Clinical trial • Phase III • Immunology | Rare Disease

AXATILIMAB for Chronic graft-versus-host disease

Phase III trial of AXATILIMAB for Chronic graft-versus-host disease.

Overview

Trial Therapeutic Area
Immunology | Rare Disease
Trial Disease
Chronic graft-versus-host disease
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
13-09-2024
First CTIS Authorization Date
21-01-2025

Trial design

Randomised, placebo (matching) in combination with corticosteroids; corticosteroid comparators include prednisone (oral; max daily dose 1 mg/kg) and methylprednisolone (intravenous; max daily dose 1.0 mg/kg).-controlled Phase III trial in Germany, France, Netherlands and others.

Randomised
Yes
Comparator
Placebo (matching) in combination with corticosteroids; corticosteroid comparators include PREDNISONE (oral; max daily dose 1 mg/kg) and METHYLPREDNISOLONE (intravenous; max daily dose 1.0 mg/kg).
Target Sample Size
240

Eligibility

Recruits 240 paediatric patients.

Pregnancy Exclusion
Willingness to avoid pregnancy or fathering children.
Vulnerable Population
Pediatric participants (≥12 years) are included. The protocol requires ability to comprehend and willingness to sign a written ICF; a parent/guardian should provide consent for pediatric participants unable to provide consent themselves; where applicable pediatric participants should sign their own assent form. Age-specific assent and parental/guardian ICF documents are provided (assent forms referenced for 12-13y and 14-17y in the submitted documents).

Inclusion criteria

  • {"criterion_text":"- ≥ 12 years of age at the time of informed consent."}
  • {"criterion_text":"- Ability to comprehend and willingness to sign a written ICF for the study. A parent/guardian should provide consent for pediatric participants unable to provide consent themselves; in addition, where applicable, pediatric participants should sign their own assent form."}
  • {"criterion_text":"- New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy (Jagasia et al 2015). a. Moderate cGVHD: At least 1 organ (except lung) with a score of 2, ≥ 3 organs involved with a score of 1 in each organ, or lung score of 1. b. Severe cGVHD: At least 1 organ with a score of 3, or lung score of 2 or 3. Note 1: Diagnosis of cGVHD requires at least 1 diagnostic feature of cGVHD or at least 1 distinctive feature plus additional test such as biopsy, PFTs, Schirmer test, or radiographic imaging showing cGVHD in the same or another organ (see Appendix C). Participants with single-organ, genitourinary involvement or liver involvement as the only manifestation of cGVHD are not eligible. Note 2: Candidates who transition from active aGVHD to cGVHD without tapering off corticosteroids (< 0.25 mg/kg per day methylprednisolone or equivalent) and/or CNIs are eligible."}
  • {"criterion_text":"- History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible."}
  • {"criterion_text":"- KPS score ≥ 60% if 16 years of age or older; LPS score ≥ 60% if younger than 16 years of age."}
  • {"criterion_text":"- Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry."}
  • {"criterion_text":"- Willingness to avoid pregnancy or fathering children."}

Exclusion criteria

  • {"criterion_text":"- Received more than 1 prior allo-HCT. Prior autologous HCT is allowed."}
  • {"criterion_text":"- Suspected active or latent tuberculosis (as confirmed by a positive QuantiFERON® test)."}
  • {"criterion_text":"- Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible."}
  • {"criterion_text":"- Maintenance therapy for the primary hematologic disease started within 4 weeks before initiation of study treatment (Day 1) or plans to start maintenance therapy after Day 1."}
  • {"criterion_text":"- Corticosteroid therapy at doses > 0.25 mg/kg per day methylprednisolone or equivalent for any treatment other than the diagnosis of cGVHD within 7 days of randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- EFS, defined as the time from the date of randomization to the date of the first EFS event. Events are defined as addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (non-CR or non-PR by Month 6).","definition_or_measurement_approach":"EFS is measured from randomization to first EFS event; events include initiation/addition of new systemic therapy for cGVHD, death from any cause, or Day 1 if treatment failure (non-CR or non-PR by Month 6)."}

