NCT06186804

A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)

A Multicenter, Single-arm, Open-label, Phase II Clinical Study. This Study Consisting of Part A and Part B to Evaluate the Efficacy and Safety of ABSK021 (Pimicotinib) in Patients With Chronic Graft Versus Host Disease

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single arm, open label phase II clinical study in China. This study will evaluate the efficacy and safety of ABSK021 (Pimicotinib) in the treatment of patients with cGvHD who failed first-line therapy.

Detailed description

This is a phase II, open-label study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical benefit of ABSK021 in patients with hormone refractory or relapsed cGvHD. This study consisted of Part A and Part B, all cGvHD patients in this study will receive continuous oral treatment with ABSK021 once a day (QD) in a 28-day cycle, complete the core treatment period and extended treatment period, and receive regular follow-up until the termination of treatment is determined.

Conditions

• cGvHD

Interventions

Type	Name	Description
DRUG	ABSK021	Patients in each phase and dose group will receive continuous treatment with oral administration once a day for 28 days/cycle until conditions for treatment termination are met.

Timeline

• Start date: 2023-05-30
• Primary completion: 2026-10-30
• Completion: 2026-12-30
• First posted: 2024-01-02
• Last updated: 2024-08-12

Locations

14 sites across 1 country: China