Clinical trial • Phase II • Neurology

EFGARTIGIMOD ALFA for Chronic inflammatory demyelinating polyneuropathy

Phase II trial of EFGARTIGIMOD ALFA for Chronic inflammatory demyelinating polyneuropathy. open-label, none/not specified-controlled. 148 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Chronic inflammatory demyelinating polyneuropathy
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
27-11-2023
First CTIS Authorization Date
23-01-2024

Trial design

open-label, none/not specified-controlled Phase II trial in Germany, Denmark, Austria and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
148
Trial Duration For Participant
336

Eligibility

Recruits 148 Vulnerable population selected. Patients must provide written informed consent. Caregiver informed consent forms are available (Caregiver ICF documents are listed in the submission). No separate assent procedures for minors are described in the available documents; trial population and public title indicate adults only..

Pregnancy Exclusion
Pregnant and lactating women and those intending to become pregnant during the trial.
Vulnerable Population
Vulnerable population selected. Patients must provide written informed consent. Caregiver informed consent forms are available (Caregiver ICF documents are listed in the submission). No separate assent procedures for minors are described in the available documents; trial population and public title indicate adults only.

Inclusion criteria

  • {"criterion_text":"- 1. Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial."}
  • {"criterion_text":"- 2. Male or female patient with 1 of the following options: - Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or - Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or - Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or - Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment."}
  • {"criterion_text":"- 3. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration."}
  • {"criterion_text":"- 4. Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last dose of IMP"}

Exclusion criteria

  • {"criterion_text":"- 1. Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP."}
  • {"criterion_text":"- 2. Pregnant and lactating women and those intending to become pregnant during the trial."}
  • {"criterion_text":"- 3. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of TEAEs and SAEs by system organ class (SOC) and preferred term (PT). TEAEs and SAEs are monitored throughout the entire study duration.","definition_or_measurement_approach":"Monitoring and summarising incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by SOC and PT throughout the entire study duration."}
  • {"endpoint_text":"- Incidence of clinically significant laboratory abnormalities. Blood sampling for laboratory analysis is taken at every study visit.","definition_or_measurement_approach":"Assessment of clinically significant laboratory abnormalities via blood samples taken at every study visit."}

Secondary endpoints

  • {"endpoint_text":"- Efficacy; Change from baseline over time in the following scores and measurements: − Adjusted INCAT score; − MRC Sum score; − 24-item I-RODS disability scores; − Mean grip strength assessed by Martin vigorimeter; − TUG score. Percentage of patients without clinical deterioration over time, defined by adjusted INCAT increase ≥1 point compared to baseline.","definition_or_measurement_approach":"Change from baseline over time in specified clinical scores (adjusted INCAT, MRC sum, 24-item I-RODS, mean grip strength by Martin vigorimeter, TUG). Clinical deterioration defined as adjusted INCAT increase ≥1 point vs baseline; outcomes assessed over time at scheduled visits."}
  • {"endpoint_text":"- Immunogenicity; - Percentage of patients with and titers of binding antibodies (BAb) towards efgartigimod; and the presence of neutralizing antibodies (NAb) against efgartigimod.","definition_or_measurement_approach":"Measurement of binding antibody (BAb) incidence and titers against efgartigimod and assessment of presence of neutralizing antibodies (NAb)."}
  • {"endpoint_text":"- Pharmacokinetics; - Efgartigimod serum concentrations (during the first 48-week treatment cycle [followed by a safety follow-up period, if applicable]).","definition_or_measurement_approach":"Serial measurement of efgartigimod serum concentrations during the first 48-week treatment cycle; PK sampling schedule as per protocol."}
  • {"endpoint_text":"- Pharmacodynamics; - Changes from baseline over time of serum IgG levels (total). Efficacy, immunogenicity, pharmacokinetic and pharmacodynamic endpoints are assessed at every study visit","definition_or_measurement_approach":"Measurement of total serum IgG changes from baseline over time; PD assessed at every study visit alongside efficacy, immunogenicity and PK endpoints."}
  • {"endpoint_text":"- Additional Patient-reported Outcome; Change from baseline over time in: − Health-related quality-of-life questionnaire (EQ-5D-5L); − Brief Pain Inventory – Short Form (BPI-SF); − 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9); − Rasch-transformed-Fatigue Severity Scale (RT-FSS); − Hospital Anxiety and Depression Scale (HADS). Patient report outcomes are assessed at every study visit with the exception of visit 2 (week 4)","definition_or_measurement_approach":"Change from baseline over time in listed PRO instruments (EQ-5D-5L, BPI-SF, TSQM-9, RT-FSS, HADS); PROs assessed at every study visit except visit 2 (week 4)."}
  • {"endpoint_text":"- Percentage of patients performing self-administration over time.","definition_or_measurement_approach":"Proportion of patients who self-administer treatment over time (tracked across visits)."}
  • {"endpoint_text":"- Percentage of patients with treatment administered by caregiver over time.","definition_or_measurement_approach":"Proportion of patients whose treatment is administered by a caregiver over time (tracked across visits)."}
  • {"endpoint_text":"- This is mock end point to allow the upload of the full translation of endpoint number 5.","definition_or_measurement_approach":"Administrative/mock endpoint to allow upload of translations; no clinical measurement approach."}
  • {"endpoint_text":"- This is mock end point to allow the upload of the full translation of endpoint number 1.","definition_or_measurement_approach":"Administrative/mock endpoint to allow upload of translations; no clinical measurement approach."}