Secondary endpoints

  • {"endpoint_text":"- OR at 6 months, defined for each treatment group as CR or PR at 6 months (C7D1) in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (refined NIH response algorithm for cGVHD disease in joints and fascia [Inamoto et al 2020]).","definition_or_measurement_approach":"Objective Response (OR) at 6 months: proportion with CR or PR at Month 6 (C7D1) without new systemic therapy; response per 2014 NIH Consensus criteria and refined NIH response algorithm."}
  • {"endpoint_text":"- Response, defined as the proportion of participants with a ≥ 7-point improvement in mLSS total score at 6 months (C7D1).","definition_or_measurement_approach":"Response measured as proportion achieving ≥7-point improvement in mLSS total score at Month 6 (C7D1)."}
  • {"endpoint_text":"- EFS2, defined as the time from the date of randomization to the date of the first EFS event. Events are defined as date of progression based on best prior organ status (nadir in score level), addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (non-CR or non-PR by Month 6).","definition_or_measurement_approach":"EFS2 measured from randomization to first EFS event; events include progression based on best prior organ status (nadir), addition/initiation of new systemic therapy, death, or Day 1 if treatment failure by Month 6."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
240
Recruitment Window Months
63
Consent Approach
Informed consent requires ability to comprehend and willingness to sign a written ICF. For pediatric participants, a parent/guardian should provide consent for those unable to provide consent themselves; where applicable pediatric participants should sign their own assent form. Age-specific assent and parental/guardian ICFs are provided (assent templates for 12-13y and 14-17y, parental ICFs, and pregnancy/pregnant partner ICFs are included in the submitted documents).

Methods

  • K1_Recruitment Arrangements documents (country-specific recruitment arrangements PDFs referenced).
  • Physician pocket card (K2_Recruitment material_Physician pocket card).
  • Dr to Dr letter (K2_Recruitment material_Dr to Dr Letter / Dr to Dr Letter).
  • Physician referral letters (K2_Recruitment material_Physician referral letter).
  • General Practitioner Letter (L2_Other subject information material_General Practitioner Letter).
  • Scout Clinical email communication and Reloadable ScoutPass brochure/mailer (documents titled 'Scout Clinical_email communication' and 'Reloadable ScoutPass Brochure/Mailer').
  • Patient-facing reminder and emergency patient cards (L2_Other subject information material_Emergency Patient card; Study Reminder / Patient Reminder Card).

Geography

Total Number Of Sites
65
Total Number Of Participants
240

Germany

Earliest CTIS Part Ii Submission Date
17-12-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
471
Number Of Sites
16
Number Of Participants
36

Sites

Site Name
Universitaetsklinikum Aachen AöR
Department Name
Hematology, Oncology, Hemostaseology and Stem Cell Transplantation
Principal Investigator Name
Edgar Jost
Principal Investigator Email
ejost@ukaachen.de
Contact Person Name
Edgar Jost
Contact Person Email
ejost@ukaachen.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Internal Medicine, Hematology and Oncology
Principal Investigator Name
Lutz Mueller
Principal Investigator Email
lutz.mueller@uk-halle.de
Contact Person Name
Lutz Mueller
Contact Person Email
lutz.mueller@uk-halle.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Internal Medicine, Hematology and Oncology
Principal Investigator Name
Katharina Egger-Heidrich
Principal Investigator Email
katharina.heidrich@ukdd.de
Contact Person Name
Katharina Egger-Heidrich
Contact Person Email
katharina.heidrich@ukdd.de
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Joerg Thomas Bittenbring
Principal Investigator Email
Joerg.Thomas.Bittenbring@uks.eu
Contact Person Name
Joerg Thomas Bittenbring
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Internal Medicine
Principal Investigator Name
Eva Maria Wagner-Drouet
Principal Investigator Email
eva.wagner@unimedizin-mainz.de
Contact Person Name
Eva Maria Wagner-Drouet
Contact Person Email
eva.wagner@unimedizin-mainz.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Hematology, Oncology and Tumorimmunology
Principal Investigator Name
Olaf Penack
Principal Investigator Email
olaf.penack@charite.de
Contact Person Name
Olaf Penack
Contact Person Email
olaf.penack@charite.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Principal Investigator Name
Thomas Michael Schroeder
Principal Investigator Email
thomas.schroeder@uk-essen.de
Contact Person Name
Thomas Michael Schroeder
Contact Person Email
thomas.schroeder@uk-essen.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Medicine A/ Hemtatology and Oncology
Principal Investigator Name
Matthias Stelljes
Principal Investigator Email
stelljes@uni-muenster.de
Contact Person Name
Matthias Stelljes
Contact Person Email
stelljes@uni-muenster.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medicine, Hematology and Internal Oncology
Principal Investigator Name
Julia Winkler
Principal Investigator Email
julia.winkler@uk-erlangen.de
Contact Person Name
Julia Winkler
Contact Person Email
julia.winkler@uk-erlangen.de
Site Name
Philipps-Universitaet Marburg
Department Name
Hematology, Oncology, Ummnology,/Faculty of Medicine
Principal Investigator Name
Kristina Sohlbach
Principal Investigator Email
sohlbach@med.uni-marburg.de
Contact Person Name
Kristina Sohlbach
Contact Person Email
sohlbach@med.uni-marburg.de
Site Name
Universitaet Leipzig
Department Name
Hematology, Cell Therapy and Hemostaseology, Division Hematology and Cell Therapy
Principal Investigator Name
Georg-Nikolaus Franke
Contact Person Name
Georg-Nikolaus Franke
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik
Principal Investigator Name
Jochen Frietsch
Principal Investigator Email
Frietsch_J@ukw.de
Contact Person Name
Jochen Frietsch
Contact Person Email
Frietsch_J@ukw.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Internal Medicine II
Principal Investigator Name
Elisa Sala
Principal Investigator Email
elisa.sala@uniklinik-ulm.de
Contact Person Name
Elisa Sala
Contact Person Email
elisa.sala@uniklinik-ulm.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik
Principal Investigator Name
Catrin List
Principal Investigator Email
catrin.list@uksh.de
Contact Person Name
Catrin List
Contact Person Email
catrin.list@uksh.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik
Principal Investigator Name
Martin Schumacher
Principal Investigator Email
martin.schumacher@ukbonn.de
Contact Person Name
Martin Schumacher
Contact Person Email
martin.schumacher@ukbonn.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Haematology, Oncology and Clinical Immunology
Principal Investigator Name
Guido Kobbe
Principal Investigator Email
kobbe@med.uni-duesseldorf.de
Contact Person Name
Guido Kobbe
Contact Person Email
kobbe@med.uni-duesseldorf.de
Site Name
Universitaetsklinikum Duesseldorf AöR (additional site entry)
Department Name
Haematology, Oncology and Clinical Immunology
Principal Investigator Name
Guido Kobbe
Principal Investigator Email
kobbe@med.uni-duesseldorf.de
Contact Person Name
Guido Kobbe
Contact Person Email
kobbe@med.uni-duesseldorf.de

France

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
498
Number Of Sites
9
Number Of Participants
36

Sites

Site Name
Institut Paoli Calmettes
Department Name
Hematology
Principal Investigator Name
Raynier DEVILLIER
Principal Investigator Email
devillierr@ipc.unicancer.fr
Contact Person Name
Raynier DEVILLIER
Contact Person Email
devillierr@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Clinical Hematology
Principal Investigator Name
Amandine Charbonnier
Principal Investigator Email
charbonnier.amandine@chu-amiens.fr
Contact Person Name
Amandine Charbonnier
Site Name
Hospices Civils De Lyon
Department Name
Hematology
Principal Investigator Name
Sandrine Loron
Principal Investigator Email
sandrine.loron@chu-lyon.fr
Contact Person Name
Sandrine Loron
Contact Person Email
sandrine.loron@chu-lyon.fr
Site Name
Hopital Saint Louis
Department Name
Hematology
Principal Investigator Name
David Michonneau
Principal Investigator Email
david.michonneau@aphp.fr
Contact Person Name
David Michonneau
Contact Person Email
david.michonneau@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hematology
Principal Investigator Name
Michael Loschi
Principal Investigator Email
loschi.m@chu-nice.fr
Contact Person Name
Michael Loschi
Contact Person Email
loschi.m@chu-nice.fr
Site Name
CHRU De Nancy
Department Name
Hematology
Principal Investigator Name
Marie Thérèse Rubio
Principal Investigator Email
m.rubio@chru-nancy.fr
Contact Person Name
Marie Thérèse Rubio
Contact Person Email
m.rubio@chru-nancy.fr
Site Name
Oncopole Claudius Regaud
Department Name
Hematology
Principal Investigator Name
Anne Huynh
Principal Investigator Email
huynh.anne@iuct-oncopole.fr
Contact Person Name
Anne Huynh
Contact Person Email
huynh.anne@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology
Principal Investigator Name
Patrice Chevallier
Principal Investigator Email
patrice.chevallier@chu-nantes.fr
Contact Person Name
Patrice Chevallier
Site Name
Hopital Saint Antoine
Department Name
Clinical Hematology
Principal Investigator Name
Florent MALARD
Principal Investigator Email
florent.malard@aphp.fr
Contact Person Name
Florent MALARD
Contact Person Email
florent.malard@aphp.fr

Netherlands

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
476
Number Of Sites
2
Number Of Participants
21

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Department of Hematology
Principal Investigator Name
Man Wai Tang
Principal Investigator Email
hematology@amsterdamumc.nl
Contact Person Name
Man Wai Tang
Contact Person Email
hematology@amsterdamumc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Internal Medicine, division of Hematology
Principal Investigator Name
Gwendolyn van Gorkom
Principal Investigator Email
gwendolyn.van.gorkom@mumc.nl
Contact Person Name
Gwendolyn van Gorkom
Contact Person Email
gwendolyn.van.gorkom@mumc.nl

Denmark

Earliest CTIS Part Ii Submission Date
24-03-2025
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
371
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Rigshospitalet
Department Name
Department of Hematology
Principal Investigator Name
Brian Kornblit
Principal Investigator Email
brian.thomas.kornblit@regionh.dk
Contact Person Name
Brian Kornblit

Ireland

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
493
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
St James's Hospital
Department Name
Haematology
Principal Investigator Name
Robert Henderson
Principal Investigator Email
rhenderson@stjames.ie
Contact Person Name
Robert Henderson
Contact Person Email
rhenderson@stjames.ie

Austria

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
442
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Medical University Of Vienna
Department Name
Internal Medicine
Principal Investigator Name
Werner Rabitsch
Principal Investigator Email
werner.rabitsch@meduniwien.ac.at
Contact Person Name
Werner Rabitsch
Site Name
St. Anna Kinderspital GmbH
Department Name
Stem cell transplant day clinic and outpatient clinic
Principal Investigator Name
Anita Lawitschka
Principal Investigator Email
anita.lawitschka@stanna.at
Contact Person Name
Anita Lawitschka
Contact Person Email
anita.lawitschka@stanna.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Innere Medizin
Principal Investigator Name
Normann Steiner
Principal Investigator Email
norman.steiner@i-med.ac.at
Contact Person Name
Normann Steiner
Contact Person Email
norman.steiner@i-med.ac.at
Site Name
Medical University Of Graz
Department Name
Internal Medicine, Division of Haematology
Principal Investigator Name
Bianca Huber-Krassnitzer
Contact Person Name
Bianca Huber-Krassnitzer
Site Name
Ordensklinikum Linz GmbH
Department Name
Haematologie mit Stammzelltransplantation, Haemostaseologie und medizinische Onkologie
Principal Investigator Name
Johannes Clausen
Principal Investigator Email
johannes.clausen@ordensklinikum.at
Contact Person Name
Johannes Clausen

Spain

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
516
Number Of Sites
10
Number Of Participants
30

