Immune Thrombocytopenia (ITP)
Conditions
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.
Interventions
DRUGDZD8586 dose level 1
DZD8586 will be administered orally in a 28-day cycle.
DRUGDZD8586 dose level 2
DZD8586 will be administered orally in a 28-day cycle.
DRUGDZD8586 dose level 3
DZD8586 will be administered orally in a 28-day cycle.
Sponsors
Dizal Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (4 weeks) | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Adverse Events (AEs) | 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). |
| Overall response rate (12 weeks) | 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. |
| Durable response rate | 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. |
| Time to response | within 24 weeks | Time to first platelet counts ≥ 50 × 10⁹/L. |
Countries
China
Contacts
CONTACTCong Wei
PRINCIPAL_INVESTIGATORHou
Qilu Hospital of Shandong University
Outcome results
None listed