Clinical trial • Phase III • Haematology

ELRITERCEPT for Myelodysplastic syndrome

Phase III trial of ELRITERCEPT for Myelodysplastic syndrome.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Myelodysplastic syndrome
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
23-12-2025
First CTIS Authorization Date
17-04-2026

Trial design

Randomised, open-label, epoetin alfa (erythropoietin) comparator; route: subcutaneous use; dose units: iu (international units); maximum daily dose listed in ctis data: 80,000 iu (maxdailydoseamount: 80000 iu). exact per-protocol dosing schedule not specified in the provided record.-controlled Phase III trial in Belgium, Bulgaria, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Epoetin alfa (erythropoietin) comparator; route: subcutaneous use; dose units: IU (international units); maximum daily dose listed in CTIS data: 80,000 IU (maxDailyDoseAmount: 80000 IU). Exact per-protocol dosing schedule not specified in the provided record.
Target Sample Size
190

Eligibility

Recruits 190 Only adults (≥18 years) are eligible. The protocol specifically excludes certain protected adults in France: "For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law [Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1])." Informed consent must be provided by the participant (voluntary signature of an ICF) and authorization to use protected health information/personal data is required per national/local privacy regulations. No paediatric or other vulnerable populations are selected in the trial population..

Pregnancy Exclusion
If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.
Vulnerable Population
Only adults (≥18 years) are eligible. The protocol specifically excludes certain protected adults in France: "For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law [Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1])." Informed consent must be provided by the participant (voluntary signature of an ICF) and authorization to use protected health information/personal data is required per national/local privacy regulations. No paediatric or other vulnerable populations are selected in the trial population.

Inclusion criteria

  • {"criterion_text":"- Male or female participants aged ≥18 years or older at time of signing the informed consent form (ICF).\n- Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.\n- Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System – Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected >14 days after red blood cell (RBC) transfusion or >7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.\n- Bone marrow <5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.\n- Endogenous serum erythropoietin s (EPO) level of <500 U/L. Should be results from blood samples collected >14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.\n- Participant requires RBC transfusion, as documented by the following criteria (Section 8.1.1.3). A transfusion requirement of 2 to 6 packed red blood cells (pRBCs) units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization. • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been ≤9.0 g/dL (5.6 mmol/L) with symptoms of anemia (or ≤7 g/dL [4.3 mmol/L] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria. • RBC transfusions administered when Hgb levels were >9.0 g/dL (or >7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.\n- Hgb <11.0 g/dL (6.8 mmol/L) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.\n- Eastern Cooperative Oncology Group score of 0, 1, or 2."}

Exclusion criteria

  • {"criterion_text":"- Prior therapy with any of the following: a) Epoetin alfa • At the investigator’s discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed. b) Darbepoetin. c) Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia. d) Immunomodulatory drug (IMiDs) including lenalidomide. • At the investigator’s discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization. e) Hypomethylating agent. • At the investigator’s discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization. f) Luspatercept, sotatercept, imetelstat, or elritercept. g) Immunosuppressive therapy. h) Hematopoeitic cell transplant. i) Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed. j) Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed. k) High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg/day or corticosteroid equivalent for ≥4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review. l) Investigational agent or any other agent intended for treatment MDS treatment.\n- History of solid organ or bone marrow transplantation.\n- Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.\n- Known positive for HIV, active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.\n- Body mass index ≥40 kg/m2.\n- Major surgery within 28 days before randomization.\n- New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.\n- History of allergy/anaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator’s brochure for a list of excipients) or recombination proteins.\n- History of pure red cell aplasia and/or antibody against erythropoietin (EPO).\n- Any of the following laboratory abnormalities: a) ANC <500/μL (0.5×109/L). b) Platelet count <50,000/μL (50×109/L) or ≥450,000/μL (450×109/L). c) Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN). d) Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin <3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review. e) Estimated glomerular filtration rate <30 mL/min/1.73 m2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation (Delgado et al. 2021; Kramer et al. 2022). f) Ferritin ≤50 μg/L. g) Folate ≤2.0 ng/mL. h) Vitamin B12 ≤200 pg/mL.\n- Ongoing participation in another interventional clinical trial or use of any other investigational medicinal product within five times the half-life.\n- Diagnosed to have MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.\n- Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.\n- Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention (see Section 13.1 for details).\n- Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention (see Section 13.1 for details).\n- If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.\n- For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law [Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1]).\n- Known history of diagnosis of acute myeloid leukemia (AML).\n- Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events.\n- Clinically significant cardiovascular disease defined as: a) New York Heart Association heart disease class III or IV. b) Fridericia corrected QT (QTcF) interval >500 milliseconds during screening. c) Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\n- Known ejection fraction <35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.\n- Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n- Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.\n- Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy: a) Basal or squamous cell carcinoma of the skin; b) Carcinoma in situ of the cervix; c) Carcinoma in situ of the breast; and/or d) Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants who are RBC-TI for any consecutive ≥12-week period from Cycle 1 Day 1 (C1D1) through Week 24 with concurrent mean Hgb increase ≥1.5 g/dL from baseline","definition_or_measurement_approach":"Proportion of participants achieving red blood cell transfusion independence (RBC-TI) for any consecutive period of ≥12 weeks within the first 24 weeks after C1D1, with a concurrent mean hemoglobin (Hgb) increase ≥1.5 g/dL from baseline (measured vs baseline Hgb)."}

