This is a Phase 2, open-label, randomized, multicenter study to assess the efficacy and safety of DZD8586 in patients with primary immune thrombocytopenia (ITP). The target population of this study is patients with primary ITP who had failed to respond or relapsed after receiving at least one standard therapy. Participants who meet the inclusion criteria and do not meet the exclusion criteria will be randomized to different dose groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
DZD8586 will be administered orally in a 28-day cycle.
DZD8586 will be administered orally in a 28-day cycle.
DZD8586 will be administered orally in a 28-day cycle.
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGOverall response rate (4 weeks)
The proportion of patients with platelet counts ≥ 50 × 10⁹/L on 2 consecutive visits (with an interval of at least 7 days) within 4 weeks.
Time frame: within 4 weeks
Incidence and severity of Adverse Events (AEs)
Safety profiles, for example, adverse events (AEs), serious adverse events (SAEs), ≥ Grade 3 AEs, etc., per Common Terminology Criteria in Adverse Events (CTCAE).
Time frame: 30 days after the last dose
Overall response rate (12 weeks)
The proportion of patients with platelet counts ≥ 50 × 10⁹/L on 2 consecutive visits (with an interval of at least 7 days) within 12 weeks.
Time frame: within 12 weeks
Durable response rate
The proportion of patients with platelet counts ≥ 50 × 10⁹/L on at least four of six visits between weeks 14 and 24.
Time frame: within 24 weeks
Time to response
Time to first platelet counts ≥ 50 × 10⁹/L.
Time frame: within 24 weeks
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