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Can a modified interferon rein in early myelofibrosis?

NCT ID NCT06468033

Disease control Sponsor: PharmaEssentia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This phase 3 trial is testing whether ropeginterferon alfa-2b, a biologic drug, can help control blood cell counts and symptoms in adults with early or low-risk primary myelofibrosis, a bone marrow disorder. Participants receive either the drug or a placebo every two weeks for up to several months. The goal is to see if the drug can normalize blood counts, reduce symptom burden, and prevent progression to more advanced disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental biologic drug called ropeginterferon alfa-2b (P1101)
What this could lead to
If it works, this could offer a new treatment option to slow or control early-stage primary myelofibrosis, potentially delaying progression.
What could go wrong
This is a phase 3 trial, but the drug may not outperform placebo, and interferon-based therapies can cause flu-like symptoms, fatigue, or mood changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

160 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cellular phase chronic idiopathic myelofibrosis Myeloproliferative Disorders myeloproliferative neoplasm primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myeloproliferative neoplasm Primary myelofibrosis

Contacts and locations

Locations

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

    Bethesda, Maryland, 20817, United States

  • Bundang Seoul National University Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Catholic University of Korea Seoul - St. Mary's Hospital

    Seocho, Seoul, 06591, South Korea

  • Chang Gung Memorial Hospital - Chiayi

    Chiayi City, 613016, Taiwan

  • Chang Gung Memorial Hospital - Keelung

    Keelung, Keelung, 204, Taiwan

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, Taoyuan, 333, Taiwan

  • Cheng Hsin General Hospital

    Taipei, Taipei, 112, Taiwan

  • Chi Mei Medical Center

    Tainan, Tainan, 710402, Taiwan

  • Chi-Mei Hospital - Liouying Branch

    Tainan, Tainan, 736, Taiwan

  • China Medical University Hospital

    Taichung, Taichung, 40447, Taiwan

  • Chonnam National University - Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Duke University

    Durham, North Carolina, 27710, United States

  • Ehime University Hospital

    Matsuyama, Ehime, Japan

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangzhou, 510080, China

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 301600, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003, China

  • Hiroshima Red Cross & Atomic-Bomb Survivors Hospital

    Hiroshima, Hiroshima, Japan

  • Institute of Hematology and Oncology, Harbin The First Hospital

    Harbin, Heilongjiang, 150010, China

  • Iwate Prefectural Central Hospital

    Morioka, Iwate, Japan

  • Jewish General Hospital

    Montreal, Quebec, Canada

  • Jiangsu Provincial Hospital

    Nanjing, Jiangsu, 210024, China

  • Juntendo University Hospital

    Tokyo, Tokyo, Japan

  • Juntendo University Shizuoka Hospital

    Izunokuni, Shizuoka, Japan

  • Kameda General Hospital

    Kamogawa, Chiba, Japan

  • Kansai Medical University Hospital

    Hirakata, Osaka, Japan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, Kaohsiung, 813414, Taiwan

  • King Hussein Cancer Center

    Amman, Amman Governorate, 11941, Jordan

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, Taipei, 11259, Taiwan

  • Kyungpook National University Hospital

    Daegu, Daegu, 41944, South Korea

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mackay Memorial Hospital - Taipei

    Taipei, Taipei, 10449, Taiwan

  • Mie University Hospital

    Tsu, Mie-ken, Japan

  • National Taiwan University Hospital

    Taipei, Taipei, 100225, Taiwan

  • National University Hospital

    Singapore, Singapore, Singapore

  • Nerima Hikarigaoka Hospital

    Tokyo, Tokyo, Japan

  • Nippon Medical School Hospital

    Tokyo, Tokyo, Japan

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, Japan

  • Parkway Cancer Center

    Singapore, Singapore, Singapore

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100010, China

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

  • Queen Mary Hospital

    Hong Kong, Hong Kong, Hong Kong

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200020, China

  • Samsung Medical Center

    Seoul, Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul, 03080, South Korea

  • Severance Hospital - Shinchon

    Seoul, Seoul, 03722, South Korea

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200030, China

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, Taipei, 111, Taiwan

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, Japan

  • Singapore General Hospital

    Singapore, Singapore, Singapore

  • Southern Hospital of Southern Medical University

    Guangdong, Guangdong, 510410, China

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Taipei Municipal Wan Fang Hospital

    Taipei, Taipei, 116, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217, Taiwan

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215005, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310002, China

  • The Second Affiliated Hospital of AMU

    Chongqing, Chongqing Municipality, China

  • Tokyo Medical University Hospital

    Tokyo, Tokyo, Japan

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Union Hospital Tong Ji Medical College

    Wuhan, Hubei, China

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66103, United States

  • University of Miyazaki Hospital

    Miyazaki, Miyazaki, Japan

  • University of Washington Medical Center - Fred Hutchinson Cancer Center

    Seattle, Washington, 98195, United States

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 409-3898, Japan

  • Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Medical College of Cornell University

    New York, New York, 10021, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610093, China

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