Secondary endpoints

  • {"endpoint_text":"- Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥16-week period from C1D1 through Week 24.","definition_or_measurement_approach":"Proportion of participants achieving RBC-TI for any consecutive ≥16-week period within the 24-week assessment window from C1D1."}
  • {"endpoint_text":"- Key Secondary Endpoint: Proportion of participants who are RBC-TI for any consecutive ≥12-week period from C1D1 through Week 24.","definition_or_measurement_approach":"Proportion of participants achieving RBC-TI for any consecutive ≥12-week period within the 24-week assessment window from C1D1 (secondary scope)."}
  • {"endpoint_text":"- Key Secondary Endpoint: Proportion of participants who are RBC-TI for a consecutive 24-week period from C1D1.","definition_or_measurement_approach":"Proportion of participants achieving RBC-TI continuously for 24 weeks starting from C1D1."}
  • {"endpoint_text":"- For further details please refer to the Protocol","definition_or_measurement_approach":"Refer to protocol for additional secondary endpoints, derivations and assessment details."}

Recruitment

Planned Sample Size
190
Recruitment Window Months
96
Consent Approach
Informed consent must be voluntarily signed by the participant prior to any trial procedures; authorization to use protected health information and personal data is required in accordance with national and local privacy regulations. Only adults (≥18) provide consent; no paediatric assent procedures are applicable. Country-specific subject information and informed consent forms (SIS/ICF) are provided (multiple country-specific ICF documents listed).

Geography

Total Number Of Sites
55
Total Number Of Participants
110

Belgium

Earliest CTIS Part Ii Submission Date
31-03-2026
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
21
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology
Principal Investigator Name
Dries Deeren
Principal Investigator Email
dries.deeren@azdelta.be
Contact Person Name
Dries Deeren
Contact Person Email
dries.deeren@azdelta.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Principal Investigator Name
François Dachy
Principal Investigator Email
francois.dachy@chuuclnamur.uclouvain.be
Contact Person Name
François Dachy
Site Name
UZ Leuven
Department Name
Hematology
Principal Investigator Name
Mariëlle Beckers
Principal Investigator Email
marielle.beckers@uzleuven.be
Contact Person Name
Mariëlle Beckers
Contact Person Email
marielle.beckers@uzleuven.be

Bulgaria

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
12
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
Clinic of Clinical Hematology
Principal Investigator Name
Tanya Yankova
Principal Investigator Email
t.yankova@hematology.bg
Contact Person Name
Tanya Yankova
Contact Person Email
t.yankova@hematology.bg
Site Name
Dr. Pencho Georgiev Ambulatory For Individual Practice For Medical Aid For Clinical Hematology EOOD
Department Name
Not applicable
Principal Investigator Name
Pencho Georgiev
Principal Investigator Email
penchogeorgiev@yahoo.com
Contact Person Name
Pencho Georgiev
Contact Person Email
penchogeorgiev@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
25
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Praxis am Volkspark Berlin
Principal Investigator Name
Jan-Piet Habbel
Principal Investigator Email
jp.habbel@praxis-am-volkspark-berlin.de
Contact Person Name
Jan-Piet Habbel
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Hematology, Oncology und Tumorimmunology
Principal Investigator Name
Kathrin Rieger
Principal Investigator Email
kathrin.rieger@charite.de
Contact Person Name
Kathrin Rieger
Contact Person Email
kathrin.rieger@charite.de
Site Name
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Principal Investigator Name
Rüdiger Liersch
Principal Investigator Email
liersch@onkologie-muenster.de
Contact Person Name
Rüdiger Liersch
Contact Person Email
liersch@onkologie-muenster.de
Site Name
Klinikum Bayreuth GmbH
Department Name
Med. Klinik IV
Principal Investigator Name
Alexander Kiani
Principal Investigator Email
alexander.kiani@klinikumbayreuth.de
Contact Person Name
Alexander Kiani
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Department of Internal Medicine IV
Principal Investigator Name
Haifa Kathrin Al-Ali
Principal Investigator Email
haifa.al-ali@uk-halle.de
Contact Person Name
Haifa Kathrin Al-Ali
Contact Person Email
haifa.al-ali@uk-halle.de

