Clinical trial • Phase III • Haematology

ELRITERCEPT for Myelodysplastic syndrome (MDS)

Phase III trial of ELRITERCEPT for Myelodysplastic syndrome (MDS).

Overview

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

Key dates

Initial CTIS Submission Date
22-11-2024
First CTIS Authorization Date
28-03-2025

Trial design

Randomised, placebo to match ker-050 solution for injection (placebo arm); dose/schedule for placebo not specified in the record-controlled Phase III trial in Czechia, Poland, Sweden and others.

Randomised
Yes
Comparator
Placebo to match ker-050 solution for injection (placebo arm); dose/schedule for placebo not specified in the record
Target Sample Size
153
Trial Duration For Participant
336

Eligibility

Recruits 153 Vulnerable population selected. Participants must have the ability to understand the study purpose and risks and provide signed and dated informed consent and authorization to use protected health information (in accordance with national/local data protection). Only adults (≥18 years) are eligible; no assent procedures for minors are described..

Pregnancy Exclusion
33. Pregnant or lactating female
Vulnerable Population
Vulnerable population selected. Participants must have the ability to understand the study purpose and risks and provide signed and dated informed consent and authorization to use protected health information (in accordance with national/local data protection). Only adults (≥18 years) are eligible; no assent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations."}
  • {"criterion_text":"- 2. Male or female ≥ 18 years of age at the time of signing informed consent."}
  • {"criterion_text":"- 3. Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader) according to WHO 2016 classification that meets the IPSS-R classification of very low, low, or intermediate risk MDS."}
  • {"criterion_text":"- 4. Transfusion-dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either: a. LTB, defined as 4 to 7 RBC units per 16 weeks; or b. HTB, defined as ≥ 8 RBC units per 16 weeks; and c. For all participants: - Only transfusion events for a pretransfusion Hgb < 10 g/dL are counted toward eligibility; - At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥ 7 days within the 16-week period immediately preceding randomization; and No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization."}
  • {"criterion_text":"- 5. Refractory or intolerant to prior ESA treatment (discontinued ≥ 4 weeks before randomization), or unlikely to respond to ESA treatment"}
  • {"criterion_text":"- 6. Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader"}
  • {"criterion_text":"- 7. Eastern Cooperative Oncology Group performance status of 0 to 2"}
  • {"criterion_text":"- 8. Females of childbearing potential and sexually active males must agree to use adequate methods"}

Exclusion criteria

  • {"criterion_text":"- 1. Del(5q) MDS or therapy-related (secondary) MDS"}
  • {"criterion_text":"- 11.\tActive infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization."}
  • {"criterion_text":"- 12.\tHistory of or known active or chronic infection with HIV, hepatitis B virus (HBV), or 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."}
  • {"criterion_text":"- 13.\tBody mass index ≥ 40 kg/m2"}
  • {"criterion_text":"- 14.\tMajor surgery within 28 days before randomization"}
  • {"criterion_text":"- 16.\tPrior use of elritercept, luspatercept, sotatercept."}
  • {"criterion_text":"- 17.\tPrior use of hypomethylating agents (HMA), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immune-suppressive therapy given for treatment of MDS"}
  • {"criterion_text":"- 18.\tIron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed"}
  • {"criterion_text":"- 19.\tVitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without concurrent vitamin B12 or folate deficiency are allowed"}
  • {"criterion_text":"- 24.\tSerum EPO level ≥ 500 U/L"}
  • {"criterion_text":"- 25.\tPlatelet count ≥ 450 × 109/L or ≤ 25 × 109/L"}
  • {"criterion_text":"- 2. Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate)."}
  • {"criterion_text":"- 26.\tAbsolute neutrophil count ≤ 500/μL"}
  • {"criterion_text":"- 27.\tSerum aspartate aminotransferase or alanine aminotransferase ≥ 3 × the upper limit of normal"}
  • {"criterion_text":"- 28.\tTotal bilirubin ≥ 2 × ULN unless attributable to Gilbert's syndrome"}
  • {"criterion_text":"- 29.\tFerritin ≤ 50 μg/L"}
  • {"criterion_text":"- 30.\tFolate ≤ 2.0 ng/mL"}
  • {"criterion_text":"- 31.\tVitamin B12 ≤ 200 pg/mL"}
  • {"criterion_text":"- 32.\tEstimated glomerular filtration rate < 30 mL/min/1.73m2 as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation"}
  • {"criterion_text":"- 33.\tPregnant or lactating female"}
  • {"criterion_text":"- 3. Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization."}
  • {"criterion_text":"- 4. Clinically significant cardiovascular disease"}
  • {"criterion_text":"- 5.\tKnown ejection fraction < 35%, confirmed by a local echocardiogram performed during Screening, or other assessment performed echocardiogram if collected within 6 months before Screening"}
  • {"criterion_text":"- 6.\tChild-Pugh class C hepatic impairment"}
  • {"criterion_text":"- 7.\tStroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening"}
  • {"criterion_text":"- 8.\tAny known history of AML"}
  • {"criterion_text":"- 9.\tPrior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants achieving transfusion independence (TI) for ≥ 8 weeks from baseline through week 24","definition_or_measurement_approach":"Measured as the proportion of participants who achieve transfusion independence (TI) for at least 8 consecutive weeks between baseline and week 24."}

