NCT04477850 is a Phase 2 clinical trial of Luspatercept in Myelodysplastic Syndromes, sponsored by Celgene.

Who is sponsoring NCT04477850?

NCT04477850 is sponsored by Celgene.

What drugs are being tested in NCT04477850?

Interventions in NCT04477850: Luspatercept.

What condition does NCT04477850 study?

NCT04477850 studies Myelodysplastic Syndromes.

Is NCT04477850 still recruiting?

NCT04477850 is currently status unknown. Last updated 12 October 2023.

Last reviewed 2023-10-12 · How we verify

NCT04477850

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions

Status unknown Phase 2 Last updated 12 October 2023

What this trial tests

Phase 2 trial testing Luspatercept in Myelodysplastic Syndromes in 30 participants. Status unknown.

Timeline

30 November 2020

Primary endpoint
29 September 2023

23 February 2026

Quick facts

Lead sponsor	Celgene
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	30 November 2020
Primary completion	29 September 2023
Estimated completion	23 February 2026
Sites	24 locations across China, Japan

Drugs / interventions tested

Luspatercept (LUSPATERCEPT) — full drug profile →

Conditions studied

Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Celgene — full company profile →

Who can join

20 and older, any sex, with Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) in Chinese and Japanese participants with ring sideroblasts who require Red Blood Cells (RBC) transfusions.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting TGF-β signal transduction for fibrosis and cancer therapy.
Peng D, Fu M, Wang M, Wei Y, et al · · 2022 · cited 752× · PMID 35461253 · DOI 10.1186/s12943-022-01569-x
TGF-beta signal transduction: biology, function and therapy for diseases.
Tie Y, Tang F, Peng D, Zhang Y, et al · · 2022 · cited 97× · PMID 36534225 · DOI 10.1186/s43556-022-00109-9
Targeting transforming growth factor beta signaling in metastatic osteosarcoma.
Ge R, Huang GM. · · 2023 · cited 25× · PMID 38021074 · DOI 10.1016/j.jbo.2023.100513
Bone marrow microenvironment in myelodysplastic neoplasms: insights into pathogenesis, biomarkers, and therapeutic targets.
Bahmani F, Shayanmanesh M, Safari M, Alaei A, et al · · 2025 · cited 3× · PMID 40349084 · DOI 10.1186/s12935-025-03793-z
Safety and efficacy of luspatercept in treating anemia associated with myelodysplastic syndrome with ring sideroblasts in Asian patients who require red blood cell transfusions: a phase II bridging study.
Chang C, Suzuki T, Liang Y, Tong H, et al · · 2025 · cited 3× · PMID 39991012 · DOI 10.1177/20406207251321715
Safety and efficacy of luspatercept in treating anemia associated with myelodysplastic syndrome with ring sideroblasts in Asian patients who require red blood cell transfusions: a phase II bridging study
· 2025

Verify or expand the search:

Other trials of Luspatercept

Trials testing the same drug.

NCT07463820 — A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Tre · Phase 2 · not yet recruiting
NCT07450313 — The Efficacy and Safety of Luspatercept in Improving Early Anemia After HSCT · Phase 2 · not yet recruiting
NCT07215975 — A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East · recruiting
NCT07465029 — A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in · active not recruiting
NCT07362095 — Luspatercept for the Treatment of Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation(Allo-HSCT) · Phase 1, PHASE2 · recruiting

Other recruiting trials for Myelodysplastic Syndromes

Currently open trials in the same condition.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06303193 — Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or · Phase 1, PHASE2 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting
NCT07283900 — Ascorbate in Myelodysplastic Syndrome · Phase 2 · recruiting
NCT06487247 — HEME Home Transfusion Program · NA · recruiting

Other Celgene trials

Trials by the same sponsor.

NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04477850 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 12 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04477850.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing