Study of Elritercept for Treating Anemia in Adults with Low to Intermediate Risk Myelodysplastic Syndromes

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What is this study about?

This clinical trial is focused on studying a condition known as myelodysplastic syndromes (MDS), which affects the blood and bone marrow, leading to anemia that requires regular blood transfusions. The study is testing a treatment called elritercept, also known by its code name KER-050. This treatment is given as a solution for injection and is being compared to a placebo to see if it can help reduce the need for blood transfusions in adults with very low, low, or intermediate-risk MDS.

The purpose of the study is to evaluate how effective elritercept is in reducing the number of red blood cell transfusions needed by participants. The study will involve participants receiving either the treatment or a placebo, and their progress will be monitored over a period of time. The main goal is to see if participants can achieve transfusion independence, meaning they do not need transfusions for at least eight weeks during the study period.

Participants will be closely monitored for any side effects or changes in their health, including laboratory tests, vital signs, and heart function tests. The study aims to provide valuable information on the safety and effectiveness of elritercept for treating transfusion-dependent anemia in people with myelodysplastic syndromes.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, elritercept, or a placebo. A placebo is a substance that looks like the medication but does not contain the active ingredient.

The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are not influenced by expectations.

2 receiving the medication

If you are assigned to receive elritercept, it will be administered as a solution for injection under the skin, known as subcutaneous use.

The dosage, frequency, and duration of administration will be determined by the study protocol, and you will be informed of these details by the study team.

3 monitoring and assessments

Throughout the study, you will undergo regular assessments to monitor your health and the effects of the treatment. This includes blood tests, vital signs checks, and possibly electrocardiograms (ECGs) to measure heart activity.

The primary goal is to evaluate if elritercept can reduce the need for red blood cell transfusions in participants with myelodysplastic syndromes (MDS).

4 evaluating outcomes

The study will assess whether you achieve transfusion independence for at least 8 weeks from the start of the study through week 24. Transfusion independence means you do not require red blood cell transfusions during this period.

Secondary outcomes include achieving transfusion independence for 24 weeks and monitoring any side effects or adverse events that may occur during the study.

5 completion of the study

The study is expected to continue until 2032, but your participation will be for a specific duration as outlined by the study team.

Upon completion, you will receive information about the treatment you received and any relevant findings from the study.

Who Can Join the Study?

  • Must be a male or female who is at least 18 years old.
  • Must have a diagnosis of myelodysplastic syndromes (MDS), which is a group of disorders caused by poorly formed or dysfunctional blood cells. This diagnosis should be confirmed by a bone marrow test.
  • Must be dependent on blood transfusions, which means needing a certain number of red blood cell (RBC) transfusions in the 16 weeks before joining the study. This includes:
    • Receiving 4 to 7 RBC units in 16 weeks, or
    • Receiving 8 or more RBC units in 16 weeks.
    • Only transfusions for a hemoglobin level (a protein in red blood cells) of less than 10 g/dL are counted.
    • Must have had at least one transfusion in each 8-week period and at least two transfusions at least 7 days apart in the 16 weeks before joining the study.
    • Cannot have a period of 56 days in a row without needing an RBC transfusion in the 16 weeks before joining the study.
  • Must have tried and not responded to or cannot tolerate erythropoiesis-stimulating agents (ESA), which are treatments that help the body make more red blood cells, or are unlikely to respond to ESA treatment. This treatment should have been stopped at least 8 weeks before joining the study.
  • Must have less than 5% blasts in the bone marrow. Blasts are immature blood cells, and having too many can be a sign of disease.
  • Must have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a person can perform daily activities.
  • Females who can have children and sexually active males must agree to use highly effective birth control methods.

Who Cannot Join the Study?

