Clinical trial • Phase III • Immunology|Rare Disease
EFGARTIGIMOD ALFA for Ocular myasthenia gravis
Phase III trial of EFGARTIGIMOD ALFA for Ocular myasthenia gravis.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- Ocular myasthenia gravis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-10-2024
- First CTIS Authorization Date
- 04-03-2025
Trial design
Randomised, open-label, arms: efgartigimod ph20 sc (vyvgart 1 000 mg solution for injection in pre-filled syringe) versus placebo ph20 sc. dose and schedule not specified in the ctis part i/ii entries.-controlled Phase III trial in Finland, Germany, Portugal and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arms: efgartigimod PH20 SC (Vyvgart 1 000 mg solution for injection in pre-filled syringe) versus Placebo PH20 SC. Dose and schedule not specified in the CTIS Part I/II entries.
- Target Sample Size
- 98
- Trial Duration For Participant
- 119
Eligibility
Recruits 98 No vulnerable populations selected. Participants must be at least 18 years of age and meet the local legal age for consent. Country-specific caregiver informed consent forms and pregnancy/birth information/ICF documents are provided (multiple country-specific caregiver and pregnancy ICFs are listed in the trial documents)..
- Vulnerable Population
- No vulnerable populations selected. Participants must be at least 18 years of age and meet the local legal age for consent. Country-specific caregiver informed consent forms and pregnancy/birth information/ICF documents are provided (multiple country-specific caregiver and pregnancy ICFs are listed in the trial documents).
Inclusion criteria
- {"criterion_text":"- 1. Is at least 18 years of age and the local legal age of consent for clinical studies\n- 2. Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy\n- 3. Is MGFA Class I (any ocular muscle weakness)\n- 4. Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2"}
Exclusion criteria
- {"criterion_text":"- 1. Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia\n- 2. Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk"}
Endpoints
Primary endpoints
- {"endpoint_text":"- MGII (PRO) ocular score change from baseline to day 29 in part A","definition_or_measurement_approach":"Change from baseline to Day 29 in the MGII (patient-reported outcome) ocular score in Part A"}
Secondary endpoints
- {"endpoint_text":"- •\tMGII (PRO+PE) ocular score change from baseline to day 29 in part A\n- •\tMG-ADL ocular domain score change from baseline to day 29 in part A\n- •\tMGII total score change from baseline to day 29 in part A\n- •\tMGII (PE) ocular score change from baseline to day 29 in part A\n- •\tMG-ADL total score change from baseline to day 29 in part A\n- •\tMGII ocular scores (PRO, PRO+PE, and PE), generalized score, and total score; actual values and changes from baseline in part A and part A+B\n- •\tIncidence and severity of AEs and SAEs in part A and part A+B\n- •\tClinically relevant changes in laboratory parameters, vital signs, and ECGs in part A and part A+B\n- •\tMG-QoL15r total score actual values and changes from baseline in part A and part A+B\n- •\tNEI VFQ-25 score actual values and changes from baseline in part A and part A+B\n- •\tActual values and percent changes from baseline in total IgG levels over time in part A and part A+B\n- Actual values and percent change from baseline in AChR-Ab levels in AChR-Ab seropositive participants over time in part A and part A+B\n- •\tIncidence and prevalence of Anti-Drug Antibodies and Neutralizing Antibodies against efgartigimod in part A and part A+B\n- •\tIncidence and prevalence of antibodies and Neutralizing Antibodies against rHuPH20 in part A and part A+B","definition_or_measurement_approach":"Endpoints are largely change-from-baseline measures (commonly baseline to Day 29 in Part A) for clinical scales (MGII, MG-ADL), patient-reported outcomes (MG-QoL15r, NEI VFQ-25), laboratory measures (total IgG, AChR-Ab), and safety outcomes (incidence/severity of AEs/SAEs); immunogenicity endpoints measure incidence/prevalence of anti-drug and neutralizing antibodies against efgartigimod and rHuPH20 over time."}
Recruitment
- Registry Or Advocacy Recruitment
- True, site-patient-advocacy contact lists are provided (a "Site-Patient-advocacy_Contact-List-for-ICF" document is listed for Austria); specific advocacy organisation names are not specified in the CTIS documents list.
