Clinical trial • Phase III • Haematology

MEZAGITAMAB for Primary immune thrombocytopenia | Chronic primary immune thrombocytopenia

Phase III trial of MEZAGITAMAB for Primary immune thrombocytopenia | Chronic primary immune thrombocytopenia.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Primary immune thrombocytopenia | Chronic primary immune thrombocytopenia
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
30-06-2025
First CTIS Authorization Date
22-10-2025

Trial design

Randomised, experimental arm: mezagitamab (investigational product); comparator arm: placebo matching for mezagitamab (placebo comparator). dose and schedule not specified in the ctis metadata provided.-controlled Phase III trial across 40 sites in Spain, Netherlands, Bulgaria and others.

Randomised
Yes
Comparator
Experimental arm: Mezagitamab (investigational product); Comparator arm: Placebo matching for Mezagitamab (placebo comparator). Dose and schedule not specified in the CTIS metadata provided.
Target Sample Size
98
Trial Duration For Participant
168

Eligibility

Recruits 98 Vulnerable population flag is selected. The trial is limited to adults (main objective states participants aged ≥18 years). Multiple subject information and informed consent forms (ICFs) are provided, including adult main ICFs and additional ICFs/templates for pregnant partners and for scout/carer (accompanying person/caregiver), indicating separate consent documents for accompanying persons/caregivers. Consent is provided by the adult participant (≥18); separate informed consent documents exist for caregiver/scout roles and for pregnancy-related procedures; country-specific language ICFs are provided..

Vulnerable Population
Vulnerable population flag is selected. The trial is limited to adults (main objective states participants aged ≥18 years). Multiple subject information and informed consent forms (ICFs) are provided, including adult main ICFs and additional ICFs/templates for pregnant partners and for scout/carer (accompanying person/caregiver), indicating separate consent documents for accompanying persons/caregivers. Consent is provided by the adult participant (≥18); separate informed consent documents exist for caregiver/scout roles and for pregnancy-related procedures; country-specific language ICFs are provided.

Inclusion criteria

  • {"criterion_text":"- The participant has been diagnosed with primary ITP that has persisted for at least 12 months. Diagnosis is in accordance with The American Society of Hematology 2019 Guidelines for ITP (Neunert et al. 2019) or the Updated International Consensus Report on The Investigation and Management of Primary ITP (Provan et al. 2019), as locally applicable."}
  • {"criterion_text":"- The participant’s diagnosis of ITP is supported by a prior response to an ITP therapy (not including a TPO-RA), defined as having achieved a platelet count ≥50,000/µL."}
  • {"criterion_text":"- The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids) and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000/µL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy."}
  • {"criterion_text":"- The participant has a mean platelet count of <30,000/µL (with individual values ≤35,000/µL) from at least 2 consecutive measurements taken at least 5 days apart during screening (and may be inclusive of Day 1), including at least 1 of those measurements within 14 days before the first dose of investigational medicinal product (IMP) (Day 1)."}
  • {"criterion_text":"- If the participant is receiving allowed standard-of-care treatment for ITP at screening and continued use is intended, treatment may continue during the trial if the dose and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (ie, Day 1) and are expected to remain stable throughout the trial. Permitted concomitant treatments may include 1 medication from each of the following 3 categories: a) One thrombopoietin receptor agonist (eg, romiplostim, eltrombopag, avatrombopag, hetrombopag), and/or b) One oral corticosteroid given daily or every other day (not to exceed prednisone 20 mg daily or equivalent dose), and/or c) Fostamatinib. If participants do not plan to continue these agents during the trial, they must be washed out."}

Exclusion criteria

  • {"criterion_text":"- The participant has secondary ITP."}
  • {"criterion_text":"- The participant has had any thrombotic or embolic event within 12 months before signing the ICF."}
  • {"criterion_text":"- The participant has had a splenectomy."}
  • {"criterion_text":"- The participant has received anti-CD20 treatment within 12 months before screening and either of the following applies: a) The last dose was received within 6 months before screening. b) The last dose was received between 6 and 12 months before screening and the participant has a CD19+ count below the lower limit of normal."}
  • {"criterion_text":"- The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day 1."}
  • {"criterion_text":"- The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected that any treatment for thrombocytopenia other than the participant’s standard-of-care ITP therapy (eg, rescue therapy, administration of blood products) may be used between screening and Day 1."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Durable platelet response through Week 24, defined as platelet count ≥50,000/μL on at least 4 of the 6 weekly platelet measurements between Week 19 and Week 24.","definition_or_measurement_approach":"Platelet count ≥50,000/μL on at least 4 of the 6 weekly platelet measurements between Week 19 and Week 24 (durable platelet response through Week 24)."}

Secondary endpoints

  • {"endpoint_text":"- 1. The cumulative number of weeks that a platelet count was ≥50,000/μL through Week 24.","definition_or_measurement_approach":"Count cumulative number of weeks with platelet count ≥50,000/μL through Week 24."}
  • {"endpoint_text":"- 2. Time to first platelet count ≥50,000/µL.","definition_or_measurement_approach":"Time-to-event: time from baseline to first recorded platelet count ≥50,000/µL."}
  • {"endpoint_text":"- 3. The cumulative number of weeks that a platelet count was ≥30,000/μL through Week 24 and at least doubled from baseline.","definition_or_measurement_approach":"Count cumulative weeks with platelet count ≥30,000/μL through Week 24 and at least 2x baseline."}
  • {"endpoint_text":"- 4. Complete platelet response, defined as a platelet count ≥100,000/µL on at least 2 visits through Week 24.","definition_or_measurement_approach":"Platelet count ≥100,000/µL on at least two visits through Week 24."}
  • {"endpoint_text":"- 5. Platelet response at Week 16, defined as a platelet count ≥50,000/µL before IMP administration at the Week 16 visit.","definition_or_measurement_approach":"Platelet count ≥50,000/µL measured pre-dose at Week 16 visit."}
  • {"endpoint_text":"- 6. Change from baseline in the Symptoms scale score of the ITP-PAQ at Week 16.","definition_or_measurement_approach":"Change from baseline in ITP-PAQ Symptoms scale score at Week 16."}
  • {"endpoint_text":"- 7. Change from baseline in the Symptoms scale score of the ITP-PAQ at Week 24.","definition_or_measurement_approach":"Change from baseline in ITP-PAQ Symptoms scale score at Week 24."}
  • {"endpoint_text":"- 8. Occurrence of receiving rescue therapy.","definition_or_measurement_approach":"Incidence (yes/no) of receiving rescue therapy during study period."}
  • {"endpoint_text":"- 9. Time to first rescue therapy.","definition_or_measurement_approach":"Time from baseline to first administration of rescue therapy."}
  • {"endpoint_text":"- 10. Presence of bleeding events, defined as Grade ≥2 in the Skin domain, or Grade ≥1 in the Mucosal domain, or Grade ≥1 in the Organ domain, in the ITP-BAT through Week 24.","definition_or_measurement_approach":"Bleeding events assessed by ITP-BAT: Grade thresholds by domain through Week 24."}
  • {"endpoint_text":"- 11. The serum concentration of mezagitamab during and after intervention.","definition_or_measurement_approach":"Measurement of serum mezagitamab concentrations (PK sampling) during and after intervention."}
  • {"endpoint_text":"- 12. Incidence of ADA and change in ADA titers.","definition_or_measurement_approach":"Incidence and titer changes of anti-drug antibodies (ADA)."}
  • {"endpoint_text":"- 13. Incidence of neutralizing ADA.","definition_or_measurement_approach":"Incidence of neutralizing anti-drug antibodies."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
98
Recruitment Window Months
25
Consent Approach
Adults (≥18 years) provide written informed consent. Multiple subject information and informed consent forms are provided, including main adult ICFs and country-specific language versions. Additional ICFs/templates exist for pregnant partners and for scout/carer (accompanying person/caregiver), indicating separate consent procedures/documents for accompanying persons. ICFs are available in country/language-specific versions (examples in Spanish, Dutch, Bulgarian, Polish, Croatian, German, Swedish, Greek, Italian, French, English as per provided documents).

Methods

  • Country-specific recruitment materials: posters, recruitment brochures, participant invitation letters and PI-to-participant letter templates.
  • Referring physician letters and physician presentations for clinician outreach.
  • Social media posts and social media post images for digital outreach.
  • Study websites and trial listings (country-specific website materials).
  • Visit guides and study overview documents provided to potential participants and sites.

