Clinical trial • Phase II • Immunology|Dermatology|Rare Disease

EFGARTIGIMOD ALFA for Systemic sclerosis

Phase II trial of EFGARTIGIMOD ALFA for Systemic sclerosis.

Overview

Trial Therapeutic Area
Immunology|Dermatology|Rare Disease
Trial Disease
Systemic sclerosis
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
13-12-2024
First CTIS Authorization Date
15-04-2025

Trial design

Randomised, efgartigimod ph20 sc (vyvgart 1 000 mg solution for injection in pre-filled syringe) versus placebo ph20 sc (placebo matching sc pre-filled syringe); dose for vyvgart product indicated as 1000 mg (product name), schedule not specified in provided data-controlled Phase II trial in Bulgaria, Lithuania, Croatia and others.

Randomised
Yes
Comparator
Efgartigimod PH20 SC (Vyvgart 1 000 mg solution for injection in pre-filled syringe) versus placebo PH20 SC (placebo matching SC pre-filled syringe); dose for Vyvgart product indicated as 1000 mg (product name), schedule not specified in provided data
Target Sample Size
80
Trial Duration For Participant
336

Eligibility

Recruits 80 No vulnerable populations selected. Inclusion requires participants to be ≥18 years and to provide informed consent. Country-specific informed consent documents (main ICF, pregnancy ICF, caregiver ICF) are provided in multiple languages; assent is not applicable as children are not eligible..

Pregnancy Exclusion
13. Pregnant or lactating state or intention to become pregnant during the study
Vulnerable Population
No vulnerable populations selected. Inclusion requires participants to be ≥18 years and to provide informed consent. Country-specific informed consent documents (main ICF, pregnancy ICF, caregiver ICF) are provided in multiple languages; assent is not applicable as children are not eligible.

Inclusion criteria

  • {"criterion_text":"- 1. Is aged ≥18 years and the local legal age of consent for clinical studies\n- 2. Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria\n- 3. Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160\n- 4. Has a Health Assessment Questionnaire–Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3\n- 5. Has a modified Rodnan Skin Score (mRSS) score between 15 and 35\n- 6. The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening\n- 7. Has uninvolved or mildly thickened skin area in at least 1 injection site"}

Exclusion criteria

  • {"criterion_text":"- 1. Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory\n- 10. Positive serum test for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV\n- 11. Disease or any other medical condition that, in the investigator’s opinion, would confound the study results or put the participants at undue risk. Recent major surgery or intention to have major surgery during the study\n- 12. History of or current alcohol, drug, or medication abuse\n- 13. Pregnant or lactating state or intention to become pregnant during the study\n- 14. Severe renal impairment\n- 2. Significant Pulmonary Arterial Hypertension\n- 3. Severe digital vasculopathy within the past 3 months\n- 4. Skin thickening due to scleroderma mimics or localized scleroderma\n- 5. Scleroderma renal crisis within the past 6 months of participating to the study\n- 6. Another rheumatic autoimmune disease, except for secondary Sjögren’s syndrome or fibromyalgia\n- 7. Another known autoimmune disease or any medical condition that would interfere with an accurate assessment of SSc or puts the participant at undue risk\n- 8. History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 3 years or more before first IMP administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer\n- 9. Serious or severe active infection that is not sufficiently resolved before baseline OR an active infection that could place the participant at undue risk or confound the study results in the investigator’s opinion"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in modified Rodnan Skin Score (mRSS) at week 24","definition_or_measurement_approach":"Change from baseline in modified Rodnan Skin Score (mRSS) measured at baseline and week 24"}

