Clinical trial • Phase III • Neurology|Rare Disease

EMPASIPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP)

Phase III trial of EMPASIPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP).

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
06-10-2025
First CTIS Authorization Date
10-02-2026

Trial design

Randomised, open-label, empasiprubart iv (argx-117) vs placebo iv (placebo for empasiprubart - solution for iv infusion); doses/schedules not specified in ctis record-controlled Phase III trial across 46 sites in Netherlands, Slovakia, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Empasiprubart IV (ARGX-117) vs Placebo IV (Placebo for empasiprubart - solution for IV infusion); doses/schedules not specified in CTIS record
Target Sample Size
100
Trial Duration For Participant
896

Eligibility

Recruits 100 No vulnerable populations selected; participants are adults. Informed consent is via standard adult ICFs (local language ICFs available per country)..

Vulnerable Population
No vulnerable populations selected; participants are adults. Informed consent is via standard adult ICFs (local language ICFs available per country).

Inclusion criteria

  • {"criterion_text":"- Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- Has residual disability and active disease"}
  • {"criterion_text":"- 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)."}

Exclusion criteria

  • {"criterion_text":"- Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)"}
  • {"criterion_text":"- Sensory CIDP (including sensory-predominant CIDP)"}
  • {"criterion_text":"- Polyneuropathy of other causes"}
  • {"criterion_text":"- Clinical diagnosis of systemic lupus erythematosus (SLE)"}
  • {"criterion_text":"- Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation"}

Endpoints

Primary endpoints

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

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in I-RODS centile points score - up to 24 weeks (part A)","definition_or_measurement_approach":"Change from baseline in I-RODS centile points up to 24 weeks (Part A)."}
  • {"endpoint_text":"- Change from baseline in MRC-SS at week 24","definition_or_measurement_approach":"Change from baseline in Medical Research Council sum score (MRC-SS) at Week 24."}
  • {"endpoint_text":"- 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 grip strength measured as 3-day moving average in the dominant hand at Week 24."}
  • {"endpoint_text":"- Time to reduction of ≥1 point from baseline in aINCAT score - up to 24 weeks","definition_or_measurement_approach":"Time from randomisation to first occurrence of ≥1 point reduction from baseline in aINCAT score, up to 24 weeks."}
  • {"endpoint_text":"- Time to increase of ≥1 point compared with baseline in aINCAT score up to week 24","definition_or_measurement_approach":"Time from randomisation to first occurrence of ≥1 point increase from baseline in aINCAT score, up to Week 24."}
  • {"endpoint_text":"- 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 in grip strength for both hands using 3-day moving averages over time and daily averages as specified."}
  • {"endpoint_text":"- Change from baseline in MRC-SS over time. Up to 96 weeks (Part B)","definition_or_measurement_approach":"Change from baseline in MRC-SS over time, assessed up to 96 weeks (Part B)."}
  • {"endpoint_text":"- Change from baseline in aINCAT score over time","definition_or_measurement_approach":"Change from baseline in aINCAT score over time (no additional definition provided)."}
  • {"endpoint_text":"- Change from baseline in EQ-5D-5L over time","definition_or_measurement_approach":"Change from baseline in EQ-5D-5L health-related quality of life score over time."}
  • {"endpoint_text":"- Change from baseline in RT-FSS over time","definition_or_measurement_approach":"Change from baseline in RT-FSS (fatigue scale) over time."}
  • {"endpoint_text":"- Change from baseline in BPI-SF over time","definition_or_measurement_approach":"Change from baseline in Brief Pain Inventory-Short Form (BPI-SF) over time."}
  • {"endpoint_text":"- PGI-S values over time","definition_or_measurement_approach":"Patient Global Impression of Severity (PGI-S) values collected over time."}
  • {"endpoint_text":"- PGI-C values over time","definition_or_measurement_approach":"Patient Global Impression of Change (PGI-C) values collected over time."}
  • {"endpoint_text":"- Incidence and prevalence of ADA against empasiprubart in serum","definition_or_measurement_approach":"Incidence and prevalence of anti-drug antibodies (ADA) against empasiprubart in serum (as stated; specific assay details not provided in CTIS data)."}
  • {"endpoint_text":"- Incidence and prevalence of NAb against empasiprubart in serum","definition_or_measurement_approach":"Incidence and prevalence of neutralising antibodies (NAb) against empasiprubart in serum (as stated; specific assay details not provided in CTIS data)."}
  • {"endpoint_text":"- Incidence and severity of AEs","definition_or_measurement_approach":"Incidence and severity of adverse events (AEs) as reported during the study."}
  • {"endpoint_text":"- Incidence of SAEs","definition_or_measurement_approach":"Incidence of serious adverse events (SAEs) as reported during the study."}
  • {"endpoint_text":"- Clinically meaningful changes in laboratory parameters, ECG results, and vital signs","definition_or_measurement_approach":"Assessment of clinically meaningful changes in laboratory parameters, ECGs and vital signs (no further definition provided)."}
  • {"endpoint_text":"- Absolute values and percentage change from baseline in free C2 and total C2 over time","definition_or_measurement_approach":"Absolute concentrations and percent change from baseline in free C2 and total C2 measured over time."}
  • {"endpoint_text":"- Serum concentrations of empasiprubart over time","definition_or_measurement_approach":"Measurement of serum concentrations of empasiprubart over time (PK assessments)."}
  • {"endpoint_text":"- Reduction of ≥1 point in aINCAT over time","definition_or_measurement_approach":"Occurrence over time of ≥1 point reduction in aINCAT score."}
  • {"endpoint_text":"- Increase of ≥1 point from baseline in aINCAT over time","definition_or_measurement_approach":"Occurrence over time of ≥1 point increase from baseline in aINCAT score."}
  • {"endpoint_text":"- Change from baseline in TUG at week 24","definition_or_measurement_approach":"Change from baseline in Timed Up and Go (TUG) test at Week 24."}