  • Patients with other types of cancer cannot participate.
  • Patients who have had a heart attack in the last 6 months are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with severe liver disease are excluded.
  • Patients with severe kidney disease cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients who have received another investigational drug within the last 30 days cannot join.
  • Patients with a history of allergic reactions to similar drugs are excluded.
  • Patients with active infections that require treatment are not eligible.
  • Patients with a history of drug or alcohol abuse in the past year cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Mater Misericordiae University Hospital Dublin Ireland
Centre Hospitalier Universitaire De Poitiers Poitiers France
Institute Of Hematology And Blood Transfusion Prague Czechia
University Hospital Limerick Limerick Ireland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
University Hospital St Marina Varna Varna Bulgaria
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Hospital Universitario Ramon Y Cajal Madrid Spain
Tallaght University Hospital Dublin Ireland
Pratia Hematologia Sp. z o.o. Katowice Poland
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Marien Hospital Duesseldorf GmbH Duesseldorf Germany
Semmelweis University Budapest Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nice Nice France
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Hopital Beaujon Clichy France
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
Universita’ Politecnica Delle Marche Ancona Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Beaumont Hospital Dublin Ireland
Specialized Hospital For Active Treatment Of Hematological Diseases EAD Sofia Bulgaria
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
University Hospital Ostrava Ostrava Czechia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Mefxrmgtecgexboxersumphpoz Hqglusdxewsuxyks Halle (Saale) Germany
Cwbz Usgptufyon Hvfozeuv Cork Ireland
Igqbvjmp Cgqmrf Dbyuahrdrawlqdpac L'hospitalet De Llobregat Spain
Wmvaoikuezl Wcphhjejjkcufboxvlao Cezwfon Oviznyewu I Twlsmfcmmdzmu Ib Mmgnwgatnwa W Lgcvw Lodz Poland
Dkc Pqrnhk Gbovztiu Avnelioveo Fmh Igfoozgufu Pijnnvwt Flu Mphyfie Air Fgv Caqiwtoi Hiaziqnxcc Eija Plovdiv Bulgaria
Mlgssjom Mxesruh Amwiizt Pleven Bulgaria
Sp Vfordpaqtvwgjga Uznbkjaxhp Hazwoapn Dublin Ireland
Pzxwvd ar Vhzsrfywh Berlin Germany
Hhcbrzid Vzow dpdexaeq Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
17.04.2025
Czechia Czechia
Recruiting
17.04.2025
France France
Recruiting
17.04.2025
Germany Germany
Recruiting
17.04.2025
Hungary Hungary
Recruiting
17.04.2025
Ireland Ireland
Recruiting
17.04.2025
Italy Italy
Recruiting
17.04.2025
Lithuania Lithuania
Recruiting
17.04.2025
Poland Poland
Recruiting
17.04.2025
Spain Spain
Recruiting
17.04.2025
Sweden Sweden
Recruiting
17.04.2025

Trial locations

Investigated drugs:

Elritercept (KER-050) is a medication being studied for its potential to help people with a condition called myelodysplastic syndromes (MDS), which can cause anemia, a shortage of red blood cells. This medication is being tested to see if it can reduce the need for blood transfusions in adults who have MDS and are dependent on transfusions to manage their anemia. The goal is to see if Elritercept can help the body produce more red blood cells on its own, reducing the need for transfusions and improving the patient’s quality of life.

Myelodysplastic Syndromes – Myelodysplastic syndromes (MDS) are a group of disorders caused by poorly formed or dysfunctional blood cells. These syndromes occur when something goes wrong in the bone marrow, where blood cells are produced. Over time, the bone marrow becomes less effective at producing healthy blood cells, leading to a shortage of red blood cells, white blood cells, and platelets. This can result in symptoms such as fatigue, infections, and easy bruising or bleeding. As the disease progresses, the risk of developing acute myeloid leukemia (AML) may increase. MDS is considered a type of cancer and is often classified based on specific genetic changes and the number of immature blood cells present.

Trial ID:
2024-516009-22-00
Protocol code:
KER-050-D301
NCT ID:
NCT06499285
Trial Phase:
Therapeutic confirmatory (Phase III)

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