Secondary endpoints

  • {"endpoint_text":"- 1.\tProportion of participants achieving TI for ≥ 24 weeks from baseline through week 48","definition_or_measurement_approach":"Measured as the proportion of participants achieving transfusion independence for at least 24 consecutive weeks between baseline and week 48."}
  • {"endpoint_text":"- 2.\tProportion of participants with HTB achieving TI for ≥ 8 weeks from baseline through week 24","definition_or_measurement_approach":"Measured as the proportion of participants with high transfusion burden (HTB) who achieve transfusion independence for ≥ 8 weeks between baseline and week 24."}
  • {"endpoint_text":"- 3.\tIncidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)","definition_or_measurement_approach":"Incidence captured through reporting of treatment-emergent adverse events and serious adverse events during the study treatment and follow-up periods."}
  • {"endpoint_text":"- 4.\tChange from baseline in clinical laboratory values, vital signs, and electrocardiograms (ECGs)","definition_or_measurement_approach":"Assessed as change from baseline in laboratory values, vital signs, and ECG parameters at scheduled study visits."}

Recruitment

Digital Remote Recruitment
True, digital methods documented include study website, website meta copy/email share, online patient brochures and online study recruitment materials (documents: Website Meta Copy Email Share, Study Website, online Patient Brochure materials).
Planned Sample Size
153
Recruitment Window Months
83
Consent Approach
Informed consent must be signed and dated by the participant; participants must be able to understand purpose and risks and provide authorization for use of protected health information. Only adults (≥18) provide consent; multiple SIS/ICF documents and translations are provided (examples in record: English and country-specific translations including Bulgarian, Spanish, French, Polish, Hungarian, Italian, Lithuanian, Russian are present among the SIS/ICF and synopsis documents). GDPR/personal data letters and pregnancy follow-up ICFs are included in the documentation.

Methods

  • Study website / Study web page (documents: K2_Recruitment material_Study website, RENEW Study Website)
  • Patient brochure / study patient brochure (documents: K2_Patient Brochure, K2_Recruitment material Patient Brochure)
  • Patient letter / invitation letters (documents: K2_Patient Letter, K2_Recruitment material Patient Letter)
  • HCP referral letter and referral form to ask healthcare professionals to refer potential participants (documents: K2_Recruitment material_HCP Referral Letter, K2_Recruitment material_HCP Referral Form)
  • Scout / Patient study brochures (documents: SCOUT patient brochures listed)
  • Website meta copy / email share (documents: Website Meta Copy Email Share) to share study information via email channels

Geography

Total Number Of Sites
50
Total Number Of Participants
82

Czechia

Earliest CTIS Part Ii Submission Date
10-03-2025
Latest Decision Or Authorization Date
28-03-2025
Processing Time Days
18
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interní hematologická klinika
Contact Person Name
Petra Bělohlávková
Contact Person Email
petra.belohlavkova@fnhk.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Interní hematologická klinika
Contact Person Name
Olga Černá
Contact Person Email
olga.cerna@fnkv.cz
Site Name
Institute Of Hematology And Blood Transfusion
Department Name
Klinický úsek - Ambulance, JIHeP a transplantační jednotka
Contact Person Name
Markéta Šťastná-Marková
Contact Person Email
marketa.markova@uhkt.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní hematologická a onkologická klinika
Contact Person Name
Jiří Mayer
Contact Person Email
mayer.jiri@fnbrno.cz

