A Study to Evaluate Ofirnoflast in Adults With Very Low- to Intermediate-risk Myelodysplastic Syndromes Requiring Red Blood Cell Transfusions

StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoints removed 4 → 2 primary endpoints
See other at-risk trials from Halia Therapeutics, Inc.

Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Enrollment increased: 50 → 70 participants
    • Trial arms changed: 2 → 6
    • Start date: Oct 2026 to Nov 2026
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 4 to 6
    • Study description shortened, about 460 words
    • Study title expanded, about 6 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The primary objective of this study is to two part. First, dose selection for dose optimization based on safety of ofirnoflast. Second, to evaluate the efficacy of ofirnoflast administered in the study population. The secondary objectives of this study are to evaluate the extended hematologic response to ofirnoflast, to assess the safety and tolerability of ofirnoflast during dose optimization, and to evaluate hematologic improvement with ofirnoflast treatment.
Trial Details
NCT Number NCT07738510
Lead Sponsor Halia Therapeutics, Inc.
Collaborators: Parexel
Conditions
(from sponsor)		 Myelodysplastic Syndromes, Anemia
Related terms Anemia, Myelodysplastic Syndromes
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov