Study of Elritercept for Treating Anemia in Patients with Low to Intermediate Risk Myelodysplastic Syndromes (MDS)

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What is this study about?

This clinical trial is focused on studying anemia in patients with a condition known as Myelodysplastic Syndromes (MDS). MDS is a group of disorders caused by poorly formed or dysfunctional blood cells. The trial is testing a treatment called elritercept, also known by its code name KER-050. Elritercept is a solution for injection that is being investigated to see if it can help improve anemia in patients with very low, low, or intermediate risk MDS.

The purpose of the study is to evaluate the safety and tolerability of different doses of elritercept. The study is divided into two main parts. In the first part, participants will receive increasing doses of elritercept to determine the most suitable dose for further testing. In the second part, the selected dose will be confirmed for its safety and tolerability. There is also a long-term extension phase to assess the long-term safety of elritercept in these patients.

Participants in the study will receive elritercept through subcutaneous injections, which means the medication is injected under the skin. The study will monitor participants for any side effects and how well they tolerate the treatment. The trial aims to find out if elritercept can help reduce the need for blood transfusions and improve the overall blood cell production in patients with MDS. The study will also look at how the treatment affects the progression of the disease over time.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. The participant will be required to provide informed consent, acknowledging understanding of the study and agreeing to participate.

2 part 1: dose escalation

The participant will receive KER-050, a medication administered as a solution for injection under the skin. The dose will gradually increase to evaluate safety and tolerability.

The participant will be monitored for any side effects or adverse reactions during this phase.

3 part 2: dose confirmation

The participant will continue to receive KER-050 at the dose determined to be safe in Part 1. This phase aims to confirm the safety and tolerability of the selected dose.

Regular assessments will be conducted to monitor the participant’s response to the treatment.

4 long-term extension

Participants who continue in the study will enter the long-term extension phase. This phase evaluates the long-term safety and tolerability of KER-050.

The participant will receive ongoing treatment and monitoring to assess the sustained effects of the medication.

5 end of study

The study is estimated to conclude by June 30, 2025. At the end of the study, the participant will undergo final assessments to evaluate the overall impact of the treatment.

The participant will be informed about the study results and any further steps if necessary.

Who Can Join the Study?

The patient must have a diagnosis of MDS (Myelodysplastic Syndromes) according to the WHO (World Health Organization) classification, with a risk level of very low, low, or intermediate according to the IPSS-R (International Prognostic Scoring System-Revised).
There should be less than 5% blasts (immature blood cells) in the bone marrow during the period before treatment.
The white blood cell (WBC) count in the blood should be less than 13,000 per microliter during the period before treatment.
The patient must have anemia, which means a low level of red blood cells. This can be shown by:
- For those not receiving blood transfusions, no red blood cell transfusions within 8 weeks and a hemoglobin (Hgb) level of 10.0 grams per deciliter or less during the period before treatment.
- For those receiving a low to moderate amount of blood transfusions, having received 1 to 3 units of red blood cells for a hemoglobin level of 9.0 grams per deciliter or less within 8 weeks of the period before treatment.
- For those receiving a high amount of blood transfusions, having received 4 or more units of red blood cells for a hemoglobin level of 9.0 grams per deciliter or less within 8 weeks of the period before treatment.
The patient should have an ECOG performance status of 0, 1, or 2, which is a scale used to assess how the disease affects the daily living abilities of the patient, specifically if related to anemia.
Females who can have children and sexually active males must agree to use highly effective methods of contraception to prevent pregnancy.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Marien Hospital Duesseldorf GmbH	Duesseldorf	Germany
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Universitaire De Nice	Nice	France
Mzwutiywkguncodyloxcwocnil Hcdilcxllbkoeyiq	Halle (Saale)	Germany
Ihgsybko Cplazm Dlmqkiwvcsgsfuikg	L'hospitalet De Llobregat	Spain
Pxukzg am Vymkhmsuz	Berlin	Germany
Avxsfrentp Pwwrlbwm Hoprlsrp Ds Pljlz	Paris	France
Kiojeppv Bvcequro Gfew	Bayreuth	Germany
Hxedmvjp Vqrp dnpcawcn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	31.12.2021
France	Not recruiting	31.12.2021
Germany	Not recruiting	31.12.2021
Spain	Not recruiting	31.12.2021

Trial locations

Investigated drugs:

Elritercept

KER-050 is a medication being studied for its potential to treat anemia in patients with myelodysplastic syndromes (MDS), which are a group of disorders caused by poorly formed or dysfunctional blood cells. The trial aims to assess the safety and tolerability of different doses of KER-050 to find the most effective dose for patients with very low, low, or intermediate risk MDS. The study is conducted in two parts: the first part involves testing increasing doses to determine the best dose, and the second part confirms the safety and effectiveness of the chosen dose. Additionally, there is a long-term extension phase to evaluate the ongoing safety and tolerability of KER-050 in these patients.

Investigated diseases:

Myelodysplastic syndrome

Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) – This condition is characterized by a deficiency of red blood cells in individuals with myelodysplastic syndromes, which are a group of disorders caused by poorly formed or dysfunctional blood cells. In these patients, the bone marrow does not produce enough healthy blood cells, leading to anemia. The progression of anemia in MDS can vary, with some patients experiencing mild symptoms while others may have more severe manifestations. Over time, the condition can lead to increased fatigue, weakness, and other symptoms associated with low red blood cell counts. The risk level of MDS (very low, low, or intermediate) indicates the likelihood of the disease progressing to more severe forms or transforming into acute myeloid leukemia.

Trial ID:

2023-507469-24-00

Protocol code:

KER050-MD-201

NCT ID:

NCT04419649

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Elritercept for Treating Anemia in Patients with Low to Intermediate Risk Myelodysplastic Syndromes (MDS)

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