Geography

Total Number Of Sites
40
Total Number Of Participants
101

Spain

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
56
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Denis Zafra Torres
Principal Investigator Email
deniszt@hotmail.com
Contact Person Name
Denis Zafra Torres
Contact Person Email
deniszt@hotmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
José Ramón González Porras
Principal Investigator Email
jrgp@usal.es
Contact Person Name
José Ramón González Porras
Contact Person Email
jrgp@usal.es
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Hematology
Principal Investigator Name
Francisco Javier Peñalver Párraga
Principal Investigator Email
franciscojavier.penalver@salud.madrid.org
Contact Person Name
Francisco Javier Peñalver Párraga
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Principal Investigator Name
Cristina Pascual Izquierdo
Principal Investigator Email
crisizquierdo3@yahoo.es
Contact Person Name
Cristina Pascual Izquierdo
Contact Person Email
crisizquierdo3@yahoo.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
María Eva Mingot-Castellano
Principal Investigator Email
mariae.mingot.sspa@juntadeandalucia.es
Contact Person Name
María Eva Mingot-Castellano

Netherlands

Earliest CTIS Part Ii Submission Date
09-10-2025
Latest Decision Or Authorization Date
24-10-2025
Processing Time Days
15
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hematology
Principal Investigator Name
A.J.G. (Gerard) Jansen
Principal Investigator Email
a.j.g.jansen@erasmusmc.nl
Contact Person Name
A.J.G. (Gerard) Jansen
Contact Person Email
a.j.g.jansen@erasmusmc.nl
Site Name
Haga Hospital
Department Name
Hematology
Principal Investigator Name
Tanja Netelenbos
Principal Investigator Email
t.netelenbos@hagaziekenhuis.nl
Contact Person Name
Tanja Netelenbos
Contact Person Email
t.netelenbos@hagaziekenhuis.nl

Bulgaria

Earliest CTIS Part Ii Submission Date
16-09-2025
Latest Decision Or Authorization Date
23-10-2025
Processing Time Days
37
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
University Multiprofile Hospital For Active Treatment Sofiamed OOD
Department Name
Department of Clinical Hematology
Principal Investigator Name
Tzvetan Alaykov
Principal Investigator Email
dr.alaikov@gmail.com
Contact Person Name
Tzvetan Alaykov
Contact Person Email
dr.alaikov@gmail.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
Department of Clinical Hematology
Principal Investigator Name
Mariya Todorova
Principal Investigator Email
dr.maria.dtodorova@gmail.com
Contact Person Name
Mariya Todorova
Contact Person Email
dr.maria.dtodorova@gmail.com
Site Name
Medical Center FAMA Medical Ltd.
Principal Investigator Name
Katya Sapunarova
Principal Investigator Email
kasapunarova@yahoo.com
Contact Person Name
Katya Sapunarova
Contact Person Email
kasapunarova@yahoo.com
Site Name
Military Medical Academy
Department Name
Clinic of Hematology
Principal Investigator Name
Viktoria Barbukova
Principal Investigator Email
viktoriia1982@abv.bg
Contact Person Name
Viktoria Barbukova
Contact Person Email
viktoriia1982@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Clinical Hematology
Principal Investigator Name
Atanas Radinoff
Principal Investigator Email
aradinoff@hotmail.com
Contact Person Name
Atanas Radinoff
Contact Person Email
aradinoff@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
76
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii Ogólnej i Chorób Wewnętrznych
Principal Investigator Name
Jacek Treliński
Principal Investigator Email
jacek.trelinski@umed.lodz.pl
Contact Person Name
Jacek Treliński
Contact Person Email
jacek.trelinski@umed.lodz.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
sgrosicki@wp.pl
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych
Principal Investigator Name
Jerzy Windyga
Principal Investigator Email
jwindyga@ihit.waw.pl
Contact Person Name
Jerzy Windyga
Contact Person Email
jwindyga@ihit.waw.pl

Croatia

Earliest CTIS Part Ii Submission Date
02-03-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
28
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
University Hospital Centre Zagreb
Principal Investigator Name
Dražen Pulanić
Principal Investigator Email
drazen.pulanic@kbc-zagreb.hr
Contact Person Name
Dražen Pulanić
Contact Person Email
drazen.pulanic@kbc-zagreb.hr

