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NCT Number: NCT07294365

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

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.

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Key information

Conditions

Immune Thrombocytopenia (ITP) Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Yan Shi

CONTACT

[email protected]

+86 15206660730

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

DZD8586 dose level 1

Drug

DZD8586 will be administered orally in a 28-day cycle.

Other names: Birelentinib

DZD8586 dose level 2

Drug

DZD8586 will be administered orally in a 28-day cycle.

Other names: Birelentinib

DZD8586 dose level 3

Drug

DZD8586 will be administered orally in a 28-day cycle.

Other names: Birelentinib

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. Time to response

    Time frame: within 24 weeks

    Time to first platelet counts ≥ 50 × 10⁹/L.

Study contacts

Contact information is provided by the study sponsor or research team.

Cong Wei

CONTACT

[email protected]

021-61095755

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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