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

> **NCT04878432** · PHASE2 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 39 (actual)

## Conditions studied

- Myelodysplastic Syndrome (MDS)

## Interventions

- **DRUG:** MBG453
- **DRUG:** Azacitidine
- **DRUG:** Decitabine
- **DRUG:** INQOVI (oral decitabine)

## Key facts

- **NCT ID:** NCT04878432
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-03-17
- **Primary completion:** 2023-10-26
- **Final completion:** 2024-09-01
- **Target enrollment:** 39 (ACTUAL)
- **Why stopped:** Lack of efficacy in the program as demonstrated in the earlier CMBG453B12301 (STIMULUS MDS-2) study.
- **Last updated:** 2025-10-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04878432

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04878432, "STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04878432. Licensed CC0.

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