Secondary endpoints

  • {"endpoint_text":"- 1. Change from baseline in mRSS at week 48","definition_or_measurement_approach":"Change from baseline in mRSS measured at baseline and week 48"}
  • {"endpoint_text":"- 2. Incidence and severity of treatment-emergent adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation of investigational medicinal product (IMP)","definition_or_measurement_approach":"Recording and classification of treatment-emergent AEs, SAEs, and AEs leading to IMP discontinuation over the study period"}
  • {"endpoint_text":"- 3. Clinically meaningful changes in laboratory parameters, electrocardiograms (ECGs), and vital signs","definition_or_measurement_approach":"Assessment of clinically meaningful changes from baseline in laboratory tests, ECGs, and vital signs"}
  • {"endpoint_text":"- 4. Proportion of participants who improve in ≥2 or ≥3 of the 5 core items of CRISS-25 at weeks 24 and 48 and do not have worsening in >1 component and have no significant SSc-related event(s)","definition_or_measurement_approach":"Proportion meeting composite CRISS-25 improvement criteria at weeks 24 and 48 without worsening in >1 component and no significant SSc events"}
  • {"endpoint_text":"- 5. Change from baseline in Health Assessment Questionnaire—Disability Index (HAQ-DI) at weeks 24 and 48","definition_or_measurement_approach":"Change from baseline in HAQ-DI scores measured at weeks 24 and 48"}
  • {"endpoint_text":"- 6. Change from baseline in Patient Global Assessment (PGA) at weeks 24 and 48","definition_or_measurement_approach":"Change from baseline in PGA measured at weeks 24 and 48"}
  • {"endpoint_text":"- 7. Change from baseline in Clinician’s Global Assessment (CGA) at weeks 24 and 48","definition_or_measurement_approach":"Change from baseline in CGA measured at weeks 24 and 48"}
  • {"endpoint_text":"- 8. Annualized rate of decline in forced vital capacity (FVC; in mL) in participants with interstitial lung disease (ILD)","definition_or_measurement_approach":"Annualized rate of decline in FVC (mL) for participants with ILD assessed over study duration"}
  • {"endpoint_text":"- 9. Efgartigimod serum concentrations over time","definition_or_measurement_approach":"Measurement of efgartigimod serum concentrations at predefined timepoints"}
  • {"endpoint_text":"- 10. Percent change from baseline in total IgG levels in serum over time","definition_or_measurement_approach":"Percent change from baseline in total serum IgG measured longitudinally"}
  • {"endpoint_text":"- 11. Incidence and prevalence of antidrug antibodies (ADA) against efgartigimod in serum over time","definition_or_measurement_approach":"Incidence and prevalence of ADA measured in serum over time"}
  • {"endpoint_text":"- 12. Incidence and prevalence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20) in plasma over time","definition_or_measurement_approach":"Incidence and prevalence of anti-rHuPH20 antibodies measured in plasma over time"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
80
Recruitment Window Months
24
Consent Approach
Informed consent obtained from each participant (participants must be ≥18 years). Main ICF and pregnancy ICF documents are provided; caregiver ICFs and country-specific ICFs are available in multiple languages (documents listed per country). Assent not applicable because children are not eligible.

Methods

  • Patient-facing printed materials (patient flyers, recruitment brochures) localized by country (documents labeled e.g., Patient-Flyer, Recruitment-Brochure for multiple countries)
  • Doctor-to-patient letters / GP letters for clinician-mediated recruitment (country-specific doctor-to-patient letters present)
  • Study awareness posts and website screenshots for online/public awareness (country-specific Study-Awareness-Post and website screenshots documents)
  • Scout/third-party recruitment communications and email campaigns (documents: Scout-Email-Comm, Scout-Pass materials) and vendor-supported outreach
  • Country-specific recruitment/informed consent procedures (K1 recruitment arrangements documents per country)

Geography

Total Number Of Sites
45
Total Number Of Participants
119

Bulgaria

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
17-04-2025
Processing Time Days
90
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Medical Center Artmed Ltd.
Principal Investigator Name
Mariela Geneva-Popova
Principal Investigator Email
dr.mariela.geneva@gmail.com
Contact Person Name
Mariela Geneva-Popova
Contact Person Email
dr.mariela.geneva@gmail.com
Site Name
Diagnostics And Consultation Center Convex Ltd.
Principal Investigator Name
Vladimira Boyadzhieva
Principal Investigator Email
vladimira.boyadzhieva@gmail.com
Contact Person Name
Vladimira Boyadzhieva

Lithuania

Earliest CTIS Part Ii Submission Date
17-03-2025
Latest Decision Or Authorization Date
16-04-2025
Processing Time Days
30
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Klaipedos universiteto ligonine VšĮ
Principal Investigator Name
Loreta Loreta Bukauskienė
Principal Investigator Email
l.bukauskiene@kul.lt
Contact Person Name
Loreta Loreta Bukauskienė
Contact Person Email
l.bukauskiene@kul.lt
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Reumatologijos skyrius
Principal Investigator Name
Asta Baranauskaitė
Principal Investigator Email
asta.baranauskaite@kaunoklinikos.lt
Contact Person Name
Asta Baranauskaitė