Recruitment

Planned Sample Size
148
Recruitment Window Months
84
Consent Approach
Written informed consent is required from each patient prior to participation (including consent for use and disclosure of research-related health information). Caregiver informed consent forms are available (Caregiver ICF documents included in submission). Pregnancy-and-birth information/ICF documents are provided. Multiple language versions of ICFs and study documents are available (examples include German, French, English, Spanish, Dutch, Polish, Italian, Romanian, Bulgarian). No separate assent procedures for minors are described; the study population and documents indicate adult participants.

Geography

Total Number Of Sites
40
Total Number Of Participants
88

Germany

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
25-01-2024
Processing Time Days
38
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
University Hospital Cologne AöR
Department Name
Department of Neurology
Principal Investigator Name
Michael Schroeter
Principal Investigator Email
michael.schroeter@uk-koeln.de
Contact Person Name
Michael Schroeter
Contact Person Email
michael.schroeter@uk-koeln.de
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Klinik für Neurologie
Principal Investigator Name
Frank Leypoldt
Principal Investigator Email
frank.leypoldt@uksh.de
Contact Person Name
Frank Leypoldt
Contact Person Email
frank.leypoldt@uksh.de
Site Name
St. Josef-Hospital
Principal Investigator Name
Olaf Hoffmann
Principal Investigator Email
o.hoffmann@alexianer.de
Contact Person Name
Olaf Hoffmann
Contact Person Email
o.hoffmann@alexianer.de

Denmark

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
24-01-2024
Processing Time Days
37
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Aarhus Universitetshospital
Department Name
Department Neurology, J109
Principal Investigator Name
Thomas Harbo
Principal Investigator Email
thomas.harbo@rm.dk
Contact Person Name
Thomas Harbo
Contact Person Email
thomas.harbo@rm.dk
Site Name
Odense University Hospital
Department Name
Department Neurology, N indgang 17 stuen
Principal Investigator Name
Søren Sindrup
Principal Investigator Email
soeren.sindrup@rsyd.dk
Contact Person Name
Søren Sindrup
Contact Person Email
soeren.sindrup@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department Neurology 8077
Principal Investigator Name
Tina Dysgaard Jeppesen
Principal Investigator Email
tina.dysgaard.jeppesen.03@regionh.dk
Contact Person Name
Tina Dysgaard Jeppesen

