Clinical trial • Phase III • Haematology

MEZAGITAMAB for Chronic Primary Immune Thrombocytopenia

Phase III trial of MEZAGITAMAB for Chronic Primary Immune Thrombocytopenia. open-label, none/not specified-controlled. 53 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Chronic Primary Immune Thrombocytopenia
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-07-2025
First CTIS Authorization Date
04-11-2025

Trial design

open-label, none/not specified-controlled Phase III trial in Bulgaria, Spain, Netherlands and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
53

Eligibility

Recruits 53 Vulnerable population selected. The protocol requires participants provide written informed consent via a signed and dated ICF before any trial procedures. Separate ICFs for scout/scout caregiver and pregnant partner are included in the trial documents and country-specific ICFs are provided..

Vulnerable Population
Vulnerable population selected. The protocol requires participants provide written informed consent via a signed and dated ICF before any trial procedures. Separate ICFs for scout/scout caregiver and pregnant partner are included in the trial documents and country-specific ICFs are provided.

Inclusion criteria

  • {"criterion_text":"- 1. The participant has completed TAK-079-3002 (EOT) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for “platelet response” specified for that trial during either the main study or open-label extension.\n- 2. The participant has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any trial procedures."}

Exclusion criteria

  • {"criterion_text":"- 1. Key Exclusion criteria for TAK-079-3002 participants: The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.\n- 2. Key Exclusion criteria for TAK-079-1004 participants: The participant has had any thrombotic or embolic event within 12 months before signing the ICF.\n- 3. The participant has had a splenectomy within 3 months before signing the ICF.\n- 4. The participant has received anti-CD20 treatment within 12months before screening and either of the following applies: • The last dose was received within 6 months before screening. • 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.\n- 5. The participant has received any monoclonal/polyclonal antibody for immunomodulation within 6 months before Day 1."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 01. Occurrence of TEAEs and serious TEAEs.","definition_or_measurement_approach":"Measured by recording occurrence of treatment-emergent adverse events (TEAEs) and serious TEAEs as reported during the study."}
  • {"endpoint_text":"- 02. Occurrence of TEAEs leading to permanent withdrawal of mezagitamab","definition_or_measurement_approach":"Measured by recording TEAEs that lead to permanent discontinuation of mezagitamab."}

Secondary endpoints

  • {"endpoint_text":"- 01• Duration of platelet response. • Duration between on-demand treatment courses. • Time to initiation of the first on-demand treatment course. • Occurrence of complete response. • Occurrence of ITP remission.","definition_or_measurement_approach":"Endpoints relate to platelet response duration, intervals between on‑demand treatment courses, time-to-first on‑demand course, and occurrence of complete response or remission as recorded in participant assessments and study records."}
  • {"endpoint_text":"- 02. Reduction in dose and/or frequency of concomitant ITP medications throughout the trial.","definition_or_measurement_approach":"Measured by changes in dose and/or dosing frequency of concomitant ITP medications recorded during study visits."}
  • {"endpoint_text":"- 03. Use of rescue therapy.","definition_or_measurement_approach":"Measured by recording instances and timing of rescue therapy use."}
  • {"endpoint_text":"- 04. The PK concentration at selected timepoints during and after intervention.","definition_or_measurement_approach":"Measured by PK sampling and assay of mezagitamab concentration at prespecified timepoints."}
  • {"endpoint_text":"- 05. Occurrence of ADA and NAb.","definition_or_measurement_approach":"Measured by immunogenicity assays to detect anti-drug antibodies (ADA) and neutralizing antibodies (NAb)."}

Recruitment

Planned Sample Size
53
Recruitment Window Months
38
Consent Approach
Written informed consent is required (documented via a signed and dated ICF) and any required privacy authorization must be obtained before any trial procedures. Participants are adults (≥18 years). Country- and situation-specific ICFs are provided in multiple languages (examples in the public documents include English, Bulgarian, Spanish, Dutch, Polish, Greek, German, French, Czech, Italian, Norwegian, Swedish). Separate ICFs/forms for pregnant partner, scout, and scout caregiver are available in the documents.

Methods

  • Participant recruitment and retention materials and advocacy outreach materials provided by Praxis Communications LLC (as sponsor third-party duty: Participant recruitment and retention materials and advocacy outreach materials).
  • Use of Scout Clinical for participant reimbursements for study visit related expenses and travel arrangements (Scout Clinical listed among third parties with this duty).
  • Country-specific recruitment arrangements documents (K1 recruitment arrangements files listed per country in CTIS documents).