- Planned Sample Size
- 98
- Recruitment Window Months
- 38
- Consent Approach
- Adult participants (≥18 years) provide written informed consent. Country-specific Main ICFs and caregiver ICFs are provided (documents list Main ICF and Caregiver ICF translations for many Member States). ICFs and related materials are available in multiple languages corresponding to the countries listed (e.g., English, German, Dutch, French, Spanish, Portuguese, Polish, Greek, Swedish, Italian, Czech). Optional/secondary ICFs (e.g., pregnancy/follow-up, optional PK, optional future research, travel reimbursement) are provided as separate documents.
Methods
- Doctor-to-patient letters (country-specific doctor-to-patient letter documents listed for multiple Member States)
- Patient recruitment brochures/flyers/posters/site flyers (multilingual materials for sites and public listed under recruitment arrangements for multiple countries)
- Site-based recruitment through participating neurology/ophthalmology clinics and hospitals (site contact lists and site flyers provided)
- Vendor-managed recruitment support (PPD/PPD Development indicated duties include vendor management and patient recruitment)
- Patient travel and reimbursement support (Unisphere Travel / patient travel and reimbursement duties listed)
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 169
Finland
- Earliest CTIS Part Ii Submission Date
- 04-02-2025
- Latest Decision Or Authorization Date
- 17-03-2025
- Processing Time Days
- 41
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Turku University Hospital
- Department Name
- TE5, Neurokeskus
- Principal Investigator Name
- Manu Jokela
- Principal Investigator Email
- manu.jokela@varha.fi
- Contact Person Name
- Manu Jokela
- Contact Person Email
- manu.jokela@varha.fi
Germany
- Earliest CTIS Part Ii Submission Date
- 26-02-2025
- Latest Decision Or Authorization Date
- 04-03-2025
- Processing Time Days
- 6
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Neuroscience Clinical Research Center
- Principal Investigator Name
- Andreas Meisel
- Principal Investigator Email
- andreas.meisel@charite.de
- Contact Person Name
- Andreas Meisel
- Contact Person Email
- andreas.meisel@charite.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik fuer Neurologie
- Principal Investigator Name
- Jana Zschuentzsch
- Principal Investigator Email
- j.zschuentzsch@med.uni-goettingen.de
- Contact Person Name
- Jana Zschuentzsch
- Contact Person Email
- j.zschuentzsch@med.uni-goettingen.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 23-01-2025
- Latest Decision Or Authorization Date
- 05-03-2025
- Processing Time Days
- 41
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Neurology Department
- Principal Investigator Name
- Mamede de Carvalho
- Principal Investigator Email
- mamedealves@medicina.ulisboa.pt
- Contact Person Name
- Mamede de Carvalho
- Contact Person Email
- mamedealves@medicina.ulisboa.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Neurology Department
- Principal Investigator Name
- Ernestina Santos
- Principal Investigator Email
- ernestina.santos@gmail.com
- Contact Person Name
- Ernestina Santos
- Contact Person Email
- ernestina.santos@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-02-2025
- Latest Decision Or Authorization Date
- 04-03-2025
- Processing Time Days
- 6
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Neurology
- Principal Investigator Name
- Margaux Poleur
- Principal Investigator Email
- margaux.poleur@citadelle.be
- Contact Person Name
- Margaux Poleur
- Contact Person Email
- margaux.poleur@citadelle.be
- Site Name
- UZ Leuven
- Department Name
- Neurology
- Principal Investigator Name
- Kristl Claeys
- Principal Investigator Email
- kristl.claeys@uzleuven.be
- Contact Person Name
- Kristl Claeys
- Contact Person Email
- kristl.claeys@uzleuven.be
Cyprus
- Earliest CTIS Part Ii Submission Date
- 26-02-2025
- Latest Decision Or Authorization Date
- 06-03-2025
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- The Cyprus Foundation For Muscular Dystrophy Research
- Department Name
- Neuroscience Department, Neuromuscular Disorders Center,
- Principal Investigator Name
- Kleopas Kleopa
- Principal Investigator Email
- kleopa@cing.ac.cy
- Contact Person Name
- Kleopas Kleopa
