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

January 21, 2026 updated by: Dizal Pharmaceuticals

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female participants ≥ 18 years of age.
  2. Diagnosed with persistent or chronic primary ITP, and an average of two platelet counts < 30 × 10⁹/L.
  3. Have failed at least one standard treatment for ITP (glucocorticoids and/or IVIG).
  4. Adequate bone marrow reserve and organ functions.
  5. Willing to comply with contraceptive restrictions.

Exclusion Criteria:

  1. Have evidence of secondary causes of immune thrombocytopenia.
  2. Have a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
  3. Any of previous or current treatment prohibited by protocol.
  4. Any of severe cardiac abnormalities.
  5. Active infection.
  6. Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
  7. Known allergy to DZD8586 drug excipients or other chemical analogues.
  8. Pregnant or breastfeeding female participants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DZD8586 dose level 1
Administered orally, once daily.
Drug: DZD8586 dose level 1
DZD8586 will be administered orally in a 28-day cycle.
Other Names:
  • Birelentinib
Experimental: DZD8586 dose level 2
Administered orally, once daily.
Drug: DZD8586 dose level 2
DZD8586 will be administered orally in a 28-day cycle.
Other Names:
  • Birelentinib
Experimental: DZD8586 dose level 3
Administered orally, once daily.
Drug: DZD8586 dose level 3
DZD8586 will be administered orally in a 28-day cycle.
Other Names:
  • Birelentinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (4 weeks)
Time Frame: within 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.
within 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of Adverse Events (AEs)
Time Frame: 30 days after the last dose
Safety profiles, for example, adverse events (AEs), serious adverse events (SAEs), ≥ Grade 3 AEs, etc., per Common Terminology Criteria in Adverse Events (CTCAE).
30 days after the last dose
Overall response rate (12 weeks)
Time Frame: within 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.
within 12 weeks
Durable response rate
Time Frame: within 24 weeks
The proportion of patients with platelet counts ≥ 50 × 10⁹/L on at least four of six visits between weeks 14 and 24.
within 24 weeks
Time to response
Time Frame: within 24 weeks
Time to first platelet counts ≥ 50 × 10⁹/L.
within 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dizal Pharmaceuticals

Investigators

  • Principal Investigator: Hou, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DZ2025B0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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