Geography

Total Number Of Sites
41
Total Number Of Participants
107

Bulgaria

Earliest CTIS Part Ii Submission Date
02-10-2025
Latest Decision Or Authorization Date
05-11-2025
Processing Time Days
34
Number Of Sites
5
Number Of Participants
17

Sites

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
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
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
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
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

Spain

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
43
Number Of Sites
6
Number Of Participants
13

Sites

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
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Maria Eva Mingot-Castellano
Principal Investigator Email
marie.mingot.sspa@juntadeandalucia.es
Contact Person Name
Maria Eva Mingot-Castellano
Site Name
Hospital Universitario De Burgos
Department Name
Hematology
Principal Investigator Name
Tomas Gonzalez-Lopez
Principal Investigator Email
tjgonzalez@saludcastillayleon.es
Contact Person Name
Tomas Gonzalez-Lopez
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Principal Investigator Name
Cristina Pascual Izquierdo
Principal Investigator Email
cpascuali@salud.madrid.org
Contact Person Name
Cristina Pascual Izquierdo
Contact Person Email
cpascuali@salud.madrid.org
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 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

Netherlands

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
27
Number Of Sites
2
Number Of Participants
13

Sites

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
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

Poland

Earliest CTIS Part Ii Submission Date
07-10-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
62
Number Of Sites
3
Number Of Participants
12

Sites

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
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
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

Greece

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
22
Number Of Sites
2
Number Of Participants
6

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

Germany

Earliest CTIS Part Ii Submission Date
03-03-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
13
Number Of Sites
2
Number Of Participants
4

Sites

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
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

France

Earliest CTIS Part Ii Submission Date
27-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
26
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
CHU Henri Mondor, Med. Interne et Immunol., Centre d. Réf. des Cytopénies Auto-Immunes d. 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@chu-dijon.fr
Contact Person Name
Bernard BONNOTTE
Contact Person Email
bernard.bonnotte@chu-dijon.fr

Czechia

Earliest CTIS Part Ii Submission Date
19-02-2026
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
29
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

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

Sweden

Earliest CTIS Part Ii Submission Date
12-02-2026
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
15
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO Hematologi Jan Waldenströmsgata 16
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

Italy

Earliest CTIS Part Ii Submission Date
02-10-2025
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
141
Number Of Sites
11
Number Of Participants
22

Sites

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 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
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Hematology Department
Principal Investigator Name
FILIPPO ACHILLE BRIOSCHI
Contact Person Name
FILIPPO ACHILLE BRIOSCHI
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 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
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 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
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Ematologia
Principal Investigator Name
FRANCESCO BUCCISANO
Principal Investigator Email
francesco.buccisano@uniroma2.it
Contact Person Name
FRANCESCO BUCCISANO

Norway

Earliest CTIS Part Ii Submission Date
03-03-2026
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
30
Number Of Sites
3
Number Of Participants
6

Sites

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
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

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD Global Limited / PPD Global Ltd.
Responsibilities
Project management duties or monitoring/regulatory (as listed)
Name
Icon Clinical Research Limited
Responsibilities
eCOA Translations and related duties
Name
Endpoint Clinical Inc.
Responsibilities
Duties listed (code 3) - study support (as listed)
Name
WCG Clinical Inc.
Responsibilities
Clinician Reported Outcome (ITP-BAT) Rater Training

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Electronic clinical outcome assessment services (eCOA)","organisation_type":"Pharmaceutical company"}
  • {"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":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Distribution of nIMP to EMEA sites; Returns/Destructions","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"Procurement of ancillary supplies; Rental of equipment; Storage at local warehouse; Shipping directly to EMEA and APAC sites; Calibration; Returns","organisation_type":"Non-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 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":"Endpoint Clinical Inc.","duties_or_roles":"","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":"WCG Clinical Inc.","duties_or_roles":"Clinician Reported Outcome (ITP-BAT) Rater Training","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":"Veeva Systems Inc.","duties_or_roles":"Trial Master File and Clinical Trial Management System","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment (duplicate entry)","duties_or_roles":"Procurement of ancillary supplies; Rental of equipment; Storage at local warehouse; Shipping directly to EMEA and APAC sites; Calibration; Returns","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH (additional addresses)","duties_or_roles":"Procurement of nIMP for EMEA; Packaging and labeling of nIMP","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment (additional address)","duties_or_roles":"Creation and printing of booklet labels; Packaging and labeling of nIMP","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH (Swiss address)","duties_or_roles":"Creation and printing of booklet labels; Packaging and labeling of nIMP","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Mezagitamab
Active Substance
MEZAGITAMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection

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