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

NCT07294365 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Dizal Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Hou · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07294365 on ClinicalTrials.gov