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A Phase 2 Study to Evaluate DZD8586 in Adults With ITP (TAI-SHAN11)

NCT ID: NCT07294365

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Immune Thrombocytopenia (ITP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DZD8586 dose level 1

Administered orally, once daily.

Group Type EXPERIMENTAL

DZD8586 dose level 1

Intervention Type DRUG

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

DZD8586 dose level 2

Administered orally, once daily.

Group Type EXPERIMENTAL

DZD8586 dose level 2

Intervention Type DRUG

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

DZD8586 dose level 3

Administered orally, once daily.

Group Type EXPERIMENTAL

DZD8586 dose level 3

Intervention Type DRUG

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

Interventions

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DZD8586 dose level 1

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

Intervention Type DRUG

DZD8586 dose level 2

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

Intervention Type DRUG

DZD8586 dose level 3

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

Intervention Type DRUG

Other Intervention Names

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Birelentinib Birelentinib Birelentinib

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dizal Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hou

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Cong Wei

Role: CONTACT

Phone: 021-61095755

Email: [email protected]

Facility Contacts

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Yan Shi

Role: primary

Other Identifiers

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DZ2025B0002

Identifier Type: -

Identifier Source: org_study_id