova@vgregion.se

Norway

Earliest CTIS Part Ii Submission Date
28-10-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
35
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Oslo University Hospital HF
Department Name
Forskning og Utvikling | Nevroklinikken,
Contact Person Name
Angelina Hatlø Maniaol
Contact Person Email
angman@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
104
Number Of Sites
10
Number Of Participants
20

Sites

Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Neurologii
Contact Person Name
Agnieszka Słowik
Contact Person Email
neurologiabk@su.krakow.pl
Site Name
Galen Clinic (Warszawa)
Contact Person Name
Urszula Chyrchel-Paszkiewicz
Contact Person Email
pgluchyrchel@gmail.com
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Contact Person Name
Artur Drużdż
Contact Person Email
artur.druzdz@cr-center.pl
Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Contact Person Name
Robert Bonek
Contact Person Email
r.bonek@ncbydgoszcz.pl
Site Name
Galen Clinic (Lublin)
Contact Person Name
Urszula Chyrchel-Paszkiewicz
Contact Person Email
pgluchyrchel@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Bydgoszcz
Contact Person Name
Łukasz Rzepiński
Contact Person Email
luk.rzepinski@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Contact Person Name
Marta Masztalewicz
Contact Person Email
marta.masztalewicz@pum.edu.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o. S.K.
Contact Person Name
Halina Bartosik-Psujek
Contact Person Email
bartosikpsujek@op.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Centralny Szpital Kliniczny, Klinika Neurologii
Contact Person Name
Anna Kostera-Pruszczyk
Site Name
Linden Sp. z o.o. sp.k.
Contact Person Name
Karolina Porębska
Contact Person Email
kspisak@poczta.fm

Spain

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
75
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Neurology
Contact Person Name
Irene Catalina Álvarez
Contact Person Email
uelanm.hgugm@salud.madrid.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Contact Person Name
Raúl Juntas Morales
Contact Person Email
raul.juntas@vallhebron.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Contact Person Name
Luis Querol
Contact Person Email
mvidalf@santpau.cat
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurology
Contact Person Name
Eva María Martínez Fernández

Hungary

Earliest CTIS Part Ii Submission Date
03-10-2025
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
122
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Clinexpert Kft.
Contact Person Name
Ferenc Fazekas
Contact Person Email
dr.f.fazekas@gmail.com
Site Name
Semmelweis University
Department Name
Genomikai Medicina és Ritka Betegségek Intézete
Contact Person Name
Mária Judit Molnár
Contact Person Email
molnarmj@gmail.com

Sponsor

Primary sponsor

Full Name
Argenx
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
IQVIA Limited
Responsibilities
Pharmacovigilance and study support
Name
PPD Global Limited / PPD Global Central Labs
Responsibilities
Central laboratory services and multiple clinical support functions (various sponsor duties listed)
Name
Celerion Switzerland AG
Responsibilities
PK, Total C2, ADA&nAb assessments
Name
WCG Clinical Inc.
Responsibilities
Training portal for investigational sites

Third parties

  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"Biostatistics","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"Patient reimbursement (France only)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"Free C2 (Complement Component 2)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"PK, Total C2, ADA&nAb","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Training portal for investigational sites","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"Multiple roles (see entry): responsibilities include central lab services and other support (codes listed in sponsor duties)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"long term storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Study-related services (duty code 3 listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG device rental","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central lab services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA/Grip Strength; other data services","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Local study support (multiple duties listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient travel reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"long term storage","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ARGX-117
Active Substance
EMPASIPRUBART
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Investigational (IMP)
Investigational Product Name
HUMAN NORMAL IMMUNOGLOBULIN (IV)
Active Substance
HUMAN NORMAL IMMUNOGLOBULIN (IV)
Modality
Other antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (commercial IVIg comparator)
Frequency
Maintenance dosing regimen (standard optimal maintenance); inclusion requires minimum weekly IVIg dose ≥0.125 g/kg
Investigational Product Name
Placebo for empasiprubart- solution for IV infusion
Modality
Other
Routes Of Administration
Intravenous (placebo for ARGX-117 infusion)
Route
Intravenous
Investigational Product Name
Placebo for IVIg - solution for IV infusion
Modality
Other
Routes Of Administration
Intravenous (placebo for IVIg infusion)
Route
Intravenous

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