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A Study to Evaluate Safety , Efficacy and Pharmacokinetics of WJ01024 Tablets Combined With Ruxolitinib in Patients With Myelofibrosis

NCT06909136 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-30

No results posted yet for this study

Summary

This is a Phase Ib/II clinical study to evaluate the safety , efficacy and pharmacokinetics of WJ01024 tablets combined with Ruxolitinib tablets in patients with myelofibrosis.The study will be conducted in two phases: Phase 1b and Phase 2.Phase Ib is a dose extension study of WJ01024 tablets combined with ruxolitinib tablets. It is planned to recruit patients with medium to high-risk myelofibrosis accompanied by splenomegaly who have had poor response or intolerance to the previously approved JAK inhibitors for myelofibrosis. Phase II is the efficacy extension stage of WJ01024 tablets combined with ruxolitinib Tablets. It is planned to expand two groups of people. Group A will expand to recruit patients with medium-high risk of myelofibrosis accompanied by splenomegaly who have not responded well to the previously approved JAK inhibitors for myelofibrosis. Group B expanded to recruit patients with medium-high-risk myelofibrosis accompanied by splenomegaly who were intolerant after treatment with previously approved JAK inhibitors for myelofibrosis.

Conditions

  • Intermediate- and High-risk Myelofibrosis (MF) Patients With Splenomegaly

Interventions

DRUG

Ruxolitinib phosphate tablet（Jakavi,NOVARTIS,9104733)

5-20mg BID (dosage per investigator judgement,JAKi intolerable pts will receive recuded dose of RUX(≥ 5mg BID),and suboptimal JAKi response pts will receive RUX of 15-20 mg BID）

Sponsors & Collaborators

  • Suzhou Junjing BioSciences Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2027-10-31
Completion
2028-05-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909136 on ClinicalTrials.gov