Evaluate Ofirnoflast in Adults With Very Low- to Intermediate-risk Myelodysplastic Syndromes Requiring Transfusions

Sponsor
Halia Therapeutics, Inc.
Study ID
NCT07738510
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anemia
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ofirnoflast — DRUG
    once daily.

Study Details

The primary objective of this study is to evaluate the efficacy and safety of ofirnoflast administered orally once daily in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who are transfusion-dependent and have failed one to three prior therapies, in order to identify the optimal dose for continuation into a Phase 3 study. The secondary objectives of this study are to evaluate the extended hematologic response to ofirnoflast, to assess the safety and tolerability of ofirnoflast during the dose-selection phase, and to evaluate hematologic improvement with ofirnoflast treatment.

Key Dates

First listed
Jul 31, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Ofirnoflast
    Participants receive ofirnoflast once daily, including the 5 participants enrolled in the Phase A safety lead-in cohort. Treatment continues through the 24-Week Initial Treatment Period and, for participants demonstrating clinical benefit, the Extension Period (up to an additional 24 weeks).
  • Experimental: Arm 2: Ofirnoflast
    Participants randomized to this arm in Phase B receive ofirnoflast once daily. Treatment continues through the 24-Week Initial Treatment Period and, for participants demonstrating clinical benefit, the Extension Period (up to an additional 24 weeks).

Primary Outcome Measure

Assess safety of ofirnoflast [ Time Frame: Weeks 1-24 ]

Central Contacts

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