Austria

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
05-02-2024
Processing Time Days
49
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Johannes Kepler University
Principal Investigator Name
Christian Eggers
Principal Investigator Email
Christian.Eggers@kepleruniklinikum.at
Contact Person Name
Christian Eggers
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

Romania

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
29-01-2024
Processing Time Days
42
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Teo Health S.A.
Department Name
Neurology Clinical Department
Principal Investigator Name
Ana-Maria Scutaru-Kadar
Principal Investigator Email
anascutarukadar@gmail.com
Contact Person Name
Ana-Maria Scutaru-Kadar
Contact Person Email
anascutarukadar@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Department Name
Neurology II Clinical Department
Principal Investigator Name
Mihaela-Adriana Simu
Principal Investigator Email
mihaelasimu6713@gmail.com
Contact Person Name
Mihaela-Adriana Simu
Contact Person Email
mihaelasimu6713@gmail.com
Site Name
Neurocity S.R.L.
Department Name
Neurology
Principal Investigator Name
Dan-Andrei Mitrea
Principal Investigator Email
dan.mitrea@neuroaxis.ro
Contact Person Name
Dan-Andrei Mitrea
Contact Person Email
dan.mitrea@neuroaxis.ro

Bulgaria

Earliest CTIS Part Ii Submission Date
27-02-2024
Latest Decision Or Authorization Date
26-03-2024
Processing Time Days
28
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Diagnostics And Consultation Center Convex Ltd.
Principal Investigator Name
Krasimir Genov
Principal Investigator Email
kr_genov@abv.bg
Contact Person Name
Krasimir Genov
Contact Person Email
kr_genov@abv.bg
Site Name
Military Medical Academy
Department Name
Department of Neurological Diseases
Principal Investigator Name
Plamen Tsvetanov
Principal Investigator Email
tzvetanovplamen@hotmail.com
Contact Person Name
Plamen Tsvetanov
Contact Person Email
tzvetanovplamen@hotmail.com
Site Name
Alexandrovska University Hospital
Department Name
Clinic of Neurological Diseases
Principal Investigator Name
Ivaylo Tarnev
Principal Investigator Email
itournev@emhpf.org
Contact Person Name
Ivaylo Tarnev
Contact Person Email
itournev@emhpf.org

Belgium

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
23-01-2024
Processing Time Days
36
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Neurology
Principal Investigator Name
Stephanie Delstanche
Principal Investigator Email
stephanie.delstanche@chrcitadelle.be
Contact Person Name
Stephanie Delstanche
Site Name
Cliniques Universitaires Saint-Luc
Principal Investigator Name
Vinciane Van Parys
Principal Investigator Email
vinciane.vanparijs@uclouvain.be
Contact Person Name
Vinciane Van Parys
Site Name
Antwerp University Hospital
Department Name
Neurology
Principal Investigator Name
Jonathan Baets
Principal Investigator Email
jonathan.baets@uza.be
Contact Person Name
Jonathan Baets
Contact Person Email
jonathan.baets@uza.be
Site Name
UZ Leuven
Principal Investigator Name
Kristl Claeys
Principal Investigator Email
kristl.claeys@uzleuven.be
Contact Person Name
Kristl Claeys
Contact Person Email
kristl.claeys@uzleuven.be

Poland

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
23-02-2024
Processing Time Days
67
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Centrum Neurologii Krzysztof Selmaj
Principal Investigator Name
Krzysztof Selmaj
Principal Investigator Email
centrum.neurologii.k.selmaj@gmail.com
Contact Person Name
Krzysztof Selmaj
Site Name
Michalski I Partnerzy Lekarze sp.p.
Principal Investigator Name
Agnieszka Kułaga
Principal Investigator Email
kulaga_a@poczt.onet.pl
Contact Person Name
Agnieszka Kułaga
Contact Person Email
kulaga_a@poczt.onet.pl
Site Name
Clinirem Sp. z o.o.
Principal Investigator Name
Urszula Chyrchel - Paszkiewicz
Principal Investigator Email
pgluchyrchel@gmail.coml
Contact Person Name
Urszula Chyrchel - Paszkiewicz
Contact Person Email
pgluchyrchel@gmail.coml

Spain

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
29-01-2024
Processing Time Days
42
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Principal Investigator Name
Luis Antonio Querol Gutierrez
Principal Investigator Email
lquerol@santpau.cat
Contact Person Name
Luis Antonio Querol Gutierrez
Contact Person Email
lquerol@santpau.cat
Site Name
Hospital Clinico San Carlos
Department Name
Neurology
Principal Investigator Name
Antonio Guerrero Sola
Principal Investigator Email
aguerrero.hcsc@salud.madrid.org
Contact Person Name
Antonio Guerrero Sola
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

Netherlands

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
26-01-2024
Processing Time Days
39
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Amsterdam UMC
Department Name
Neurology
Principal Investigator Name
Filip Eftimov
Principal Investigator Email
f.eftimov@amc.uva.nl
Contact Person Name
Filip Eftimov
Contact Person Email
f.eftimov@amc.uva.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Neurology
Principal Investigator Name
Krista Kuitwaard
Principal Investigator Email
k.kuitwaard@erasmusmc.nl
Contact Person Name
Krista Kuitwaard
Contact Person Email
k.kuitwaard@erasmusmc.nl

France

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
23-01-2024
Processing Time Days
36
Number Of Sites
7
Number Of Participants
8

Sites

Site Name
CHU Gabriel-Montpied
Department Name
Service de neurologie
Principal Investigator Name
Frédéric TAITHE
Principal Investigator Email
ftaithe@chuclermontferrand.fr
Contact Person Name
Frédéric TAITHE
Contact Person Email
ftaithe@chuclermontferrand.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hôpital Pellegrin , Département de Neurologie
Principal Investigator Name
Gwendal LE MASSON
Principal Investigator Email
gwendal.le-masson@chubordeaux.fr
Contact Person Name
Gwendal LE MASSON
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Département de Neurologie
Principal Investigator Name
Laurent MAGY
Principal Investigator Email
laurent.magy@unilim.fr
Contact Person Name
Laurent MAGY
Contact Person Email
laurent.magy@unilim.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hôpital de Hautepierre, Service de Neurologie
Principal Investigator Name
Jérôme DE SEZE
Principal Investigator Email
jerome.de.seze@chrustrasbourg.fr
Contact Person Name
Jérôme DE SEZE
Site Name
Hospital Hotel Dieu
Department Name
Laboratoire d’Explorations Fonctionnelles, Centre de référence des maladie
Principal Investigator Name
Yann PEREON
Principal Investigator Email
yann.pereon@univnantes.fr
Contact Person Name
Yann PEREON
Contact Person Email
yann.pereon@univnantes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de neurophysiologie clinique et Association Institut de Myologie
Principal Investigator Name
Rabab DEBS
Principal Investigator Email
rabab.debs@aphp.fr
Contact Person Name
Rabab DEBS
Contact Person Email
rabab.debs@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hôpital Pasteur 2,Département de Neurologie / Centre de Référence des Maladies Neuromusculaires et
Principal Investigator Name
Sabrina SACCONI
Principal Investigator Email
sacconi.s@chu-nice.fr
Contact Person Name
Sabrina SACCONI
Contact Person Email
sacconi.s@chu-nice.fr

