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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Cong Wei
Cong.Wei@dizalpharma.com
021-61095755
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 60
Treatments
Experimental: DZD8586 dose level 1
Administered orally, once daily.
Experimental: DZD8586 dose level 2
Administered orally, once daily.
Experimental: DZD8586 dose level 3
Administered orally, once daily.
Sponsors
Leads: Dizal Pharmaceuticals

This content was sourced from clinicaltrials.gov

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