Actively Recruiting
A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)
Led by Dizal Pharmaceuticals · Updated on 2026-01-22
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a drug called DZD8586 in adults diagnosed with primary immune thrombocytopenia (ITP) who have not responded to or relapsed after standard treatments. This Phase 2, open-label, randomized study focuses on patients with persistent or chronic primary ITP, aiming to find out how well different doses of DZD8586 work in this population. Participants will be randomly assigned to receive one of three different dose levels of DZD8586, taken orally once a day in 28-day cycles. The study involves multiple centers and assesses the drug's impact over several weeks, monitoring participants through these defined dosing groups. During the study, participants will undergo regular evaluations to measure their platelet counts and response rates at 4, 12, and 24 weeks. Safety will be monitored by tracking adverse events for 30 days after the last dose. Researchers will also observe the time it takes for participants to respond to treatment and the durability of that response. The total duration and detailed follow-up are planned to ensure comprehensive assessment of the treatment's effects.
CONDITIONS
Brief Title
A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants 18 years of age or older
- Diagnosed with persistent or chronic primary ITP with an average of two platelet counts below 30 × 10⁹/L
- Have failed at least one standard treatment for ITP, such as glucocorticoids or IVIG
- Adequate bone marrow reserve and organ functions
- Willing to follow contraceptive restrictions
You will not qualify if you...
- Evidence of secondary causes of immune thrombocytopenia
- History of coagulation disorders other than ITP, including disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
- Previous or current treatments prohibited by the study protocol
- Severe cardiac abnormalities
- Active infection
- Poorly controlled gastrointestinal disorders, inadequate medication absorption, or other systemic diseases
- Known allergy to DZD8586 or similar chemicals
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive daily oral doses of DZD8586 in 28-day cycles while their response and safety are evaluated.
Visits occur regularly during treatment cycles for assessments
Duration - 30 days after the last dose
Participants are monitored for safety and overall response after the last dose of treatment.
1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
C
Cong Wei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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