Recruitment

Digital Remote Recruitment
True - digital patient brochures/flyers and digital patient brochure files are listed (country-specific digital brochures), and eCOA/digital grip strength tools are referenced in sponsor third-party duties.
Planned Sample Size
100
Recruitment Window Months
22
Consent Approach
Informed consent obtained from adult participants using main ICFs provided in local languages per country (Main ICF, Pregnancy ICF, Optional Genetic Testing ICF, Optional Future Research/ Substudy ICF documents present per Member State). Sponsor public/scientific contact email ClinicalTrials@argenx.com provided for queries.

Methods

  • Printed patient materials distributed via clinical sites (patient brochures, flyers, posters) targeted at potential participants in neurology clinics; doctor-to-patient letters and GP letters for clinician-mediated recruitment; digital patient brochures/flyers (country-specific digital materials) for online distribution; recruitment informed-consent procedures and site-specific recruitment packs prepared per country (documents listed per Member State in CTIS).
  • Site-based recruitment through participating hospitals/neurology clinics (site contact details provided in CTIS).

Geography

Total Number Of Sites
46
Total Number Of Participants
86

Netherlands

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
20
Number Of Sites
1
Number Of Participants
2

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

Slovakia

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
6
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Univerzitna Nemocnica Martin
Department Name
Neurologická klinika
Contact Person Name
Monika Koprušáková
Contact Person Email
koprusakova@gmail.com
Site Name
Penta Hospitals SK a.s.
Department Name
Všeobecná Nemocnica Rimavská Sobota, Neurologické oddelenie
Contact Person Name
Erika Zacharová
Site Name
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Department Name
Neurologická ambulancia
Contact Person Name
Martin Súč
Contact Person Email
martin.suc@pentahospitals.sk

Denmark

Earliest CTIS Part Ii Submission Date
15-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
26
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Rigshospitalet
Department Name
Copenhagen Neuromuscular Center
Contact Person Name
Tina Dysgaard
Contact Person Email
tina.dysgaard@regionh.dk

Czechia

Earliest CTIS Part Ii Submission Date
20-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
21
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
19-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
28
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Neurologie
Contact Person Name
Thierry GENDRE
Contact Person Email
thierry.gendre@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Neurologie
Contact Person Name
Celine TARD
Contact Person Email
celine.tard@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris)
Department Name
Neurologie
Contact Person Name
Charline BENOIT
Contact Person Email
charline.benoit@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Neurologie/Système Nerveux Périphérique et Muscle
Contact Person Name
Sabrina SACCONI
Contact Person Email
sacconi.s@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Neurologie et de Maladies Neuromusculaires
Contact Person Name
Gwendal LE MASSON

Italy

Earliest CTIS Part Ii Submission Date
14-01-2026
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
29
Number Of Sites
12
Number Of Participants
22

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SSD Malattie Neuromuscolari e rare
Contact Person Name
Francesca Magri
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
UOC Neurofisiopatologia
Contact Person Name
Francesco Habetswallner
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Neurologia B
Contact Person Name
Matteo Tagliapietra
Site Name
Centro Clinico Nemo
Contact Person Name
Massimiliano Filosto
Contact Person Email
massimiliano.filosto@unibs.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Dipartimento Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno Infantili – DINO
Contact Person Name
Angelo Schenone
Contact Person Email
aschenone@neurologia.unige.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC (UCO) Clinica Neurologica
Contact Person Name
Paolo Manganotti
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
U.O.C. Neurologia
Contact Person Name
Antonio Suppa
Contact Person Email
antonio.suppa@uniroma1.it
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
U.O. Neuroncologia
Contact Person Name
Elisa Vegezzi
Contact Person Email
elisa.vegezzi@mondino.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC Neurologia
Contact Person Name
Giulia Ricci
Contact Person Email
giulia.ricci@med.unipi.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO Neurologia
Contact Person Name
Stefano Carlo Previtali
Contact Person Email
Previtali.stefano@hsr.it
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
Casa Sollievo Della Sofferenza
Department Name
Neurologia
Contact Person Name
Paolo Emilio Alboini

Romania

Earliest CTIS Part Ii Submission Date
15-01-2026
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
29
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Spitalul Judetean De Urgenta Deva
Department Name
Neurology
Contact Person Name
Cecilia Laura Albu
Contact Person Email
albu.cecilia@yahoo.com
Site Name
Neurocity S.R.L.
Department Name
Neurology
Contact Person Name
Dan-Andrei Mitrea
Contact Person Email
dan.mitrea@neuroaxis.ro
Site Name
Teo Health S.A.
Department Name
Neurology
Contact Person Name
Letitia Zecheru-Lapusneanu
Contact Person Email
letitialapusneanu@gmail.com
Site Name
Clubul Sanatatii S.R.L.
Department Name
Neurology
Contact Person Name
Emilian-Silviu Manescu
Contact Person Email
silviumanescu@yahoo.com

Slovenia

Earliest CTIS Part Ii Submission Date
14-01-2026
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
28
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
University Medical Center Ljubljana
Department Name
Institute of Clinical Neurophysiology
Contact Person Name
Blaz Koritnik
Contact Person Email
blaz.koritnik@kclj.si

Austria

Earliest CTIS Part Ii Submission Date
15-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
32
Number Of Sites
2
Number Of Participants
4

Sites

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

Bulgaria

Earliest CTIS Part Ii Submission Date
12-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
35
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of Neurological diseases
Contact Person Name
Mariya Dimitrova
Contact Person Email
dr.m.i.dimitrova@gmail.com
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
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Neurodegenerative and Peripheral Nerve Disorders Clinic - nervous diseases
Contact Person Name
Ivan Milanov
Contact Person Email
ubalnp@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
Medical Center Medica 2005 EOOD
Contact Person Name
Plamen Tsvetanov
Contact Person Email
tsvetanovmd@mail.bg

Estonia

Earliest CTIS Part Ii Submission Date
09-01-2026
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
35
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Clinic4U OÜ
Contact Person Name
Katrin Gross-Paju

