DZD8586 treatment for adults with primary immune thrombocytopenia (ITP)
Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)
Run by Dizal Pharmaceuticals · NCT07294365 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Dizal Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | July 2027 |
| Study ends | December 2027 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT07294365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: DZD8586 is investigational so direct data are limited, although other targeted agents and thrombopoietin receptor agonists have produced benefit in refractory ITP populations.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Principal investigator: Hou — Qilu Hospital of Shandong University
- Study coordinator: Cong Wei
- Email: Cong.Wei@dizalpharma.com
- Phone: 021-61095755
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Teriflunomide plus high-dose dexamethasone versus high-dose dexamethasone alone for adults with newly diagnosed ITP
This trial tests whether adding teriflunomide to high-dose dexamethasone helps adults with newly diagnosed immune thrombocytopenia raise platelet counts and control bleeding better than dexamethasone alone.
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Budoprutug for adults with immune thrombocytopenia (ITP)
This trial will test whether two IV doses of budoprutug are safe and can help raise platelet counts in adults with ITP who still have platelets under 30,000/µL after prior treatment.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.