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STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS

NCT04878432 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-10-16

Study results available
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Summary

The main objective of this study was to assess the safety profile of MBG453 (sabatolimab) in combination with FDA approved hypomethylating agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral Decitabine (cedazuridine combination (INQOVI))).

Conditions

  • Myelodysplastic Syndrome (MDS)

Interventions

DRUG

MBG453

Solution for intravenous infusion

DRUG

Azacitidine

Solution for subcutaneous injection or intravenous administration

DRUG

Decitabine

Solution for intravenous administration

DRUG

INQOVI (oral decitabine)

Tablet for oral administration

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2023-10-26
Completion
2024-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878432 on ClinicalTrials.gov