Croatia

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
95
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Opca Bolnica Zadar
Department Name
Department of Internal Medicine
Principal Investigator Name
Kristina Frketic Marovic
Principal Investigator Email
kristina.frketic.marovic@bolnica-zadar.hr
Contact Person Name
Kristina Frketic Marovic
Site Name
Klinicki Bolnicki Centar Osijek
Department Name
Rheumatology, Allergology and Clinical Immunology
Principal Investigator Name
Jasminka Milas-Ahic
Principal Investigator Email
milas-ahic.jasminka@kbco.hr
Contact Person Name
Jasminka Milas-Ahic
Contact Person Email
milas-ahic.jasminka@kbco.hr
Site Name
KBC Split
Department Name
Department of Internal Medicine
Principal Investigator Name
Mislav Radic
Principal Investigator Email
mradic@kbsplit.hr
Contact Person Name
Mislav Radic
Contact Person Email
mradic@kbsplit.hr

Belgium

Earliest CTIS Part Ii Submission Date
21-03-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
25
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Reumatologie
Principal Investigator Name
Vanessa Smith
Principal Investigator Email
vanessa.smith@ugent.com
Contact Person Name
Vanessa Smith
Contact Person Email
vanessa.smith@ugent.com
Site Name
UZ Brussel
Department Name
Reumatologie
Principal Investigator Name
Karin Melsens
Principal Investigator Email
karin.melsens@uzbrussel.be
Contact Person Name
Karin Melsens
Contact Person Email
karin.melsens@uzbrussel.be

Czechia

Earliest CTIS Part Ii Submission Date
02-04-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
13
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Revmatologicky Ustav
Department Name
Ambulantní část klinického oddělení Oddělení experimentální revmatologie
Principal Investigator Name
Michal Tomčík
Principal Investigator Email
tomcik@revma.cz
Contact Person Name
Michal Tomčík
Contact Person Email
tomcik@revma.cz

Denmark

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
8
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Rigshospitalet
Department Name
Center for Rheumatology and Spine Diseases
Principal Investigator Name
Søren Jacobsen
Principal Investigator Email
Soeren.Jacobsen.01@regionh.dk
Contact Person Name
Søren Jacobsen
Contact Person Email
Soeren.Jacobsen.01@regionh.dk

France

Earliest CTIS Part Ii Submission Date
10-02-2025
Latest Decision Or Authorization Date
16-04-2025
Processing Time Days
65
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Rhumatologie
Principal Investigator Name
Marie-Elise TRUCHETET
Principal Investigator Email
marie-elise.truchetet@chu-bordeaux.fr
Contact Person Name
Marie-Elise TRUCHETET
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Rhumatologie
Principal Investigator Name
Yannick ALLANORE
Principal Investigator Email
Yannick.allanore@aphp.fr
Contact Person Name
Yannick ALLANORE
Contact Person Email
Yannick.allanore@aphp.fr
Site Name
Hopital Huriez
Department Name
Service de Médecine Interne
Principal Investigator Name
Vincent SOBANSKI
Principal Investigator Email
vincent.sobanski@chru-lille.fr
Contact Person Name
Vincent SOBANSKI
Contact Person Email
vincent.sobanski@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Unité d’Immunologie Clinique et Thérapeutique ostéo-articulaire
Principal Investigator Name
Christian JORGENSEN
Principal Investigator Email
c-jorgensen@chu-montpellier.fr
Contact Person Name
Christian JORGENSEN
Contact Person Email
c-jorgensen@chu-montpellier.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Rhumatologie
Principal Investigator Name
Emmanuel CHATELUS
Principal Investigator Email
emmanuel.chatelus@chru-strasbourg.fr
Contact Person Name
Emmanuel CHATELUS

Germany

Earliest CTIS Part Ii Submission Date
12-03-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
34
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Rheumatologie und klinische Immunologie
Principal Investigator Name
Gabriela Riemekasten
Principal Investigator Email
gabriela.riemekasten@uksh.de
Contact Person Name
Gabriela Riemekasten
Contact Person Email
gabriela.riemekasten@uksh.de
Site Name
Klinikum Bad Bramstedt GmbH
Department Name
Klinik für Rheumatologie und Immunologie
Principal Investigator Name
Ina Kötter
Principal Investigator Email
ina.koetter@klinikumbb.de
Contact Person Name
Ina Kötter
Contact Person Email
ina.koetter@klinikumbb.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Universitätsklinik Abt. II - Rheumatologie
Principal Investigator Name
Jörg Henes
Principal Investigator Email
oerg.henes@med.uni-tuebingen.de
Contact Person Name
Jörg Henes
Site Name
Johannes Wesling Klinikum Minden
Department Name
Klinik für Rheumatologie/Klinische Immunologie
Principal Investigator Name
Gunter Aßmann
Contact Person Name
Gunter Aßmann

