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

NCT07294365 | Recruiting Phase 2

• 1 other identifier: DZ2025B0002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Overall response rate (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 Outcomes (4)

• Incidence and severity of Adverse Events (AEs)

  30 days after the last dose

• Overall response rate (12 weeks)

  within 12 weeks

• Durable response rate

  within 24 weeks

• Time to response

  within 24 weeks

Study Arms (3)

DZD8586 dose level 1

EXPERIMENTAL

Administered orally, once daily.

Drug: DZD8586 dose level 1

DZD8586 dose level 2

EXPERIMENTAL

Administered orally, once daily.

Drug: DZD8586 dose level 2

DZD8586 dose level 3

EXPERIMENTAL

Administered orally, once daily.

Drug: DZD8586 dose level 3

Interventions

DZD8586 dose level 1 DRUG

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

Also known as: Birelentinib

DZD8586 dose level 1

DZD8586 dose level 2 DRUG

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

Also known as: Birelentinib

DZD8586 dose level 2

DZD8586 dose level 3 DRUG

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

Also known as: Birelentinib

DZD8586 dose level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

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

Study Officials

• Hou

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cong Wei

CONTACT

021-61095755; Cong.Wei@dizalpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)