A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)
NCT06186804 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2024-08-12
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.
Conditions
- cGvHD
Interventions
- 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.
Sponsors & Collaborators
-
Abbisko Therapeutics 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
- 2023-05-30
- Primary Completion
- 2026-10-30
- Completion
- 2026-12-30
Countries
- China
Study Locations
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