RecruitingPhase 1NCT07340138

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

A Phase 1b Study of Pelabresib (DAK539) add-on to Stable Dose of Ruxolitinib in Japanese Adult Patients With Myelofibrosis

Sponsor

Novartis Pharmaceuticals

Enrollment

6 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Primary myelofibrosis (PMF)Post-polycythemia Vera Myelofibrosis (Post-PV MF)Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)

Summary

This Phase 1b, multicenter, open-label study aims to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of pelabresib as add-on to ruxolitinib in Japanese patients with myelofibrosis (MF).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pelabresib and a drug called Ruxolitinib for people with post-essential thrombocythemia myelofibrosis(post-et mf), post-polycythemia vera myelofibrosis (post-pv mf), and other related conditions. The study is currently recruiting participants at 7 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.

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Interventions

DRUGPelabresib

125 mg orally once daily (QD) on Days 1-14 of each 21-day cycle

DRUGRuxolitinib

5-25 mg twice daily (BID)

Locations(7)

Novartis Investigative Site

Kamogawa, Chiba, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kamakura, Kanagawa, Japan

Novartis Investigative Site

Kurashiki, Okayama-ken, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Chūō, Yamanashi, Japan

Novartis Investigative Site

Kumamoto, Japan

View Full Details on ClinicalTrials.gov

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NCT07340138

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