Greece

Earliest CTIS Part Ii Submission Date
19-01-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
88
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
Β Propaedeutic Dpt of Internal Medicine Hematology Unit
Principal Investigator Name
Vassiliki Pappa
Principal Investigator Email
vas_pappa@yahoo.com
Contact Person Name
Vassiliki Pappa
Contact Person Email
vas_pappa@yahoo.com
Site Name
University General Hospital Of Alexandroupoli
Department Name
Department of Hematology
Principal Investigator Name
Ioannis Kotsianidis
Principal Investigator Email
jkotsian@gmail.com
Contact Person Name
Ioannis Kotsianidis
Contact Person Email
jkotsian@gmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
Department of Haematology
Principal Investigator Name
Theodoros Vassilakopoulos
Principal Investigator Email
theopvass@hotmail.com
Contact Person Name
Theodoros Vassilakopoulos
Contact Person Email
theopvass@hotmail.com
Site Name
Hippokration Hospital
Department Name
2nd Propaedeutic Dpt of Internal Medicine
Principal Investigator Name
Eleni Gavriilaki
Principal Investigator Email
elenicelli@yahoo.gr
Contact Person Name
Eleni Gavriilaki
Contact Person Email
elenicelli@yahoo.gr
Site Name
University General Hospital Of Ioannina
Department Name
Department of Haematology
Principal Investigator Name
Eleftheria Hatzimichael
Principal Investigator Email
ehatzim@uoi.gr
Contact Person Name
Eleftheria Hatzimichael
Contact Person Email
ehatzim@uoi.gr
Site Name
Laiko General Hospital Of Athens
Department Name
1st Department of Internal Medicine,
Principal Investigator Name
Panagiotis Diamantopoulos
Principal Investigator Email
pandiamantopoulos@gmail.com
Contact Person Name
Panagiotis Diamantopoulos
Contact Person Email
pandiamantopoulos@gmail.com

Ireland

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
01-05-2026
Processing Time Days
29
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Cork University Hospital
Department Name
Haematology
Principal Investigator Name
Vitaliy Mykytiv
Principal Investigator Email
Vitaliy.Mykytiv@hse.ie
Contact Person Name
Vitaliy Mykytiv
Contact Person Email
Vitaliy.Mykytiv@hse.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Haematology
Principal Investigator Name
Su Wai Maung
Principal Investigator Email
sumaung@mater.ie
Contact Person Name
Su Wai Maung
Contact Person Email
sumaung@mater.ie

Lithuania

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
6
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Oncology and Hematology Clinic
Principal Investigator Name
Milda Rudzianskiene
Principal Investigator Email
milda.rudzianskiene@kaunoklinikos.lt
Contact Person Name
Milda Rudzianskiene
Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Hematology, Oncology and Transfusion Medicine Center
Principal Investigator Name
Andrius Degulys
Principal Investigator Email
andrius.degulys@santa.lt
Contact Person Name
Andrius Degulys
Contact Person Email
andrius.degulys@santa.lt

Romania

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
33
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Hematology
Principal Investigator Name
Ionut-Ciprian Tomuleasa
Principal Investigator Email
ciprian.tomuleasa@gmail.com
Contact Person Name
Ionut-Ciprian Tomuleasa
Contact Person Email
ciprian.tomuleasa@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
5
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Helse Bergen HF
Department Name
Department of Medicine Section for Hematology
Principal Investigator Name
Astrid Olsnes
Principal Investigator Email
asmr@helse-bergen-no
Contact Person Name
Astrid Olsnes
Contact Person Email
asmr@helse-bergen-no
Site Name
Sykehuset I Vestfold HF
Department Name
Cancer and hematology centre
Principal Investigator Name
Otto Emil Nyquist
Principal Investigator Email
emil.nyquist@siv.no
Contact Person Name
Otto Emil Nyquist
Contact Person Email
emil.nyquist@siv.no
Site Name
Oslo Universitetssykehus HF
Department Name
Department of Haematology
Principal Investigator Name
Synne Torkildsen
Principal Investigator Email
xasyto@ous-hf.no
Contact Person Name
Synne Torkildsen
Contact Person Email
xasyto@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
29
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Principal Investigator Name
Wojciech Jurczak
Principal Investigator Email
wojciech.jurczak@pratia.com
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Mtz Clinical Research Powered By Pratia
Department Name
MTZ Clinical Research Powered By Pratia
Principal Investigator Name
Krzysztof Mądry
Principal Investigator Email
kmadry@wum.edu.pl
Contact Person Name
Krzysztof Mądry
Contact Person Email
kmadry@wum.edu.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
Aidport Sp. z o.o.
Department Name
Aidport sp z o.o.
Principal Investigator Name
Michał Kwiatek
Principal Investigator Email
michal.kwiatek@aidport.pl
Contact Person Name
Michał Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl
Site Name
Pratia S.A.
Department Name
Pratia Wrocław Onkologia
Principal Investigator Name
Elżbieta Kalicińska
Principal Investigator Email
biuro.onkologia.wroclaw@pratia.com
Contact Person Name
Elżbieta Kalicińska

France

Earliest CTIS Part Ii Submission Date
27-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
1
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Institut Gustave Roussy
Department Name
Hématologie
Principal Investigator Name
Christophe WILLEKENS
Principal Investigator Email
christophe.willekens@gustaveroussy.fr
Contact Person Name
Christophe WILLEKENS
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Hématologie
Principal Investigator Name
Mathieu MEUNIER
Principal Investigator Email
mmeunier2@chu-grenoble.fr
Contact Person Name
Mathieu MEUNIER
Contact Person Email
mmeunier2@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hématologie
Principal Investigator Name
Thomas CLUZEAU
Principal Investigator Email
cluzeau.t@chu-nice.fr
Contact Person Name
Thomas CLUZEAU
Contact Person Email
cluzeau.t@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie Hématologie et Thérapie Cellulaire
Principal Investigator Name
Jose Miguel TORREGROSA-DIAZ
Contact Person Name
Jose Miguel TORREGROSA-DIAZ
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hématologie Séniors
Principal Investigator Name
Lionel ADES
Principal Investigator Email
lionel.ades@aphp.fr
Contact Person Name
Lionel ADES
Contact Person Email
lionel.ades@aphp.fr

Hungary

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
28
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
University Of Debrecen
Department Name
Belgyógyászati Klinika,Hematológia
Principal Investigator Name
Árpád Illés
Principal Investigator Email
illes.arpad@med.unideb.hu
Contact Person Name
Árpád Illés
Contact Person Email
illes.arpad@med.unideb.hu
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
Hematológiai Osztály
Principal Investigator Name
Zsófia Simon
Principal Investigator Email
zsocogo@gmail.com
Contact Person Name
Zsófia Simon
Contact Person Email
zsocogo@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
07-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
23
Number Of Sites
11
Number Of Participants
19

Sites

Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Medical Oncology Department
Principal Investigator Name
Elena Crisa
Principal Investigator Email
Elena.crisa@ircc.it
Contact Person Name
Elena Crisa
Contact Person Email
Elena.crisa@ircc.it
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
Stefania Paolini
Principal Investigator Email
stefania.paolini@unibo.it
Contact Person Name
Stefania Paolini
Contact Person Email
stefania.paolini@unibo.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Department of Experimental and clinical medicine
Principal Investigator Name
Valeria Santini
Principal Investigator Email
dmsc@pec.unifi.it
Contact Person Name
Valeria Santini
Contact Person Email
dmsc@pec.unifi.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Ematologia Molecolare e Medicina di Precisione
Principal Investigator Name
Luca Malcovati
Principal Investigator Email
luca.malcovati@unipv.it
Contact Person Name
Luca Malcovati
Contact Person Email
luca.malcovati@unipv.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Hematology Dept/TRANSLATIONAL AND PRECISION MEDICINE Dept
Principal Investigator Name
Massimo Breccia
Principal Investigator Email
massimo.breccia@uniroma1.it
Contact Person Name
Massimo Breccia
Contact Person Email
massimo.breccia@uniroma1.it
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
Hematology
Principal Investigator Name
Mario Annunziata
Principal Investigator Email
mario.annunziata@aocardarelli.it
Contact Person Name
Mario Annunziata
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Biomedicina e Prevenzione
Principal Investigator Name
Maria Teresa Voso
Principal Investigator Email
voso@med.uniroma2.it
Contact Person Name
Maria Teresa Voso
Contact Person Email
voso@med.uniroma2.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncology and Hematology
Principal Investigator Name
Matteo Giovanni Della Porta
Principal Investigator Email
matteo.della_porta@hunimed.eu
Contact Person Name
Matteo Giovanni Della Porta
Contact Person Email
matteo.della_porta@hunimed.eu
Site Name
Azienda Ospedaliera di Padova
Department Name
Hematology Unit, Dept. of Medicine
Principal Investigator Name
Gianni Binotto
Principal Investigator Email
gianni.binotto@aopd.veneto.it
Contact Person Name
Gianni Binotto
Contact Person Email
gianni.binotto@aopd.veneto.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
O.U Hematology and BMT
Principal Investigator Name
Elisa Diral
Principal Investigator Email
diral.elisa@hsr.it
Contact Person Name
Elisa Diral
Contact Person Email
diral.elisa@hsr.it
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

Spain

Earliest CTIS Part Ii Submission Date
04-03-2026
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
48
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Jose Francisco Falantes Gonzalez
Principal Investigator Email
josef.falantes.sspa@juntadeandalucia.es
Contact Person Name
Jose Francisco Falantes Gonzalez
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Principal Investigator Name
Kyra Velazquez Kennedy
Principal Investigator Email
kyra.velazquez@salud.madrid.org
Contact Person Name
Kyra Velazquez Kennedy
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Elvira Mora Castera
Principal Investigator Email
mora_elv@gva.es
Contact Person Name
Elvira Mora Castera
Contact Person Email
mora_elv@gva.es
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Montserrat Arnan Sangerman
Principal Investigator Email
contactfortrialsICOLH@iconcologia.net
Contact Person Name
Montserrat Arnan Sangerman
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Hematology
Principal Investigator Name
Regina Garcia Delgado
Principal Investigator Email
reginagarciadel@yahoo.es
Contact Person Name
Regina Garcia Delgado
Contact Person Email
reginagarciadel@yahoo.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
David Valcarcel Ferreiras
Principal Investigator Email
dvalcarcel@vhio.net
Contact Person Name
David Valcarcel Ferreiras
Contact Person Email
dvalcarcel@vhio.net
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Maria Diez Campelo
Principal Investigator Email
mdiezcampelo@usal.es
Contact Person Name
Maria Diez Campelo
Contact Person Email
mdiezcampelo@usal.es

Netherlands

Earliest CTIS Part Ii Submission Date
15-04-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
2
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Hematology
Principal Investigator Name
Canan Alhan
Principal Investigator Email
c.alhan@amsterdamumc.nl
Contact Person Name
Canan Alhan
Contact Person Email
c.alhan@amsterdamumc.nl

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
codes:1,12,13,5,8 (as listed in CTIS third-party duties)
Name
PPD Development LP
Responsibilities
code:4 (as listed in CTIS third-party duties)
Name
Endpoint Clinical Inc.
Responsibilities
code:3 (as listed in CTIS third-party duties)
Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
codes:12,15 (clinical monitoring), code:8
Name
IQVIA Laboratories LLC / Iqvia Laboratories Limited
Responsibilities
laboratory services; code:4
Name
Signant Health (Management Limited / LLC)
Responsibilities
electronic patient-reported outcomes; codes:6,7

Third parties

  • {"country":"France","full_name":"Cerba","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes:1,12,13,5,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"Electronic patient-reported outcomes; codes:6,7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Biopier Inc.","duties_or_roles":"code:10; Independent statistician","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"IQVIA Laboratories LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"Electronic patient-reported outcomes; codes:6,7","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"codes:12,15 (Clinical monitoring); code:8","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"code:14; Home healthcare services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel concierge (code:15)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term sample storage; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Biopier Inc.","duties_or_roles":"code:15; Independent statistician","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Elritercept
Active Substance
ELRITERCEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
prodAuthStatus:1
Maximum Dose
5 mg/kg
Investigational Product Name
Erythropoietin (epoetin alfa)
Active Substance
EPOETIN ALFA
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
prodAuthStatus:2
Maximum Dose
80,000 IU

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