Greece

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
88
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Olympion Therapeftirio General Clinic Of Patras S.A.
Department Name
Rheumatology
Principal Investigator Name
Andreas Bounas
Principal Investigator Email
andbounas@gmail.com
Contact Person Name
Andreas Bounas
Contact Person Email
andbounas@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Rheumatology
Principal Investigator Name
Dimitrios Daousis
Principal Investigator Email
jimdaoussis@hotmail.com
Contact Person Name
Dimitrios Daousis
Contact Person Email
jimdaoussis@hotmail.com
Site Name
Euromedica Kyanous Stavros
Department Name
Rheumatology
Principal Investigator Name
Lukas Settas
Principal Investigator Email
loukassettas@gmail.com
Contact Person Name
Lukas Settas
Contact Person Email
loukassettas@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
06-03-2025
Latest Decision Or Authorization Date
16-04-2025
Processing Time Days
41
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
University Of Pecs
Department Name
Clinic of Rheumatology and Immunology
Principal Investigator Name
Gábor KUMÁNOVICS
Principal Investigator Email
kumanovics.gabor@pte.hu
Contact Person Name
Gábor KUMÁNOVICS
Contact Person Email
kumanovics.gabor@pte.hu

Italy

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
16-04-2025
Processing Time Days
68
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Division of Rheumatology and Clinical Immunology
Principal Investigator Name
Maria De Santis
Principal Investigator Email
maria.de_santis@hunimed.eu
Contact Person Name
Maria De Santis
Contact Person Email
maria.de_santis@hunimed.eu
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare
Principal Investigator Name
Marco Matucci Cerinic
Principal Investigator Email
matuccicerinic.marco@hsr.it
Contact Person Name
Marco Matucci Cerinic
Contact Person Email
matuccicerinic.marco@hsr.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
U.O.C. Reumatologia
Principal Investigator Name
Giovanna Cuomo
Principal Investigator Email
giovanna.cuomo@unicampania.it
Contact Person Name
Giovanna Cuomo
Contact Person Email
giovanna.cuomo@unicampania.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SODc Reumatologia, Dipartimento di Medicina Sperimentale e Clinica
Principal Investigator Name
Silvia Bellando Randone
Principal Investigator Email
silvia.bellandorandone@unifi.it
Contact Person Name
Silvia Bellando Randone
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
U.O. di Immunoreumatologia
Principal Investigator Name
Roberto Giacomelli
Principal Investigator Email
r.giacomelli@policlinicocampus.it
Contact Person Name
Roberto Giacomelli
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Reumatologia
Principal Investigator Name
Maria Antonietta D'Agostino
Contact Person Name
Maria Antonietta D'Agostino
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
S.C. di Reumatologia
Principal Investigator Name
Dilia Giuggioli
Principal Investigator Email
dilia.giuggioli@unimore.it
Contact Person Name
Dilia Giuggioli
Contact Person Email
dilia.giuggioli@unimore.it

Netherlands

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
95
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Rheumatology
Principal Investigator Name
Jeska K. De Vries - Bouwstra
Principal Investigator Email
j.k.de_vries-bouwstra@lumc.nl
Contact Person Name
Jeska K. De Vries - Bouwstra
Contact Person Email
j.k.de_vries-bouwstra@lumc.nl

Poland

Earliest CTIS Part Ii Submission Date
09-04-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
13
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Reumed Sp. z o.o.
Department Name
Zespół Poradni Specjalistycznych REUMED- Filia nr 1 Wallenroda
Principal Investigator Name
Robert Zwolak
Principal Investigator Email
zwolakr@wp.pl
Contact Person Name
Robert Zwolak
Contact Person Email
zwolakr@wp.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o
Principal Investigator Name
Piotr Wiland
Principal Investigator Email
pwiland1@gmail.com
Contact Person Name
Piotr Wiland
Contact Person Email
pwiland1@gmail.com
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Principal Investigator Name
Bogdan Batko
Principal Investigator Email
bpbatko@gmail.com
Contact Person Name
Bogdan Batko
Contact Person Email
bpbatko@gmail.com
Site Name
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Małgorzata Miakisz
Principal Investigator Email
miakisz@twojaprzychodnia.com
Contact Person Name
Małgorzata Miakisz
Contact Person Email
miakisz@twojaprzychodnia.com
Site Name
MICS Centrum Medyczne Warszawa, Medicover Integrated Clinical Services Sp. z o.o
Principal Investigator Name
Katarzyna Romanowska-Próchnicka
Principal Investigator Email
kontakt@medycynakliniczna.pl
Contact Person Name
Katarzyna Romanowska-Próchnicka
Contact Person Email
kontakt@medycynakliniczna.pl