Finland

Earliest CTIS Part Ii Submission Date
14-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
27
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Pohjois-Pohjanmaan hyvinvointialue (Oulu University Hospital - Neurology)
Department Name
Oulu University Hospital - Neurology, Clinical research unit
Contact Person Name
Hanna Ansakorpi
Contact Person Email
Hanna.ansakorpi@oulu.fi

Hungary

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
112
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Clinexpert Kft.
Contact Person Name
Ferenc FAZEKAS
Contact Person Email
dr.f.fazekas@gmail.com
Site Name
Semmelweis University
Contact Person Name
Mária Judit MOLNÁR
Contact Person Email
molnarmj@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
14-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
33
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Galen Clinic (Lublin)
Contact Person Name
Urszula Chyrchel-Paszkiewicz
Contact Person Email
pgluchyrchel@gmail.com
Site Name
Neurologia Śląska Centrum Medyczne
Contact Person Name
Marek Śmiłowski
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
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Centralny Szpital Kliniczny, Klinika Neurologii
Contact Person Name
Anna Kostera-Pruszczyk
Site Name
Galen Clinic (Warszawa)
Contact Person Name
Urszula Chyrchel-Paszkiewicz
Contact Person Email
pgluchyrchel@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
108
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
University General Hospital Of Alexandroupoli
Department Name
University Department of Neurology
Contact Person Name
Aikaterini Terzoudi
Contact Person Email
katerzoudi@hotmail.com
Site Name
Eginitio Hospital
Department Name
1st Neurology Department
Contact Person Name
Leonidas Stefanis
Contact Person Email
lstefanis@bioacademy.gr

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD Development LP / PPD Denmark Filial / PPD Global Central Labs
Responsibilities
Multiple CRO responsibilities including project management, central lab, monitoring and other listed duties (codes provided in CTIS)
Name
IQVIA Limited
Responsibilities
Pharmacovigilance
Name
Endpoint Clinical Inc.
Responsibilities
Site/CRO support (role code listed in CTIS)
Name
WCG Clinical Inc.
Responsibilities
Training portal for investigational sites
Name
SGS Belgium
Responsibilities
Biostatistics
Name
Signant Health Global LLC
Responsibilities
eCOA / digital grip strength data collection

Third parties

  • {"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":"The Doctors Laboratory Limited","duties_or_roles":"SLE (Systemic Lupus Erythematosus) Panel (EU) [inc lupus anticoag, C3 and C4 for SLE]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Training portal for investigational sites","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Sponsor duties code: 3 (role details provided in CTIS)","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":"United Kingdom","full_name":"TVS Supply Chain Solutions Limited","duties_or_roles":"Equipment and Ancillary supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Resolian Bioanalytics","duties_or_roles":"NfL (Neurofilament Light Chain)","organisation_type":"Industry"}
  • {"country":"Denmark","full_name":"PPD Denmark Filial Af PPD Scandinavia AB Sverige","duties_or_roles":"Multiple project CRO functions (codes listed in CTIS: 1,12,2,5)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA/Grip Strength","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central lab duties (code 4 in CTIS)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Multiple project functions (codes 1,11,12,13,2,4,5,8,9 listed in CTIS)","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"Biostatistics","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"R event","duties_or_roles":"Organization of Investigator meetings","organisation_type":"Health care"}
  • {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"Patient reimbursement (France only)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Universitair Medisch Centrum Utrecht","duties_or_roles":"Site-related duties (code 4 in CTIS)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"Clinical Outcomes Solutions Limited","duties_or_roles":"Patient Exit Interview","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG device rental","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Clinical Outcomes Solutions Limited (additional entry)","duties_or_roles":"Exit interviews (argenx)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Project management duties or monitoring/regulatory","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ARGX-117
Active Substance
EMPASIPRUBART
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Product record prodAuthStatus=1 (as listed in CTIS)
Investigational Product Name
Placebo for empasiprubart- solution for IV infusion
Modality
Other
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion

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