P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

Sponsor
PharmaEssentia
Study ID
NCT06468033
Phase
PHASE3
Status
Recruiting
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Conditions

  • Myeloproliferative Neoplasm
  • Primary Myelofibrosis

Eligibility Criteria

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

Interventions

  • Ropeginterferon alfa-2b — BIOLOGICAL
    Pre-filled Syringe. Dosage: up to 500mcg
  • Placebo — OTHER
    Placebo is a look-alike substance with the intervention (Ropeginterferon alfa-2b) that contains no active drug.

Study Details

This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk. Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.

Key Dates

Start date
Jul 18, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

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

Arms

  • Experimental: Ropeginterferon alfa-2b (P1101)
    Ropeginterferon alfa-2b (P1101) is administrated subcutaneously (SC) every two weeks (± 3 days) until 80 weeks.
  • Placebo Comparator: Placebo control
    Placebo is administrated subcutaneously (SC) every two weeks (± 3 days) until 80 weeks.

Primary Outcome Measure

Number of Participants with Platelet count equal or less (≤) 400 × 10^9/L [ Time Frame: 80 weeks ]

Central Contacts

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