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RECRUITING
NCT07294365
PHASE2

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

Sponsor: Dizal Pharmaceuticals

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-01-15

Completion Date

2027-12

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

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.

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China