A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis

Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Study ID
NCT07317700
Phase
PHASE3
Status
Recruiting
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Conditions

  • MF

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Flonoltinib 75mg — DRUG
    Flonoltinib 75mg，qd
  • Ruxolitinib Phosphate — DRUG
    Ruxolitinib Phosphate ,control group

Study Details

This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug/control drug until it meets the withdrawal criteria.

Key Dates

Start date
Feb 13, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2027
Completion
Mar 30, 2028

Study Design

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

Arms

  • Experimental: Experimental group
    Flonoltinib Maleate Tablets 75mg, taken orally, qd， Administer on an empty stomach
  • Active Comparator: control group
    he dosage of Ruxolitinib Phosphate Tablets should be administered orally according to the instructions, bid， Administer on an empty stomach

Primary Outcome Measure

Percentage of subjects with >=35% reduction in spleen volume from baseline [ Time Frame: Week 24 ]

Central Contacts

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