Sites

Site Name
Hospital Universitario Miguel Servet
Department Name
Hematology
Principal Investigator Name
Isabel Izquierdo
Principal Investigator Email
iizquierdog.iacs@aragon.es
Contact Person Name
Raynier DEVILLIER
Contact Person Email
iizquierdog.iacs@aragon.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Hematology
Principal Investigator Name
Rafael Duarte
Principal Investigator Email
rduarte.work@gmail.com
Contact Person Name
Amandine Charbonnier
Contact Person Email
rduarte.work@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Principal Investigator Name
Mi Kwon
Principal Investigator Email
mi.kwon@salud.madrid.org
Contact Person Name
Mi Kwon
Contact Person Email
mi.kwon@salud.madrid.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Guillermo Orti
Principal Investigator Email
gorti@vhio.net
Contact Person Name
Guillermo Orti
Contact Person Email
gorti@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Jose Antonio Perez
Principal Investigator Email
josea.perez.simon.sspa@juntadeandalucia.es
Contact Person Name
Jose Antonio Perez
Site Name
Hospital Universitario Donostia
Department Name
Hematology
Principal Investigator Name
Candela Ceballos
Principal Investigator Email
cceballosbolanos@gmail.com
Contact Person Name
Candela Ceballos
Contact Person Email
cceballosbolanos@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology
Principal Investigator Name
Irene Garcia
Principal Investigator Email
igarciacs@santpau.ist
Contact Person Name
Irene Garcia
Contact Person Email
igarciacs@santpau.ist
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Jaime Sanz
Principal Investigator Email
jaime.sanz@uv.es
Contact Person Name
Michael Loschi
Contact Person Email
jaime.sanz@uv.es
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Hematology
Principal Investigator Name
Melissa Torres
Principal Investigator Email
mtoroch@gobiernodecanarias.org
Contact Person Name
Melissa Torres
Contact Person Email
mtoroch@gobiernodecanarias.org
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Alberto Mussetti
Principal Investigator Email
amussetti@iconcologia.net
Contact Person Name
Alberto Mussetti
Contact Person Email
amussetti@iconcologia.net

Italy

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
486
Number Of Sites
21
Number Of Participants
45

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica di Ematologia
Principal Investigator Name
Giorgia Mancini
Principal Investigator Email
giorgia.mancini@ospedaliriuniti.marche.it
Contact Person Name
Giorgia Mancini
Site Name
Azienda Ospediera Universitaria Federico II Di Napoli
Department Name
UOC Ematologia e Trapianti di Midollo
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
Hematology
Principal Investigator Name
Anna Paola Iori
Principal Investigator Email
iori@bce.uniroma1.it
Contact Person Name
Anna Paola Iori
Contact Person Email
iori@bce.uniroma1.it
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Hematology
Principal Investigator Name
Anna Mele
Principal Investigator Email
a.mele@piafondazionepanico.it
Contact Person Name
Anna Mele
Contact Person Email
a.mele@piafondazionepanico.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
Struttura Complessa a Direzione Universitaria di Ematologia
Principal Investigator Name
Lucia Brunello
Principal Investigator Email
lucia.brunello@ospedale.al.it
Contact Person Name
Lucia Brunello
Contact Person Email
lucia.brunello@ospedale.al.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
Hematology
Principal Investigator Name
Pellegrino Musto
Principal Investigator Email
pellegrino.musto@uniba.it
Contact Person Name
Pellegrino Musto
Contact Person Email
pellegrino.musto@uniba.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Division of SC Ematologia 1
Principal Investigator Name
Nicola Polverelli
Principal Investigator Email
n.polverelli@smatteo.pv.it
Contact Person Name
Nicola Polverelli
Contact Person Email
n.polverelli@smatteo.pv.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Hematology
Principal Investigator Name
Giovanni Grillo
Principal Investigator Email
giovanni.grillo@ospedaleniguarda.it
Contact Person Name
Giovanni Grillo
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Clinical Oncohaematology and Cell Therapy Studies
Principal Investigator Name
Franco Locatelli
Principal Investigator Email
franco.locatelli@opbg.net
Contact Person Name
Franco Locatelli
Contact Person Email
franco.locatelli@opbg.net
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Unità Trapianto cellule staminali - Dipartimento Oncoematologia
Principal Investigator Name
Raffaella Cerretti
Principal Investigator Email
raffaella.cerretti@ptvonline.it
Contact Person Name
Raffaella Cerretti
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
Department of Hemato-Oncology and Radiotherapy - Transplantation and Cellular Therapies Unit
Principal Investigator Name
Maria Caterina Mico'
Principal Investigator Email
mariacaterina.mico@ospedalerc.it
Contact Person Name
Maria Caterina Mico'
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
UOSC Ematologia con Trapianto CSE
Principal Investigator Name
Alessandra Picardi
Principal Investigator Email
alessandra.picardi@aocardarelli.it
Contact Person Name
Alessandra Picardi
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Hematology and Cell Therapy
Principal Investigator Name
Emanuele Angelucci
Principal Investigator Email
emanuele.angelucci@hsanmartino.it
Contact Person Name
Emanuele Angelucci
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Medical and Surgical Sciences
Principal Investigator Name
Domenico Russo
Principal Investigator Email
domenico.russo@unibs.it
Contact Person Name
Domenico Russo
Contact Person Email
domenico.russo@unibs.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Hematology
Principal Investigator Name
Angelo Andreini
Principal Investigator Email
angelo.andreini@univr.it
Contact Person Name
Angelo Andreini
Contact Person Email
angelo.andreini@univr.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO di Ematologia e Trapianto di Midollo Osseo
Principal Investigator Name
Maria Teresa Lupo Stanghellini
Principal Investigator Email
lupostanghellini.mariateresa@hsr.it
Contact Person Name
Maria Teresa Lupo Stanghellini
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
Hematology - Transplant Bone Marrow Unit
Principal Investigator Name
Luca Castagna
Principal Investigator Email
l.castagna@villasofia.it
Contact Person Name
Luca Castagna
Contact Person Email
l.castagna@villasofia.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
Hematology Dept and Bone Marrow Transplantation
Principal Investigator Name
Angelo Michele Carella
Principal Investigator Email
am.carella@operapadrepio.it
Contact Person Name
Angelo Michele Carella
Contact Person Email
am.carella@operapadrepio.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Hematology Division and BMT Unit
Principal Investigator Name
Salvatore Leotta
Principal Investigator Email
leotta3@yahoo.it
Contact Person Name
Salvatore Leotta
Contact Person Email
leotta3@yahoo.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Hematology
Principal Investigator Name
Federico Lussana
Principal Investigator Email
flussana@asst-pg23.it
Contact Person Name
Federico Lussana
Contact Person Email
flussana@asst-pg23.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Hematology
Principal Investigator Name
Francesca Bonifazi
Principal Investigator Email
francesca.bonifazi@unibo.it
Contact Person Name
Francesca Bonifazi
Contact Person Email
francesca.bonifazi@unibo.it

Sponsor

Primary sponsor

Full Name
Incyte Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Iqvia Biotech LLC
Responsibilities
DMC management
Name
WCG Clinical Inc.
Responsibilities
WO/FE
Name
Suvoda LLC
Responsibilities
sponsor duty code 3 (responsibility listed in CTIS thirdParties)

Third parties

  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"DMC management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"Central Lab","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"WO/FE","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Axatilimab (INCA034176)
Active Substance
AXATILIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous (IV) or Subcutaneous (SC)
Route
Intravenous (IV) or Subcutaneous (SC)
Maximum Dose
0.3 mg/kg
Investigational Product Name
Placebo
Modality
Other
Investigational Product Name
PREDNISONE
Active Substance
PREDNISONE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
1 mg/kg
Investigational Product Name
METHYLPREDNISOLONE
Active Substance
METHYLPREDNISOLONE
Modality
Small molecule
Routes Of Administration
Intravenous (IV)
Route
Intravenous (IV)
Maximum Dose
1.0 mg/kg
Combination Treatment
Yes

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