Romania

Earliest CTIS Part Ii Submission Date
03-04-2025
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
19
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Saint Maria Hospital
Department Name
Reumathology
Principal Investigator Name
Florian Berghea
Principal Investigator Email
berghea1@gmail.com
Contact Person Name
Florian Berghea
Contact Person Email
berghea1@gmail.com
Site Name
Spitalul Clinic Dr. I. Cantacuzino
Department Name
Clinical Internal Medicine and Rheumatology
Principal Investigator Name
Ana-Maria Gheorghiu
Principal Investigator Email
ana.gherghe@gmail.com
Contact Person Name
Ana-Maria Gheorghiu
Contact Person Email
ana.gherghe@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
67
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Hospital Del Mar
Department Name
Servicio de Reumatologia
Principal Investigator Name
Ana Pros Simon
Principal Investigator Email
apros@parcdesalutmar.cat
Contact Person Name
Ana Pros Simon
Contact Person Email
apros@parcdesalutmar.cat
Site Name
Parc Tauli Hospital Universitari
Department Name
Servicio de Reumatologia
Principal Investigator Name
Joan Calvet Fontova
Principal Investigator Email
calvet.parctauli@gmail.com
Contact Person Name
Joan Calvet Fontova
Contact Person Email
calvet.parctauli@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Servicio de Reumatologia
Principal Investigator Name
Rafaela Ortega Castro
Principal Investigator Email
orcam84@hotmail.com
Contact Person Name
Rafaela Ortega Castro
Contact Person Email
orcam84@hotmail.com

Portugal

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
53
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Reumathology
Principal Investigator Name
Tiago Meirinhos
Principal Investigator Email
tiago.meirinhos@ulsge.min-saude.pt
Contact Person Name
Tiago Meirinhos
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Reumathology
Principal Investigator Name
Catarina Resende
Principal Investigator Email
catarinalopesresende@gmail.com
Contact Person Name
Catarina Resende
Contact Person Email
catarinalopesresende@gmail.com
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Reumathology
Principal Investigator Name
Manuela Costa
Principal Investigator Email
mmcosta@ulslo.min-saude.pt
Contact Person Name
Manuela Costa
Contact Person Email
mmcosta@ulslo.min-saude.pt

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD Global Ltd.
Responsibilities
Duties include codes 1,12,15 (value: CRO),5 — listed responsibilities include CRO role and other vendor activities

Third parties

  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Clinical Outcomes Solutions LLC","duties_or_roles":"sponsorDuties code 15, value: Exit Interview","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"sponsorDuties code 15, value: Spirometry service","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"sponsorDuties codes: 1,12,15 (value: CRO),5","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"UZGent","duties_or_roles":"sponsorDuties code 15, value: NVC analysis","organisation_type":"Health care"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties code 15, value: Home Trial Services","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Universitätsklinikum Düsseldorf AöR, Forschungslabore der Frauenklinik","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Health care"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"sponsorDuties code 15, value: PK and Immuno Efgartigimod","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code 15, value: Nailfold Video Capillaroscopy (NVC) service","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties code 15, value: patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 3,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"PPD Romania S.R.L.","duties_or_roles":"sponsorDuties code 15, value: Long term storage of study samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"sponsorDuties codes: 10,6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"EndPoint Clinical Inc.","duties_or_roles":"sponsorDuties code 15, value: Interactive Response Technology vendor","organisation_type":"Health care"}
  • {"country":"United States","full_name":"PPD Development LP (additional entry)","duties_or_roles":"sponsorDuties codes: 1,11,12,13,15 (value: Vendor Management),2,4,5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"AML (Algemeen medisch labo)","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code 15, value: spirometry, eCOA services, ECG service","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties code 15, value: Long term storage of study samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties code 15, value: IMP shipment, packaging","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
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketing authorisation EU/1/22/1674/003)
Starting Dose
1000 mg (product name indicates 1 000 mg)
Maximum Dose
1000 mg (maxDailyDoseAmount)
Investigational Product Name
placebo PH20 SC PFS
Modality
Other
Combination Treatment
Yes

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