- Contact Person Email
- kleopa@cing.ac.cy
Austria
- Earliest CTIS Part Ii Submission Date
- 27-02-2025
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Neurology
- Principal Investigator Name
- Fritz Zimprich
- Principal Investigator Email
- friedrich.zimprich@meduniwien.ac.at
- Contact Person Name
- Fritz Zimprich
- Contact Person Email
- friedrich.zimprich@meduniwien.ac.at
Sweden
- Earliest CTIS Part Ii Submission Date
- 31-01-2025
- Latest Decision Or Authorization Date
- 14-03-2025
- Processing Time Days
- 42
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Neurosjukvården, Blå Stråket 7, 413 45 Göteborg
- Principal Investigator Name
- Lenka Nováková Nyrén
- Principal Investigator Email
- lenka.novakova@vgregion.se
- Contact Person Name
- Lenka Nováková Nyrén
- Contact Person Email
- lenka.novakova@vgregion.se
Denmark
- Earliest CTIS Part Ii Submission Date
- 05-02-2025
- Latest Decision Or Authorization Date
- 18-03-2025
- Processing Time Days
- 41
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Aarhus University Hospital
- Department Name
- Department of Neurology
- Principal Investigator Name
- Henning Andersen
- Principal Investigator Email
- hennande@rm.dk
- Contact Person Name
- Henning Andersen
- Contact Person Email
- hennande@rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Copenhagen Neuromuscular Center
- Principal Investigator Name
- Nicolai Rasmus Preisler
- Principal Investigator Email
- nicolai.rasmus.preisler@regionh.dk
- Contact Person Name
- Nicolai Rasmus Preisler
- Contact Person Email
- nicolai.rasmus.preisler@regionh.dk
Netherlands
- Earliest CTIS Part Ii Submission Date
- 27-02-2025
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Neurology
- Principal Investigator Name
- Jan Verschuuren
- Principal Investigator Email
- Myasthenie@Lumc.nl
- Contact Person Name
- Jan Verschuuren
- Contact Person Email
- Myasthenie@Lumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 06-12-2024
- Latest Decision Or Authorization Date
- 17-03-2025
- Processing Time Days
- 101
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- UOC Clinica Neurologica
- Principal Investigator Name
- Maria Pia Giannoccaro
- Principal Investigator Email
- mariapia.giannoccaro@ausl.bologna.it
- Contact Person Name
- Maria Pia Giannoccaro
- Contact Person Email
- mariapia.giannoccaro@ausl.bologna.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- UOC Neurology
- Principal Investigator Name
- Stefania Morino
- Principal Investigator Email
- stefania.morino@ospedalesantandrea.it
- Contact Person Name
- Stefania Morino
- Contact Person Email
- stefania.morino@ospedalesantandrea.it
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- U.O.C. Neurofisiopatologia
- Principal Investigator Name
- Francesco Habetswallner
- Principal Investigator Email
- francesco.habetswallner@aocardarelli.it
- Contact Person Name
- Francesco Habetswallner
- Contact Person Email
- francesco.habetswallner@aocardarelli.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- SC Neurology
- Principal Investigator Name
- Manlio Sgarzi
- Principal Investigator Email
- msgarzi@asst-pg23.it
- Contact Person Name
- Manlio Sgarzi
- Contact Person Email
- msgarzi@asst-pg23.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- UOC Neurology IV- Neuroimmunology and Neuromuscular Diseases
- Principal Investigator Name
- Carlo Giuseppe Antozzi
- Principal Investigator Email
- carlo.antozzi@istituto-besta.it
- Contact Person Name
- Carlo Giuseppe Antozzi
- Contact Person Email
- carlo.antozzi@istituto-besta.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UOC Neurology
- Principal Investigator Name
- Stefano Carlo Previtali
- Principal Investigator Email
- previtali.stefano@hsr.it
- Contact Person Name
- Stefano Carlo Previtali
- Contact Person Email
- previtali.stefano@hsr.it
Spain
- Earliest CTIS Part Ii Submission Date
- 25-02-2025
- Latest Decision Or Authorization Date
- 04-03-2025
- Processing Time Days
- 7
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Universitario Donostia
- Department Name
- Neurology
- Principal Investigator Name
- Adolfo Jose Lopez de Munain Arregui
- Principal Investigator Email
- Adolfojose.lopezdemunainarregui@osakidetza.eus
- Contact Person Name
- Adolfo Jose Lopez de Munain Arregui
- Contact Person Email
