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
- Contact Person Email
- erika.zacharova@pentahospitals.sk
- 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
- Contact Person Email
- gwendal.le-masson@chu-bordeaux.fr
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
- Contact Person Email
- Francesca.magri@policlinico.mi.it
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- UOC Neurofisiopatologia
- Contact Person Name
- Francesco Habetswallner
- Contact Person Email
- Francesco.habetswallner@aocardarelli.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Neurologia B
- Contact Person Name
- Matteo Tagliapietra
- Contact Person Email
- Matteo.tagliapietra@aovr.veneto.it
- 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
- Contact Person Email
- paolo.manganotti@asugi.sanita.fvg.it
- 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
- Contact Person Email
- paoloemilio.alboini84@gmail.com
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
- Contact Person Email
- Christian.Eggers@kepleruniklinikum.at
- 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
- Contact Person Email
- katrin.gross-paju@astrakliinik.ee
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
- Contact Person Email
- marek.smilowski@neurologiaslaska.pl
- 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
- Contact Person Email
- anna.kostera-pruszczyk@wum.edu.pl
- 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
Related trials
Other published trials that may interest you.
- IMEROPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- RITUXIMAB for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- RILIPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- NIPOCALIMAB for Chronic inflammatory demyelinating polyneuropathy
- ROZANOLIXIZUMAB for Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD)