Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

Phase 2 Completed 74 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).

Timeline

Start: 2012-11-28
Primary completion: 2018-04-30
Completion: 2018-04-30

Publications

Komrokji R, Garcia-Manero G, Ades L, Prebet T, Steensma DP, Jurcic JG, Sekeres MA, Berdeja J, Savona MR, Beyne-Rauzy O, Stamatoullas A, DeZern AE, Delaunay J, Borthakur G, Rifkin R, Boyd TE, Laadem A, Vo B, Zhang J, Puccio-Pick M, Attie KM, Fenaux P, List AF. Sotatercept with long-term extension for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes: a phase 2, dose-ranging trial. Lancet Haematol. 2018 Feb;5(2):e63-e72. doi: 10.1016/S2352-3026(18)30002-4. Epub 2018 Jan 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sotatercept	Protein / enzyme biologic	0.1 mg/kg	Subcutaneous
Subject	Sotatercept	Protein / enzyme biologic	0.3 mg/kg	Subcutaneous
Subject	Sotatercept	Protein / enzyme biologic	0.5 mg/kg	Subcutaneous
Subject	Sotatercept	Protein / enzyme biologic	1 mg/kg	Subcutaneous
Subject	Sotatercept	Protein / enzyme biologic	1.5 mg/kg	Subcutaneous
Subject	Sotatercept	Protein / enzyme biologic	2 mg/kg	Subcutaneous

Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

Summary

Timeline

Publications

Drugs

Indications