- Adolfojose.lopezdemunainarregui@osakidetza.eus
- Site Name
- Hospital Del Mar
- Department Name
- Neurology
- Principal Investigator Name
- Miguel Angel Rubio Perez
- Principal Investigator Email
- Marubio@psmar.cat
- Contact Person Name
- Miguel Angel Rubio Perez
- Contact Person Email
- Marubio@psmar.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Neurology
- Principal Investigator Name
- Ana Isabel Pareja Martinez
- Principal Investigator Email
- pareja_anamar@gva.es
- Contact Person Name
- Ana Isabel Pareja Martinez
- Contact Person Email
- pareja_anamar@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Raul Juntas Morales
- Principal Investigator Email
- raul.juntas@vallhebron.cat
- Contact Person Name
- Raul Juntas Morales
- Contact Person Email
- raul.juntas@vallhebron.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Neurology
- Principal Investigator Name
- Rodrigo Álvarez Velasco
- Principal Investigator Email
- rodrigo.alvarez@salud.madrid.org
- Contact Person Name
- Rodrigo Álvarez Velasco
- Contact Person Email
- rodrigo.alvarez@salud.madrid.org
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Neurology
- Principal Investigator Name
- Lucia Galan Davila
- Principal Investigator Email
- lgalan@salud.madrid.org
- Contact Person Name
- Lucia Galan Davila
- Contact Person Email
- lgalan@salud.madrid.org
Czechia
- Earliest CTIS Part Ii Submission Date
- 25-02-2025
- Latest Decision Or Authorization Date
- 05-03-2025
- Processing Time Days
- 8
- Number Of Sites
- 2
- Number Of Participants
- 19
Sites
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Neurologická klinika
- Principal Investigator Name
- Stanislav Voháňka
- Principal Investigator Email
- vohanka.stanisla@fnbrno.cz
- Contact Person Name
- Stanislav Voháňka
- Contact Person Email
- vohanka.stanisla@fnbrno.cz
- Site Name
- Nemocnice Pardubickeho kraje a.s.
- Department Name
- Neurologie
- Principal Investigator Name
- Edvard Ehler
- Principal Investigator Email
- edvard.ehler@nempk.cz
- Contact Person Name
- Edvard Ehler
- Contact Person Email
- edvard.ehler@nempk.cz
Greece
- Earliest CTIS Part Ii Submission Date
- 19-11-2024
- Latest Decision Or Authorization Date
- 06-03-2025
- Processing Time Days
- 107
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- General University Hospital Of Patras
- Department Name
- Neurology Clinic
- Principal Investigator Name
- Elisabeth Chroni
- Principal Investigator Email
- echroni@yahoo.com
- Contact Person Name
- Elisabeth Chroni
- Contact Person Email
- echroni@yahoo.com
- Site Name
- Eginitio Hospital
- Department Name
- 1st Neurology Department
- Principal Investigator Name
- Vasiliki Zouvelou
- Principal Investigator Email
- vzouvelu@med.uoa.gr
- Contact Person Name
- Vasiliki Zouvelou
- Contact Person Email
- vzouvelu@med.uoa.gr
France
- Earliest CTIS Part Ii Submission Date
- 21-02-2025
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 17
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Fondation A De Rothschild
- Department Name
- Service de Neurologie
- Principal Investigator Name
- Antoine GUEGUEN
- Principal Investigator Email
- agueguen@for.paris
- Contact Person Name
- Antoine GUEGUEN
- Contact Person Email
- agueguen@for.paris
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Service Neurologie
- Principal Investigator Name
- Christelle BLANC-LABARRE
- Principal Investigator Email
- christelle.blanc@chu-dijon.fr
- Contact Person Name
- Christelle BLANC-LABARRE
- Contact Person Email
- christelle.blanc@chu-dijon.fr
- Site Name
- Quinze-Vingts National Ophthalmology Hospital
- Department Name
- Service de Médecine Interne
- Principal Investigator Name
- Jennifer ABOAB
- Principal Investigator Email
- jaboab@15-20.fr
- Contact Person Name
- Jennifer ABOAB
- Contact Person Email
- jaboab@15-20.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service Neurologie
- Principal Investigator Name
- Saskia BRESCH
- Principal Investigator Email
- bresch.s@chu-nice.fr
- Contact Person Name
- Saskia BRESCH
- Contact Person Email
- bresch.s@chu-nice.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 26-02-2025
- Latest Decision Or Authorization Date
- 09-03-2025
- Processing Time Days
- 11
- Number Of Sites
- 5
- Number Of Participants
- 32
Sites
- Site Name
- Clinirem Sp. z o.o.
