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A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Sponsor: Novartis Pharmaceuticals
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2026-06-08
Completion Date
2030-12-27
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Pelabresib
Pelabresib monohydrate tablets
Ruxolitinib
Ruxolitinib phosphate tablets
Placebo
Matches pelabresib
Locations (53)
Yale University School Of Medicine
New Haven, Connecticut, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Summit Medical Group Oncology
Berkeley Heights, New Jersey, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 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
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
Nanjing, Jiangsu, China
Novartis Investigative Site
Nantong, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, 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
Pune, Maharashtra, India
Novartis Investigative Site
Rishikesh, Uttarakhand, India
Novartis Investigative Site
Kolkata, West Bengal, India
Novartis Investigative Site
Delhi, India
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
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
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
Ankara, Sihhiye-Altindag, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey (Türkiye)
Novartis Investigative Site
Samsun, Turkey (Türkiye)