NCT07294365

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dizal Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	DZD8586 dose level 1	DZD8586 will be administered orally in a 28-day cycle.
DRUG	DZD8586 dose level 2	DZD8586 will be administered orally in a 28-day cycle.
DRUG	DZD8586 dose level 3	DZD8586 will be administered orally in a 28-day cycle.

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2025-12-19
• Last updated: 2026-01-22

Locations

1 site across 1 country: China