A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

NCT05481151 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: ECLIPSE PV / A22-203
• Study Type: interventional
• Target: 111
• Locations: 2 countries
• Sites: 23

Brief Summary

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV

Conditions

Polycythemia Vera

Keywords

Polycythemia Vera; Essential Thrombocythemia; P1101; Ropeginterferonalfa-2b-njft; Polycythemia; Vera; PharmaEssentia; Besremi; Ropeg

Outcome Measures

Primary Outcomes (1)

• Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24.

  CHR is defined as hematocrit (HCT) \<45%, white blood cell (WBC) count \<10 × 10\^9/L, platelets (PLT) ≤400 × 10\^9/L in the absence of phlebotomy in the previous 12 weeks.

  24 weeks

Study Arms (2)

P1101 250-350-500mcg

EXPERIMENTAL

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

Drug: P1101 (Ropeginterferon alfa-2b-njft)

Ropeginterferon alfa-2b-njft

ACTIVE COMPARATOR

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

Drug: Ropeginterferon alfa-2b-njft (P1101)

Interventions

P1101 (Ropeginterferon alfa-2b-njft) DRUG

Ropeginterferon alfa-2b-njft

P1101 250-350-500mcg

Ropeginterferon alfa-2b-njft (P1101) DRUG

Ropeginterferon alfa-2b-njft

Ropeginterferon alfa-2b-njft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥18 years at the time of signing the informed consent form
• Subjects diagnosed with PV according to the 2008 or 2016 World Health Organization (WHO) criteria
• Subjects with good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin \>3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN
• Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
• Neutrophil count ≥1.5 × 10\^9/L at screening
• Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula)
• Males and females of childbearing potential, as well as all women \<2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study
• Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study

You may not qualify if:

• Any contraindications to interferon alfa or hypersensitivity to interferon alfa
• Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
• Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
• History of major organ transplantation
• Pregnant or breastfeeding women
• Subjects with any other diseases that the Investigator determines will affect the study results or may weaken the compliance to protocol, including but not limited to:
• Prior or current autoimmune thyroid disease (clinical symptoms of hyper- or hypo-thyroidism), except subjects with controlled thyroid replacement therapy, could be enrolled
• Other documented autoimmune diseases (such as hepatitis, immune thrombocytopenia \[ITP\], scleroderma, psoriasis, or any autoimmune arthritis)
• Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia, or a past history of interstitial pneumonia at screening
• Active infection with systemic manifestations (e.g., presence of bacteria, fungi, and/or human immunodeficiency virus \[HIV\] at screening, excluding hepatitis B \[HBV\] and/or hepatitis C \[HCV\] at screening)
• Evidence of severe retinopathy (e.g., cytomegalovirus \[CMV\]-induced retinitis, macular degeneration) or clinically significant eye diseases (due to diabetes or hypertension)
• History or presence of clinically relevant depression per Investigator's judgment
• Previously had suicidal attempts or has any risk for suicidal tendency at screening
• Poorly controlled diabetes defined as HbA1c \>8.0% for at least 1 year
• Active thromboembolic complications caused by PV and abdominal hemorrhage in the active phase

Sponsors & Collaborators

• PharmaEssentia: lead

Study Sites (23)

Baptist MD Anderson

Jacksonville, Florida, 32207, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

Location

University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Mercy Health

Paducah, Kentucky, 42003, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)

Bethesda, Maryland, 20817, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Astera HealthCare

East Brunswick, New Jersey, 08816, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest Baptist Medical Center

High Point, North Carolina, 27265, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 841312, United States

Location

University of Virginia - Emily Couric Cancer Center

Charlottesville, Virginia, 22903, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Juravinski Cancer Center - Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Polycythemia Vera; Thrombocythemia, Essential; Polycythemia

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders

Study Officials

• Ole Zagrijtschuk, MD, PhD

  PharmaEssentia Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: October 26, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (17); CA (6)