Germany

Earliest CTIS Part Ii Submission Date
20-02-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
24
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II Abteilung Hämatologie und Internistische Onkologie
Principal Investigator Name
Thomas Stauch
Principal Investigator Email
thomas.stauch@med.uni-jena.de
Contact Person Name
Thomas Stauch
Contact Person Email
thomas.stauch@med.uni-jena.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
WTZ-Ambulanz
Principal Investigator Name
Alexander Röth
Principal Investigator Email
alexander.roeth@uk-essen.de
Contact Person Name
Alexander Röth
Contact Person Email
alexander.roeth@uk-essen.de

Sweden

Earliest CTIS Part Ii Submission Date
20-02-2026
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
19
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO Hematologi
Principal Investigator Name
Alexandros Arvanitakis
Principal Investigator Email
Alexandros.arvanitakis@skane.se
Contact Person Name
Alexandros Arvanitakis
Site Name
Karolinska University Hospital
Department Name
ME Hematologi
Principal Investigator Name
Cecilia Karlström
Principal Investigator Email
Cecilia.karlstrom@regionstockholm.se
Contact Person Name
Cecilia Karlström

Greece

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
11
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Hematology Department
Principal Investigator Name
Antonia Syrigou
Principal Investigator Email
antonia.syrigou@gmail.com
Contact Person Name
Antonia Syrigou
Contact Person Email
antonia.syrigou@gmail.com
Site Name
Olympion General Clinic Patras P.C.
Department Name
Hematology Department
Principal Investigator Name
Anargyros (Argiris) Symeonidis
Principal Investigator Email
argiris.symeonidis@yahoo.gr
Contact Person Name
Anargyros (Argiris) Symeonidis
Contact Person Email
argiris.symeonidis@yahoo.gr

Czechia

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
87
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie
Principal Investigator Name
Jaromír Gumulec
Principal Investigator Email
jaromir.gumulec@fno.cz
Contact Person Name
Jaromír Gumulec
Contact Person Email
jaromir.gumulec@fno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Hematologická klinika
Principal Investigator Name
Olga Černá
Principal Investigator Email
olga.cerna@fnkv.cz
Contact Person Name
Olga Černá
Contact Person Email
olga.cerna@fnkv.cz

Norway

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
13
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Helse Bergen HF
Department Name
Medisinsk klinikk
Principal Investigator Name
Galina Tsykunova
Principal Investigator Email
galina.tsykunova@helse-bergen.no
Contact Person Name
Galina Tsykunova
Site Name
Sykehuset Ostfold HF
Department Name
Trombose og hemostase
Principal Investigator Name
Waleed Ghanima
Principal Investigator Email
waleed.ghanima@so-hf.no
Contact Person Name
Waleed Ghanima
Contact Person Email
waleed.ghanima@so-hf.no
Site Name
Akershus University Hospital
Department Name
Medisinsk divisjon
Principal Investigator Name
Hoa Tran
Principal Investigator Email
htra@ahus.no
Contact Person Name
Hoa Tran
Contact Person Email
htra@ahus.no

France

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
32
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Médecine Interne et Immunologie, Centre de Référence des Cytopénies Auto-Immunes de l’Adulte
Principal Investigator Name
Marc MICHEL
Principal Investigator Email
marc.michel2@aphp.fr
Contact Person Name
Marc MICHEL
Contact Person Email
marc.michel2@aphp.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Internal Medecine and Clinical Immunology
Principal Investigator Name
Bernard BONNOTTE
Principal Investigator Email
bernard.bonnotte@chudijon.fr
Contact Person Name
Bernard BONNOTTE
Contact Person Email
bernard.bonnotte@chudijon.fr

Italy

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
150
Number Of Sites
11
Number Of Participants
22

