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A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT07294365•Dizal Pharmaceuticals

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Key Dates

Start Date

January 15, 2026

Primary Completion Date

July 1, 2027

Completion Date

December 1, 2027

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Immune Thrombocytopenia (ITP)

Interventions

DZD8586 dose level 1

DRUG

DZD8586 dose level 2

DRUG

DZD8586 dose level 3

DRUG

Contacts

Cong Wei

CONTACT

021-61095755 Cong.Wei@dizalpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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