ECLIPSE PV / A22-203

Recruiting at 26 trial locations

Overseen By Jewell Jessup, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: PharmaEssentia

Must not be taking: Interferon alfa

Disqualifiers: Autoimmune diseases, Severe retinopathy, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

111 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a medication called ropeginterferon alfa-2b-njft in adults with polycythemia vera, a type of blood cancer. The goal is to see how well it works and how safe it is. The medication helps the immune system control abnormal blood cells to prevent serious health issues. Ropeginterferon alfa-2b is a new form of treatment recently shown to be safe and effective in polycythemia vera.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug P1101 (Ropeginterferon alfa-2b-njft) for treating polycythemia vera?

Research shows that Ropeginterferon alfa-2b is effective in treating polycythemia vera by reducing the JAK2 mutation, which is a key factor in the disease. It also helps maintain a good quality of life, slows disease progression, and provides long-term benefits for patients. ^{1 2 3 4 5}

Is ropeginterferon alfa-2b safe for humans?

Ropeginterferon alfa-2b has been shown to be generally safe in humans, with most side effects being mild or moderate, such as hair loss, fatigue, and flu-like symptoms. No new safety concerns were identified in studies with Japanese and European patients. ^{1 5 6 7 8}

Research Team

Ole Zagrijtschuk, MD, PhD

Principal Investigator

PharmaEssentia Corporation

Eligibility Criteria

Adults with Polycythemia Vera (PV) can join this trial if they have certain levels of hemoglobin, good liver function, adequate neutrophil counts, and sufficient kidney clearance. Women must not breastfeed and those who can bear children should use birth control during the study.

Inclusion Criteria

I agree to use birth control during and 60 days after the study, and I won't breastfeed if participating.

Written informed consent obtained from the subject or legally authorized representative, and ability for the subject to comply with the requirements of the study

My liver is functioning well according to recent tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ropeginterferon alfa-2b-njft (P1101) with dosing regimens of 250-350-500 mcg or 100 up to 500 mcg, administered via subcutaneous injection every two weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• P1101 (Ropeginterferon alfa-2b-njft)

Trial Overview The trial is testing P1101 (Ropeginterferon alfa-2b-njft), a medication for PV. It aims to see how well it works, its safety profile, and how tolerable it is for patients when taken as prescribed in the study protocol.

Participant Groups

Group I: P1101 250-350-500mcg Experimental Treatment 1 Intervention

Pre-filled Syringe, Q2W starting at 250-350-500, SC injection

Group II: Ropeginterferon alfa-2b-njft Active Control 1 Intervention

Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection

Who Is Running the Clinical Trial?

PharmaEssentia

Lead Sponsor

Trials

24

Recruited

2,800+

Findings from Research

Ropeginterferon alfa-2b is an effective treatment for polycythemia vera (PV), showing long-term hematological response and reduction in JAK2V617F allele burden, making it a promising option for patients without symptomatic splenomegaly.

This treatment offers improved tolerability and safety compared to traditional therapies, with benefits such as extended dosing intervals and a potential increase in overall survival by lowering the risk of disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pharmacokinetic evaluation of ropeginterferon alfa-2b in the treatment of polycythemia vera. Illés, Á., Pinczés, LI., Egyed, M.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A pharmacokinetic evaluation of ropeginterferon alfa-2b in the treatment of polycythemia vera. [2022]

2. Turkey pubmed.ncbi.nlm.nih.gov

Change in Polistemia Vera Treatment: Ropeginterferon Alfa-2b in Light of Current Trials. [2023]

3. Thailand pubmed.ncbi.nlm.nih.gov

Interferon apha 2b for treating patients with JAK2V617F positive polycythemia vera and essential thrombocytosis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Ropeginterferon alpha-2b targets JAK2V617F-positive polycythemia vera cells in vitro and in vivo. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

An alternative dosing strategy for ropeginterferon alfa-2b may help improve outcomes in myeloproliferative neoplasms: An overview of previous and ongoing studies with perspectives on the future. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ropeginterferon alfa-2b in Japanese patients with polycythemia vera: an open-label, single-arm, phase 2 study. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Pharmacodynamics of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects After Single Subcutaneous Administration. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

Ropeginterferon alfa-2b for the treatment of patients with polycythemia vera. [2020]