Poland

Earliest CTIS Part Ii Submission Date
27-02-2025
Latest Decision Or Authorization Date
06-04-2025
Processing Time Days
39
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
Contact Person Name
Tadeusz Robak
Site Name
Pratia Hematologia Sp. z o.o.
Contact Person Name
Sebastian Grosicki
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku
Contact Person Name
Janusz Hałka
Contact Person Email
janusz.halka@poliklinika.net

Sweden

Earliest CTIS Part Ii Submission Date
07-03-2025
Latest Decision Or Authorization Date
28-03-2025
Processing Time Days
21
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Karolinska University Hospital
Department Name
Department of Hematology
Contact Person Name
Magnus Tobiasson
Contact Person Email
magnus.tobiasson@ki.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Hematology, Oncology and Radiation Physics
Contact Person Name
Lars Nilsson
Contact Person Email
Lars.Nilsson@skane.se

Spain

Earliest CTIS Part Ii Submission Date
04-03-2025
Latest Decision Or Authorization Date
31-03-2025
Processing Time Days
27
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Institut Catala D'oncologia
Department Name
Hematology
Contact Person Name
Montserrat Arnán Sangermán
Contact Person Email
marnan@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Contact Person Name
David Valcárcel Ferreiras
Contact Person Email
dvalcarcel@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Contact Person Name
Kyra Velázquez Kennedy
Contact Person Email
kyra.vkennedy@gmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Contact Person Name
María Díez Campelo
Contact Person Email
mdiezcampelo@usal.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Contact Person Name
Elvira Mora Castera
Contact Person Email
mora_elv@gva.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Contact Person Name
Teresa Arquero Portero
Contact Person Email
tarquero@fjd.es

Lithuania

Earliest CTIS Part Ii Submission Date
19-03-2025
Latest Decision Or Authorization Date
02-04-2025
Processing Time Days
14
Number Of Sites
2
Number Of Participants
2

Sites

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

Bulgaria

Earliest CTIS Part Ii Submission Date
27-03-2025
Latest Decision Or Authorization Date
03-04-2025
Processing Time Days
7
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
First Department of Clinical Hematology
Contact Person Name
Tanya Yankova
Contact Person Email
t.yankova@hematology.bg
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinical Hematology Clinic
Contact Person Name
Atanas Radinoff
Contact Person Email
aradinoff@hotmail.com
Site Name
Military Medical Academy
Department Name
Hematology Clinic
Contact Person Name
Viktoria Barbukova
Contact Person Email
viktoriia1982@abv.bg
Site Name
University Hospital St Marina Varna
Department Name
Clinical Hematology Clinic
Contact Person Name
Ilina Dimitrova Micheva
Contact Person Email
ilinamicheva@gmail.com
Site Name
Dr. Pencho Georgiev Ambulatory For Individual Practice For Medical Aid For Clinical Hematology EOOD
Contact Person Name
Pencho Georgiev
Contact Person Email
penchogeorgiev@yahoo.com

France

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
28-03-2025
Processing Time Days
50
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Site L'Archet, Hematology
Contact Person Name
Thomas Cluzeau
Contact Person Email
cluzeau.t@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
IUCT-Oncopole, Internal Medicine
Contact Person Name
Thibault Comont
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Saint-Louis, Hematology
Contact Person Name
Lionel Ades
Contact Person Email
lionel.ades@aphp.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Site de la Milétrie, Hematology
Contact Person Name
Jose Miguel Torregrosa-Diaz

Ireland

Earliest CTIS Part Ii Submission Date
17-02-2025
Latest Decision Or Authorization Date
07-04-2025
Processing Time Days
50
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Beaumont Hospital
Department Name
Haematology
Contact Person Name
Philip Murphy
Contact Person Email
philipmurphy@beaumont.ie
Site Name
University Hospital Limerick
Department Name
Cancer Services, Haematology Department
Contact Person Name
Cian McEllistrim
Contact Person Email
cian.mcellistrim@hse.ie
Site Name
St Vincent's University Hospital
Department Name
Haematology
Contact Person Name
Claire Andrews
Contact Person Email
claireandrews@st-vincents.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Haematology
Contact Person Name
Su Wai Maung
Contact Person Email
sumaung@mater.ie
Site Name
Cork University Hospital
Department Name
Haematology
Contact Person Name
Vitaliy Mykytiv
Contact Person Email
Vitaliy.mykytiv@hse.ie
Site Name
Tallaght University Hospital
Department Name
Haematology
Contact Person Name
Helen Enright
Contact Person Email
Helen.enright@tuh.ie

