NCT06468033 P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
| NCT ID | NCT06468033 |
| Status | Active, Not Recruiting |
| Phase | Phase 3 |
| Sponsor | PharmaEssentia |
| Condition | Primary Myelofibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-07-18 |
| Primary Completion | 2027-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2025-07-18 with a primary completion date of 2027-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged ≥18 years at the time of signing the informed consent form; 2. Patients with pre-fibrotic/early PMF (Pre-PMF) or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS plus, diagnosed according to WHO 2016 or 2022 classification; 3. 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; 4. Hgb ≥10.0 g/dL at screening; 5. Neutrophil count ≥1.0 × 10\^9/L at screening; 6. Creatinine clearance rate ≥30 mL/min at screening (according to the Cockcroft-Gault formula); 7. 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; 8. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study. Exclusion Criteria: 1. Any known contraindications to interferon α or hypersensitivity to interferon α; 2. Patients with prior interferon therapy having poor tolerability or lack of efficacy to the previous interferon therapy per investigator\'s judgement; 3. Patients with an ongoing cytoreduction (e.g., HU or IFN-α) at the time of screening if, in the Investigator's opinion, randomizing them into the placebo arm will lead to immediate rebound increase of peripheral blood counts and thus may jeopardize their health status; 4. With severe or serious diseases that, in the Investigator's opinion, may affect the patient's participation in this study; 5. History of major organ transplantation; 6. Pregnant or breastfeeding women; 7. Patients with any other diseases that will affect the study results or may weaken the compliance to protocol per the Investigator's judgment; 8. Use any investigational drug \<4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug. 9. Eligible for JAK inhibitor therapy at screening.
Contact & Investigator
Toshiaki Sato, MD/PhD
STUDY DIRECTOR
PharmaEssentia JP
Frequently Asked Questions
Who can join the NCT06468033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Myelofibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06468033 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT06468033 currently recruiting?
NCT06468033 is currently listed as "Active, Not Recruiting" and is not actively enrolling. Check ClinicalTrials.gov for the latest status updates.
Where is the NCT06468033 trial being conducted?
This trial is being conducted at Charlotte, United States, Chūō, Japan.
Who is sponsoring the NCT06468033 clinical trial?
NCT06468033 is sponsored by PharmaEssentia. The principal investigator is Toshiaki Sato, MD/PhD at PharmaEssentia JP. The trial plans to enroll 160 participants.