NCT06468033

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

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: PharmaEssentia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary Myelofibrosis
• Myeloproliferative Neoplasm

Interventions

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

Timeline

• Start date: 2025-07-18
• Primary completion: 2027-09-30
• Completion: 2028-09-30
• First posted: 2024-06-21
• Last updated: 2025-08-13

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study