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Ag-946

Clinical trials are studying Ag-946 in people with anemia due to lower-risk myelodysplastic syndromes. The trials are looking at whether Ag-946 can improve hemoglobin levels and help participants become transfusion independent. They are in Phase 2 and include adults with this blood disorder.

Table of Contents

Clinical trial overview

The available study of Ag-946 is being done in people with anemia due to lower-risk myelodysplastic syndromes, a blood disorder where the bone marrow does not make healthy blood cells well enough.[1]

This trial is designed to see whether Ag-946 can improve blood counts and reduce the need for transfusions in this patient group.[1]

Study design and phase

This is an interventional study, which means researchers give the study treatment and then measure the results.[1]

The trial is in Phase 2, a stage that looks for early signs that a treatment may work while continuing to study its effects.[1]

The study includes two parts: Phase 2a and Phase 2b. Phase 2a is meant to establish proof-of-concept, which means early evidence that the treatment may help.[1]

Phase 2b focuses on transfusion independence, which means going without blood transfusions for a planned time.[1]

Who can participate

The trial is for participants with lower-risk myelodysplastic syndromes and anemia.[1]

One part of the study focuses on participants with a low transfusion burden, meaning they need transfusions less often.[1]

The study planned enrollment is 131 participants.[1]

What the trials measure

The main hemoglobin response outcome checks whether hemoglobin rises by at least 1.5 g/dL from baseline, based on the average level from Week 8 through Week 16.[1]

Baseline means the starting point before treatment begins.[1]

The study also measures transfusion independence, which means being transfusion-free for at least 8 consecutive weeks during the core period.[1]

In Phase 2a, transfusion independence is measured in participants with low transfusion burden only.[1]

In Phase 2b, the trial measures transfusion independence for at least 8 consecutive weeks during the core period.[1]

Trial details at a glance

Trial ID Status Phase Condition Enrollment Main endpoints
NCT05490446 Authorised Phase 2 Anemia due to lower-risk myelodysplastic syndromes 131 Hemoglobin response; transfusion independence

What these trials may mean for patients

For patients, this study is trying to answer a simple question: can Ag-946 help improve anemia and reduce transfusion needs in lower-risk myelodysplastic syndromes?[1]

The trial is still an early-stage study, so it is mainly focused on learning whether the treatment shows enough benefit to support later research.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05490446Phase 2Anemia due to lower-risk myelodysplastic syndromesAuthorised131

FAQ

  • What is being studied in Ag-946 clinical trials? The trials are studying Ag-946 in people with anemia due to lower-risk myelodysplastic syndromes. The main goals are to see if it improves hemoglobin and reduces the need for blood transfusions.
  • Who can take part in these trials? The study is for participants with lower-risk myelodysplastic syndromes and anemia. Some parts of the trial focus on people with a low transfusion burden, which means they need fewer transfusions.
  • What phase are the Ag-946 trials? The study is in Phase 2. This phase usually checks early signs that a treatment may work and continues to look at safety and effectiveness.
  • What results are the trials measuring? The trials measure hemoglobin response and transfusion independence. Hemoglobin response means the blood count goes up by a set amount, and transfusion independence means going without transfusions for a period of time.
  • How many people are planned for the study? The study plans to enroll 131 participants. This gives researchers a group large enough to look at early results in lower-risk myelodysplastic syndromes.

Ongoing Clinical Trials on Ag-946

  • Study of AG-946 for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia France Germany Greece Italy +2

Glossary

  • Anemia: A condition where the blood has too little hemoglobin or too few red blood cells, which can cause tiredness and weakness.
  • Myelodysplastic syndromes (MDS): A group of bone marrow disorders where the marrow does not make healthy blood cells in the normal way.
  • Lower-risk: A term used to describe a disease group that is expected to grow more slowly or cause fewer problems than higher-risk disease.
  • Phase 2: A clinical trial stage that looks for early signs that a treatment may work and continues to study its safety and effect.
  • Interventional study: A type of trial where researchers give a treatment and then watch what happens.
  • Hemoglobin: A protein in red blood cells that carries oxygen through the body.
  • Hemoglobin response: An increase in hemoglobin that meets the study’s planned target.
  • Transfusion: A procedure in which blood is given through a vein to help replace lost or low blood cells.
  • Transfusion independence: A period when a participant does not need blood transfusions.
  • Proof-of-concept: Early evidence that a treatment may work for the condition being studied.
  • Core Period: The main part of a trial when the key study results are measured.
  • Low transfusion burden: A situation where a participant needs transfusions less often.

References