Sites

Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOSD Servizio di Immunoematologia e Medicina Trasfusionale
Principal Investigator Name
Francesco Buccisano
Principal Investigator Email
francesco.buccisano@uniroma2.it
Contact Person Name
Francesco Buccisano
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Hematology U
Principal Investigator Name
Alessandra Borchiellini
Principal Investigator Email
aborchiellini@cittadellasalute.to.it
Contact Person Name
Alessandra Borchiellini
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Ematologia
Principal Investigator Name
Andrea Patriarca
Principal Investigator Email
andrea.patriarca@uniupo.it
Contact Person Name
Andrea Patriarca
Contact Person Email
andrea.patriarca@uniupo.it
Site Name
Azienda Ospedaliero-Universitaria Federico II Di Napoli
Department Name
Hematology and Bone Marrow Transplant
Principal Investigator Name
Fabrizio Pane
Principal Investigator Email
fabrizio.pane@unina.it
Contact Person Name
Fabrizio Pane
Contact Person Email
fabrizio.pane@unina.it
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
UOC Hematology – Centre for Hemorrhagic and Thrombotic Diseases (CMET)
Principal Investigator Name
Giuseppe Carli
Principal Investigator Email
g.carli@aulss8.veneto.it
Contact Person Name
Giuseppe Carli
Contact Person Email
g.carli@aulss8.veneto.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Department of Hematology, Oncology and Molecular Medicine
Principal Investigator Name
Monica Carpenedo
Principal Investigator Email
monica.carpenedo@ospedaleniguarda.it
Contact Person Name
Monica Carpenedo
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC UCO Ematologia
Principal Investigator Name
Elisa Lucchini
Principal Investigator Email
elisa.lucchini@asugi.sanita.fvg.it
Contact Person Name
Elisa Lucchini
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dipartimento Malattie Oncologiche ed Ematologiche
Principal Investigator Name
Francesca Palandri
Principal Investigator Email
francesca.palandri@unibo.it
Contact Person Name
Francesca Palandri
Contact Person Email
francesca.palandri@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Ematologia
Principal Investigator Name
Cristina Santoro
Principal Investigator Email
santoro@bce.uniroma1.it
Contact Person Name
Cristina Santoro
Contact Person Email
santoro@bce.uniroma1.it
Site Name
ARNAS Garibaldi Di Catania
Department Name
U.O.C. Ematologia
Principal Investigator Name
Ugo Consoli
Principal Investigator Email
uconsoli@arnasgaribaldi.it
Contact Person Name
Ugo Consoli
Contact Person Email
uconsoli@arnasgaribaldi.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Hematology Department
Principal Investigator Name
Filippo Achille Brioschi
Contact Person Name
Filippo Achille Brioschi

Sponsor

Primary sponsor

Full Name
Takeda Development Center Americas Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
eCOA Translations
Name
PPD Global Limited / PPD Global Ltd.
Responsibilities
Project management, monitoring/regulatory (as listed); other codes provided without textual description in source
Name
Fisher Clinical Services UK Limited / Fisher Clinical Services GmbH
Responsibilities
Packaging/labeling/procurement/distribution of ancillary medicinal products (AxMPs), labeling and related supply activities
Name
Almac Pharma Services LLC
Responsibilities
IP supply
Name
Labcorp Central Laboratory Services LP
Responsibilities
Central laboratory services

Third parties

  • {"country":"United States","full_name":"Praxis Communications LLC","duties_or_roles":"Participant recruitment and retention materials and advocacy outreach materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Electronic clinical outcome assessment services (eCOA)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Included in event UK sites were to potentially need AxMPs (other-premedications) provided.","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH (Allschwil)","duties_or_roles":"Creation and printing of booklet labels; Packaging and labeling of AxMPs (other-premedications)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH (Rheinfelden)","duties_or_roles":"Procurement of AxMPs (other-premedications) for countries in EU; Packaging and labeling of AxMPs; Distribution of AxMPs to sites in EU","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"eCOA Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Trial Master File and Clinical Trial Management Systems","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Central and specialty Laboratories samples location tracking (Biofortis duties captured under Q Squared Solutions LLC)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Cognizant Worldwide Limited","duties_or_roles":"Safety case processing, case finalization and technical support vendor","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"Procurement of ancillary supplies; Rental of equipment; Storage at local warehouse; Shipping directly to sites in Europe, Asia and/or Australia; Calibration; Returns","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Project management duties or monitoring/regulatory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Biopier Inc.","duties_or_roles":"Unblinded data outputs to the Data Monitoring Committee","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Pharma Services LLC","duties_or_roles":"IP supply","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Participant reimbursements for study visit related expenses and travel arrangements","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH (Weil Am Rhein)","duties_or_roles":"Returns/Destructions","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Mezagitamab
Active Substance
MEZAGITAMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
euMpNumber: PRD10973342; prodAuthStatus: 1 (as recorded in product dictionary)
Investigational Product Name
Placebo matching for Mezagitamab
Modality
Other
Authorisation Status
marketingAuthNumber: N/A

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