Immune Thrombocytopenia (ITP)Phase 2NCT07294365
A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)
A Phase 2 study testing DZD8586 dose level 1, DZD8586 dose level 2 and DZD8586 dose level 3 in people with Immune Thrombocytopenia (ITP), run by Dizal Pharmaceuticals at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- What is being tested?
- DZD8586 dose level 1, DZD8586 dose level 2 and DZD8586 dose level 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have evidence of secondary causes of immune thrombocytopenia.
- Have a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- Any of previous or current treatment prohibited by protocol.
- Any of severe cardiac abnormalities.
- Active infection.
- Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
- Known allergy to DZD8586 drug excipients or other chemical analogues.
- Pregnant or breastfeeding female participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yan Shi, +86 15206660730, shiyansjj@163.com
About this study
Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)
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.
- Conditions
- Immune Thrombocytopenia (ITP)
- Being tested
- DZD8586 dose level 1, DZD8586 dose level 2, DZD8586 dose level 3
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD8586 dose level 1Drug
Also called Birelentinib
DZD8586 will be administered orally in a 28-day cycle.
DZD8586 dose level 2Drug
Also called Birelentinib
DZD8586 will be administered orally in a 28-day cycle.
DZD8586 dose level 3Drug
Also called Birelentinib
DZD8586 will be administered orally in a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| DZD8586 dose level 1 | Experimental | Administered orally, once daily. Receives: Drug: DZD8586 dose level 1 |
| DZD8586 dose level 2 | Experimental | Administered orally, once daily. Receives: Drug: DZD8586 dose level 2 |
| DZD8586 dose level 3 | Experimental | Administered orally, once daily. Receives: Drug: DZD8586 dose level 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (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.
Measured: within 4 weeks
Secondary outcomes (4)
Incidence and severity of Adverse Events (AEs)
Safety profiles, for example, adverse events (AEs), serious adverse events (SAEs), ≥ Grade 3 AEs, etc., per Common Terminology Criteria in Adverse Events (CTCAE).
Measured: 30 days after the last dose
Overall response rate (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.
Measured: within 12 weeks
Durable response rate
The proportion of patients with platelet counts ≥ 50 × 10⁹/L on at least four of six visits between weeks 14 and 24.
Measured: within 24 weeks
Time to response
Time to first platelet counts ≥ 50 × 10⁹/L.
Measured: within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hou, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294365
- Sponsor's protocol ID
- DZ2025B0002
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT07294365
- Acronym / sponsor ID
- DZ2025B0002
- Conditions
- Immune Thrombocytopenia (ITP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DZD8586 dose level 1 | Experimental | Drug: DZD8586 dose level 1Administered orally, once daily. |
| DZD8586 dose level 2 | Experimental | Drug: DZD8586 dose level 2Administered orally, once daily. |
| DZD8586 dose level 3 | Experimental | Drug: DZD8586 dose level 3Administered orally, once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Have evidence of secondary causes of immune thrombocytopenia.
- Have a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- Any of previous or current treatment prohibited by protocol.
- Any of severe cardiac abnormalities.
- Active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD8586 dose level 1Also: BirelentinibDZD8586 will be administered orally in a 28-day cycle. | Drug | DZD8586 dose level 1 |
| DZD8586 dose level 2Also: BirelentinibDZD8586 will be administered orally in a 28-day cycle. | Drug | DZD8586 dose level 2 |
| DZD8586 dose level 3Also: BirelentinibDZD8586 will be administered orally in a 28-day cycle. | Drug | DZD8586 dose level 3 |
Primary outcome
Overall response rate (4 weeks)
Time frame: 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.
4 secondary outcomes
Incidence and severity of Adverse Events (AEs)
Time frame: 30 days after the last dose
Overall response rate (12 weeks)
Time frame: within 12 weeks
Durable response rate
Time frame: within 24 weeks
Time to response
Time frame: within 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hou principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DZD8586 dose level 1, DZD8586 dose level 2 and DZD8586 dose level 3 in people with Immune Thrombocytopenia (ITP), run by Dizal Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cong Wei (021-61095755, Cong.Wei@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (4 weeks) (time frame: within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.