- Principal Investigator Name
- Urszula Chyrchel-Paszkiewicz
- Principal Investigator Email
- pgluchyrchel@gmail.com
- 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
- Principal Investigator Name
- Łukasz Rzepiński
- Principal Investigator Email
- luk.rzepinski@gmail.com
- Contact Person Name
- Łukasz Rzepiński
- Contact Person Email
- luk.rzepinski@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Zespół Poradni Specjalistycznych - Botaniczna 3, Poradnia Neurologiczna
- Principal Investigator Name
- Agnieszka Słowik
- Principal Investigator Email
- neurologiabk@su.krakow.pl
- Contact Person Name
- Agnieszka Słowik
- Contact Person Email
- neurologiabk@su.krakow.pl
- Site Name
- Neurologia Śląska Centrum Medyczne
- Principal Investigator Name
- Marek Śmiłowski
- Principal Investigator Email
- marek.smilowski@neurologiaslaska.pl
- Contact Person Name
- Marek Śmiłowski
- Contact Person Email
- marek.smilowski@neurologiaslaska.pl
- Site Name
- Krakowska Akademia Neurologii Sp. z o.o.
- Principal Investigator Name
- Andrzej Szczudlik
- Principal Investigator Email
- Andrzej.Szczudlik@neurologia.org.pl
- Contact Person Name
- Andrzej Szczudlik
- Contact Person Email
- Andrzej.Szczudlik@neurologia.org.pl
Sponsor
Primary sponsor
- Full Name
- Argenx
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- PPD Development LP / PPD International / PPD Global Ltd. / PPD Denmark Filial Af PPD Scandinavia AB Sverige
- Responsibilities
- Vendor management, patient recruitment, monitoring/regulatory, project management (roles listed under sponsor third parties)
- Name
- IQVIA Limited
- Responsibilities
- ICSR processing and other clinical trial support duties
- Name
- WCG Clinical Inc.
- Responsibilities
- Online training portal and organisation of Virtual Investigator meeting
- Name
- Fisher Clinical Services GmbH
- Responsibilities
- IMP storage and distribution
- Name
- Eresearchtechnology Inc.
- Responsibilities
- Central ECG and eCOA
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG and eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"PPD Denmark Filial Af PPD Scandinavia AB Sverige","duties_or_roles":"Code '1' (role code present in CTIS; specific text not provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"ICSR processing; additional duties coded in sponsor duties","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Role coded '4' (specific text not provided in listing)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Online training portal and organising of Virtual Investigator meeting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Vendor management, Patient recruitment; and other coded duties","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"IMP storage and distribution","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient Travel and Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"SGS France","duties_or_roles":"Role coded '4' (specific text not provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Role coded '4' (specific text not provided)","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"Medical Data Review, and DSMB; other roles coded","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Project management duties and monitoring/regulatory","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Vyvgart 1 000 mg solution for injection in pre-filled syringe
- Active Substance
- EFGARTIGIMOD ALFA
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised (marketing authorisation EU/1/22/1674/003)
- Orphan Designation
- Yes
- Maximum Dose
- 1000 mg (maxDailyDoseAmount)
- Investigational Product Name
- Placebo PH20 SC
- Modality
- Other
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