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NCT04878432 · ClinicalTrials.gov registry record · Phase 2
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT04878432: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04878432 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04878432, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study 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))).
Primary Outcome
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
Interventions
- DRUG Azacitidine
- DRUG Decitabine
- DRUG MBG453
- DRUG INQOVI (oral decitabine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2022-03-17 |
| Est. Completion | 2024-09-01 |
| Phase | Phase 2 |
Why NCT04878432 stopped before completion
NCT04878432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 4 interventions - of which Azacitidine is the first listed.
NCT04878432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04878432 about?
NCT04878432 is a clinical study titled "STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS". 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))).
What is the current status of trial NCT04878432?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2022-03-17. Estimated completion is 2024-09-01.
What interventions are being tested in trial NCT04878432?
The interventions under investigation include: Azacitidine (DRUG), Decitabine (DRUG), MBG453 (DRUG), INQOVI (oral decitabine) (DRUG).
Who is sponsoring clinical trial NCT04878432?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04878432's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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