Italy

Earliest CTIS Part Ii Submission Date
18-12-2023
Latest Decision Or Authorization Date
05-02-2024
Processing Time Days
49
Number Of Sites
7
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
Neurologia 1 U
Principal Investigator Name
Adriano Chiò
Principal Investigator Email
adriano.chio@unito.it
Contact Person Name
Adriano Chiò
Contact Person Email
adriano.chio@unito.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
U.O.C Neurologia e malattie neuromuscolari
Principal Investigator Name
Anna Mazzeo
Principal Investigator Email
anna.mazzeo@polime.it
Contact Person Name
Anna Mazzeo
Contact Person Email
anna.mazzeo@polime.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UO Neurologia
Principal Investigator Name
Francesca Maria Benedetta Magri
Principal Investigator Email
francesca.magri@policlinico.mi.it
Contact Person Name
Francesca Maria Benedetta Magri
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. Neurologia
Principal Investigator Name
Alessandro Padovani
Principal Investigator Email
alessandro.padovani@unibs.it
Contact Person Name
Alessandro Padovani
Contact Person Email
alessandro.padovani@unibs.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC Neurologia - Ambulatorio Malattie Neuromuscolari
Principal Investigator Name
Giulia Ricci
Principal Investigator Email
giulia.ricci@med.unipi.it
Contact Person Name
Giulia Ricci
Contact Person Email
giulia.ricci@med.unipi.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
UOC Neurologia 3, Neuroalgologia
Principal Investigator Name
Giuseppe Lauria Pinter
Principal Investigator Email
giuseppe.lauriapinter@istituto-besta.it
Contact Person Name
Giuseppe Lauria Pinter
Site Name
Careggi University Hospital
Department Name
Neurologia 1 Dipartimento Neuromuscoloscheletrico e degli organi di senso
Principal Investigator Name
Sabrina Matà
Principal Investigator Email
sabrina.mata@aouc.unifi.it
Contact Person Name
Sabrina Matà
Contact Person Email
sabrina.mata@aouc.unifi.it

Sponsor

Primary sponsor

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

Contract research organisations

Name
Drug Development Solutions Limited
Responsibilities
Pharmacokinecics, Pharmacodynamics, Antidrug
Name
IQVIA Limited
Responsibilities
Safety reporting to Regulatory Authorities, Ethics Committees; Safety reporting from Investigators
Name
Pharmaceutical Product Development LLC
Responsibilities
Transport of patient samples from home address to site for home visits under protocol Section 11.8
Name
PPD Global Limited / PPD International Holdings LLC
Responsibilities
Clinical trial services (listed among third parties; transport/logistics and other CRO duties)
Name
Fisher Clinical Services GmbH
Responsibilities
Shipment of IMP and related logistics

Third parties

  • {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"Pharmacokinecics, Pharmacodynamics, Antidrug","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"Telehealth visits for home visits conducted as per protocol Section 11.8 (Appendix 11)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Safety reporting to Regulatory Authorities, Ethics Committees; Safety reporting from Investigators","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term storage of biological samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"rHuPH20 immunogenicity testing","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Home health care","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"PPD online training portal","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic patient-reported outcome solution","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Transport of patient samples from home address to site for home visits under protocol Section 11.8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"","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":"Switzerland","full_name":"Fisher Clinical Services GmbH (Switzerland address)","duties_or_roles":"Shipment of IMP to patient's home address for home visits under protocol Section 11.8 (Appendix 11)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Efgartigimod
Active Substance
EFGARTIGIMOD ALFA
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (prodAuthStatus=1)
Orphan Designation
Yes
Starting Dose
1000 mg
Frequency
Weekly (1000 mg) or less frequently as per dosing frequency substudy
Maximum Dose
1000 mg (maxDailyDoseAmount=1000)
Investigational Product Name
ARGX-113
Active Substance
EFGARTIGIMOD ALFA
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (prodAuthStatus=1)
Orphan Designation
Yes
Starting Dose
1000 mg
Frequency
Weekly (1000 mg) or less frequently as per dosing frequency substudy
Maximum Dose
1000 mg (maxDailyDoseAmount=1000)
Combination Treatment
Yes

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