ECLIPSE PV / A22-203

Recruiting at 28 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of a new treatment called P1101 (Ropeginterferon alfa-2b-njft) for individuals with Polycythemia Vera (PV), a condition characterized by the overproduction of red blood cells. Participants will receive injections of either P1101 or a similar treatment to compare their effects. The trial suits adults diagnosed with PV who have stable liver function. The study aims to determine if P1101 can reliably manage PV symptoms. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for PV.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Ropeginterferon alfa-2b-njft, also known as P1101, is generally safe for patients with polycythemia vera (PV). Important studies, such as the PEGINVERA and PROUD/CONTINUATION-PV trials, have provided valuable safety information. These studies suggest that the treatment is usually well-tolerated over time.

In the PEGINVERA study, 51 patients received Ropeginterferon alfa-2b as their only treatment. The results indicated that the treatment was safe for these patients, and any side effects were generally manageable. Notably, the FDA has already approved this treatment for use in PV, which supports its safety.

While no treatment is without risks, the available data suggest that P1101 is safe enough for further study and use in treating PV. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for polycythemia vera?

Unlike the standard treatments for Polycythemia Vera, which often include therapies like hydroxyurea or phlebotomy, P1101 (Ropeginterferon alfa-2b-njft) offers a unique approach. This treatment is administered via a pre-filled syringe as a subcutaneous injection every two weeks, which may lead to more convenient dosing compared to daily oral medications. What sets P1101 apart is its potential to target the disease at a molecular level, possibly offering longer-lasting control over red blood cell production. Researchers are excited about P1101 because it might provide a more effective and convenient option for managing Polycythemia Vera, with the potential for fewer side effects than traditional therapies.

What evidence suggests that P1101 might be an effective treatment for Polycythemia Vera?

Research has shown that Ropeginterferon alfa-2b-njft, also known as P1101, is highly effective for treating polycythemia vera (PV). In this trial, participants will receive either P1101 at doses of 250-350-500 mcg or Ropeginterferon alfa-2b-njft starting at 100 mcg up to 500 mcg. Studies have found that Ropeginterferon alfa-2b-njft outperforms hydroxyurea, another PV treatment. It is approved and recommended as a top choice for reducing blood cell counts in people with PV. The treatment has demonstrated lasting results in managing the disease, proving its effectiveness in controlling PV. ^{6 7 8 9 10}

Who Is on the Research Team?

Ole Zagrijtschuk, MD, PhD

Principal Investigator

PharmaEssentia Corporation

Are You a Good Fit for This Trial?

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.

My liver is functioning well according to recent tests.

Neutrophil count ≥1.5 × 109/L at screening

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/5184/529746/Treatment-Patterns-of-Ropeginterferon-Alfa-2b-Njft

Treatment Patterns of Ropeginterferon Alfa-2b-Njft in the Real ... Ropeginterferon alfa-2b-njft (ropeg) was approved for the treatment of Polycythemia Vera (PV) in US since November 2021. The National ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12054645/

A multicenter study to assess efficacy, safety, and tolerability of ... Long-term outcomes of polycythemia vera patients treated with ropeginterferon alfa-2b. Leukemia. (2022) 36:1408–11. doi: 10.1038/s41375-022 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265025002162

Real-World Evidence on Outcomes and Safety of ... Ropeginterferon alfa-2b-njft (ropegIFN) has demonstrated superior efficacy over hydroxyurea in polycythemia vera (PV); however, real-world data ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40043697/

ECLIPSE-PV: A Randomized, Multicenter Study to Assess ... Introduction: Ropeginterferon alfa-2b-njft (ropeg) was approved and recommended as a preferred cytoreductive treatment for polycythemia vera (PV) ...

5. onclive.com onclive.com/view/ropeginterferon-alfa-2b-generates-superior-efficacy-vs-anagrelide-in-high-risk-essential-thrombocythemia

Ropeginterferon Alfa-2b Generates Superior Efficacy vs ... Ropeginterferon alfa-2b showed superior efficacy over anagrelide in achieving durable responses in high-risk essential thrombocythemia patients.

6. besremihcp.com besremihcp.com/side-effects/

Safety Date for BESREMi® (ropeginterferon alfa‐2b‐njft) BESREMi demonstrated a long-term, manageable safety profile1,2. The PEGINVERA study evaluated the safety of BESREMi in patients with polycythemia vera (PV) over ...

7. ashpublications.org ashpublications.org/ashclinicalnews/news/6031/Ropeginterferon-alfa-2b-njft-Approved-for

Ropeginterferon alfa-2b-njft Approved for Polycythemia Vera This decision is based on safety data from the PEGINVERA and PROUD/CONTINUATION-PV studies and efficacy data from the PEGINVERA trial.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/761166s000lbl.pdf

BESREMi - accessdata.fda.gov The safety findings described below reflect exposure to BESREMi as monotherapy for the treatment of polycythemia vera in 51 patients in the PEGINVERA study [ ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12334515/

A pharmacovigilance study of adverse events associated ... We evaluated the safety profiles of four commonly used PV therapies—ropeginterferon alfa-2b (ropeg, on-label), peginterferon alfa-2a (peg-IFN, off-label), ...

10. mayoclinic.org mayoclinic.org/drugs-supplements/ropeginterferon-alfa-2b-njft-subcutaneous-route/description/drg-20526931

Ropeginterferon alfa-2b-njft (subcutaneous route) Ropeginterferon alfa-2b-njft injection is used to treat polycythemia vera. ... Safety and efficacy have not been established. Geriatric. Appropriate studies ...