NCT05482971

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Essential Thrombocythemia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: PharmaEssentia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia

Detailed description

PharmaEssentia is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of Essential Thrombocythemia (ET) as lack of disease modifying therapies in essential ET constitutes a serious issue in modern hematology. Ropeginterferon alfa-2b-njft (P1101) may represent an effective, well-tolerated treatment with the ability to provide a deeper response and superior control of important blood parameters with the potential to alter the course of the disease and prevent progression to post-ET myelofibrosis (MF) and/or secondary acute myeloid leukemia (sAML). Ropeginterferon alfa-2b-njft (P1101) is currently being evaluated in comparison to ANA in the ongoing global Phase 3 clinical study, SURPASS ET. Enrolled patients will receive P1101 over 13 months followed by an extension period.

Conditions

• Essential Thrombocythemia

Interventions

Type	Name	Description
DRUG	Ropeginterferon alfa-2b-njft (P1101)	Ropeginterferon alfa-2b-njft (P1101)

Timeline

• Start date: 2022-09-29
• Primary completion: 2025-05-09
• Completion: 2027-03-31
• First posted: 2022-08-01
• Last updated: 2025-08-13

Locations

34 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study