Hungary

Earliest CTIS Part Ii Submission Date
28-01-2025
Latest Decision Or Authorization Date
01-04-2025
Processing Time Days
63
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Department of Internal Medicine III, Hematology
Contact Person Name
Arpad Szomor
Contact Person Email
aszomor2@mail.fmkorhaz.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Department of Hematology
Contact Person Name
Miklos Egyed
Contact Person Email
hema@kmmk.hu
Site Name
University Of Debrecen
Department Name
Clinic of Internal Medicine, Department of Hematology
Contact Person Name
Arpad Illes
Contact Person Email
illes.arpad@med.unideb.hu
Site Name
Semmelweis University
Department Name
Department of Internal Medicine and Haematology, Division of Hematology
Contact Person Name
Zsolt Nagy
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Department of Hematology
Contact Person Name
Laszlo Rejto
Contact Person Email
lrejto@med.unideb.hu

Germany

Earliest CTIS Part Ii Submission Date
28-02-2025
Latest Decision Or Authorization Date
31-03-2025
Processing Time Days
31
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Department of Hematology, Oncology and Cell Therapy
Contact Person Name
Mirjeta Berisha
Contact Person Email
mirjeta.berisha@med.ovgu.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Hematology, Oncology and Tumorimmunology
Contact Person Name
Kathrin Rieger
Contact Person Email
kathrin.rieger@charite.de
Site Name
Marien Hospital Duesseldorf GmbH
Department Name
Clinic for Oncology, Haematology and Palliative Medicine
Contact Person Name
Aristoteles Giagounidis
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medical Clinic and Policlinic III‐Internal Medicine
Contact Person Name
Karin Mayer
Contact Person Email
karin.mayer@ukbonn.de
Site Name
Universitaet Leipzig
Department Name
Clinic and Polyclinic for Haematology, Cell Therapy, Haemostaseology and Infectiology
Contact Person Name
Dominic Brauer
Site Name
Praxis am Volkspark
Contact Person Name
Jan-Piet Habbel
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Internal Medicine IV (Haematology and Oncology)
Contact Person Name
Haifa Kathrin Al-Ali
Contact Person Email
haifa.al-ali@uk-halle.de

Italy

Earliest CTIS Part Ii Submission Date
19-12-2024
Latest Decision Or Authorization Date
01-04-2025
Processing Time Days
103
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Biomedicine and Prevention
Contact Person Name
Maria Teresa Voso
Contact Person Email
voso@med.uniroma2.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Hematology Division
Contact Person Name
Elena Crisà
Contact Person Email
elena.crisa@ircc.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Department of Hematology and Oncology
Contact Person Name
Matteo Giovanni Della Porta
Contact Person Email
matteo.della_porta@hunimed.eu
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Complex structure of Hematology
Contact Person Name
Bruno Fattizzo
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Complex structure of Hematology
Contact Person Name
Luca Malcovati
Contact Person Email
luca.malcovati@unipv.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Department of Experimental and Clinical Medicine
Contact Person Name
Valeria Santini
Contact Person Email
dmsc@pec.unifi.it

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 (U.K.) Limited
Responsibilities
SAE Reconciliation, Query Management, Document Management
Name
IQVIA Limited
Responsibilities
Medical monitoring, Vendor and TMF Management; safety reporting and SAE processing duties listed
Name
PPD, part of Thermo Fisher Scientific
Responsibilities
code: 4

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaron Cpc Inc.","duties_or_roles":"Randomization list","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Home health visits","organisation_type":"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":"Almac Clinical Services LLC","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"Study branding, website","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Medical monitoring, Vendor and TMF Management; other duties (codes: 1,12,5,8)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA for patient questionnaires","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Myonex LLC","duties_or_roles":"code: 14","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eCoA for patient questionnaires","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Cognizant Worldwide Limited","duties_or_roles":"Safety reporting for all EU countries; SAE Processing (Global)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient recruitment and retention","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"University of Leipzig","duties_or_roles":"code: 4","organisation_type":"Health care"}
  • {"country":"United States","full_name":"PPD, part of Thermo Fisher Scientific","duties_or_roles":"code: 4","organisation_type":"Industry"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"code: 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"code: 14","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
elritercept
Active Substance
ELRITERCEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
MIA(IMP) 20377
Maximum Dose
65 mg/Kg
Investigational Product Name
Placebo to match ker-050 solution for injection
Modality
Other
Authorisation Status
MIA (IMP) 20377

Related trials

Other published trials that may interest you.