NCT04217993

Jaktinib for the Treatment of Ruxolitinib Intolerance of Myelofibrosis

Jaktinib in Intermediate-risk and High-risk Myelofibrosis and Previously Treated With Ruxolitinib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase IIB, open-label, multicenter study evaluated the efficacy and safety of oral Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis and Previously Treated With Ruxolitinib. The experiment is divided into two parts: dose exploration and extended research.

Detailed description

dose exploration: It is planned to enroll about 6 subjects. According to the baseline value of platelet count at the time of enrollment, different doses (100mg Qd or 150mg Qd or 200mg Qd or 100mg Bid) of Jaktinib Hydrochloride Tablets will be Treated. The trial is in progress Adjust the dose according to relevant laboratory indicators. When at least one subject has a spleen volume reduction of ≥35% from the baseline, the sponsor and the investigator will jointly decide whether to enter the extended study part. Extended research: It is planned to enroll about 43 subjects, and the initial dosage of Jaktinib Hydrochloride Tablets is planned to be 100mg Bid.

Conditions

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

Interventions

Type	Name	Description
DRUG	Jaktinib hydrochloride tablets	Jaktinib hydrochloride tablets 100mg twice dose group，Jaktinib hydrochloride tablets 150mg qd dose group, Jaktinib hydrochloride tablets 200mg qd dose group and Jaktinib hydrochloride tablets 100mg qd dose group

Timeline

• Start date: 2020-01-07
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2020-01-06
• Last updated: 2023-04-20

Locations

1 site across 1 country: China