DZD8586 treatment for adults with primary immune thrombocytopenia (ITP)

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

This trial will try different doses of the experimental drug DZD8586 to see if it raises platelet counts and is safe in adults with primary ITP who did not respond to at least one standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dizal Pharmaceuticals (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07294365 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, open-label, randomized, multicenter study enrolling adults with persistent or chronic primary ITP and low platelet counts (<30 × 10⁹/L) who failed at least one standard therapy. Eligible participants will be randomized to one of three dose levels of DZD8586 and followed for platelet response and safety outcomes. The protocol includes regular monitoring of platelet counts and adverse events, with exclusion of secondary causes of thrombocytopenia, active infection, severe cardiac disease, and pregnancy. The goal is to characterize dose-related effects on platelet recovery and tolerability in this refractory ITP population.

Who should consider this trial

Good fit: Adults (≥18 years) with persistent or chronic primary ITP, average platelet counts under 30 × 10⁹/L, who have failed at least one standard ITP treatment and have adequate organ function are the intended participants.

Not a fit: Patients with secondary thrombocytopenia, active infections, severe cardiac abnormalities, pregnancy or breastfeeding, or those receiving prohibited prior or current treatments are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, DZD8586 could raise platelet counts and reduce bleeding risk for patients with refractory primary ITP.

How similar studies have performed: DZD8586 is investigational so direct data are limited, although other targeted agents and thrombopoietin receptor agonists have produced benefit in refractory ITP populations.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Hou — Qilu Hospital of Shandong University
• Study coordinator: Cong Wei

Conditions Immune Thrombocytopenia