drugset / Trial / NCT06468033

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

NCT06468033

Phase 3 Recruiting 150 enrolled PharmaEssentia
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-07-18
Primary completion
2027-09-30
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropeginterferon alfa-2b Protein / enzyme biologic 500 ug Subcutaneous

Indications