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Active, not recruiting Phase 3 Interventional

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

ClinicalTrials.gov ID: NCT06045689

Public ClinicalTrials.gov record NCT06045689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 29, 2026, 1:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

Study identification

NCT ID
NCT06045689
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
106 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 4, 2023
Primary completion
Sep 30, 2025
Completion
Sep 28, 2027
Last update posted
Jun 14, 2026

2023 – 2027

United States locations

U.S. sites
16
U.S. states
14
U.S. cities
16
Facility City State ZIP Site status
Local Institution - 0051 Los Alamitos California 90720-3309
Local Institution - 0033 New Haven Connecticut 06510
Local Institution - 0055 St. Petersburg Florida 33705
Local Institution - 0056 Wellington Florida 33414
Local Institution - 0020 Kansas City Kansas 66160-8500
Local Institution - 0025 Paducah Kentucky 42003-7915
Local Institution - 0011 Detroit Michigan 48202
Local Institution - 0059 St Louis Missouri 63110
Local Institution - 0058 Morristown New Jersey 07960-6136
Local Institution - 0032 New York New York 10029
Local Institution - 0054 Eugene Oregon 97401-6043
Local Institution - 0036 Pittsburgh Pennsylvania 15224
Local Institution - 0043 Amarillo Texas 79106-1781
Local Institution - 0022 Huntsville Texas 77340-4101
Local Institution - 0031 Wheeling West Virginia 26003
Local Institution - 0003 Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.

Recently updated Myelodysplastic Syndromes trials

Other public records listing Myelodysplastic Syndromes. Sorted by last update posted; newest first. Not a recommendation.

All Myelodysplastic Syndromes trials →

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06045689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 14, 2026 · Synced Jul 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06045689 live on ClinicalTrials.gov.

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