RecruitingPhase 3NCT07357727

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive

Sponsor

Novartis Pharmaceuticals

Enrollment

460 participants

Start Date

Jun 16, 2026

Study Type

INTERVENTIONAL

Conditions

Primary myelofibrosis (PMF)Post-polycythemia Vera Myelofibrosis (PPV-MF)Post-essential Thrombocythemia Myelofibrosis (PET-MF)

Summary

The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pelabresib, a drug called Placebo, and others for people with post-essential thrombocythemia myelofibrosis (pet-mf), post-polycythemia vera myelofibrosis (ppv-mf), and other related conditions. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPelabresib

Pelabresib monohydrate tablets

DRUGRuxolitinib

Ruxolitinib phosphate tablets

DRUGPlacebo

Matches pelabresib

Locations(77)

Yale University School Of Medicine

New Haven, Connecticut, United States

The Anderson Family Cancer Institute

Jupiter, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Summit Medical Group Oncology

Berkeley Heights, New Jersey, United States

New York Oncology Hematology P C

Albany, New York, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutch Cancer Research

Seattle, Washington, United States

Novartis Investigative Site

Buenos Aires, Buenos Aires F.D., Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Capital Federal, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Adelaide, South Australia, Australia

Novartis Investigative Site

Clayton, Victoria, Australia

Novartis Investigative Site

Hefei, Anhui, China

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Nantong, Jiangsu, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Jinan, Shandong, China

Novartis Investigative Site

Yantai, Shandong, China

Novartis Investigative Site

Kunming, Yunnan, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Wenzhou, Zhejiang, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Chongqing, China

Novartis Investigative Site

Fuzhou, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Shenyang, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Aurangabad, Maharashtra, India

Novartis Investigative Site

Pune, Maharashtra, India

Novartis Investigative Site

Rishikesh, Uttarakhand, India

Novartis Investigative Site

Kolkata, West Bengal, India

Novartis Investigative Site

Delhi, India

Novartis Investigative Site

Padova, PD, Italy

Novartis Investigative Site

Verona, VR, Italy

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Shiwa-Gun, Iwate, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Chūō, Yamanashi, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Miyazaki, Japan

Novartis Investigative Site

George Town, Pulau Pinang, Malaysia

Novartis Investigative Site

Kota Kinabalu, Sabah, Malaysia

Novartis Investigative Site

Kuching, Sarawak, Malaysia

Novartis Investigative Site

Johor Bahru, Malaysia

Novartis Investigative Site

Kuala Selangor, Malaysia

Novartis Investigative Site

Katowice, Poland

Novartis Investigative Site

Skorzewo, Poland

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Novartis Investigative Site

Jeonju, Jeollabuk-do, South Korea

Novartis Investigative Site

Seoul, Yangcheon Gu, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Basel, Switzerland

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Geneva, Switzerland

Novartis Investigative Site

Genolier, Switzerland

Novartis Investigative Site

Changhua, Taiwan

Novartis Investigative Site

Kaohsiung City, Taiwan

Novartis Investigative Site

Tainan, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Sihhiye-Altindag, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Turkey (Türkiye)

Novartis Investigative Site

Izmir, Turkey (Türkiye)

Novartis Investigative Site

Kocaeli, Turkey (Türkiye)

Novartis Investigative Site

Samsun, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07357727

Related Trials

A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms

NCT074698918 locations

Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis

NCT073401387 locations

Identification of MPN-specific Antigens and Anti-MPN TCRs in Myeloproliferative Neoplasm

NCT075909861 location

MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myeloproliferative Neoplasms (MPNs)

NCT073622252 locations

Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis

NCT067708421 location