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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DZD8586 dose level 1 | Experimental | Administered orally, once daily. |
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| DZD8586 dose level 2 | Experimental | Administered orally, once daily. |
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| DZD8586 dose level 3 | Experimental | Administered orally, once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DZD8586 dose level 1 | Drug | DZD8586 will be administered orally in a 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events (AEs) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong Wei | Contact | 021-61095755 | Cong.Wei@dizalpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Hou | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| DZD8586 dose level 2 | Drug | DZD8586 will be administered orally in a 28-day cycle. |
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| DZD8586 dose level 3 | Drug | DZD8586 will be administered orally in a 28-day cycle. |
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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 | 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 to first platelet counts ≥ 50 × 10⁹/L. | within 24 weeks |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |