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A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

ConditionImmune Thrombocytopenia (ITP)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DZD8586 dose level 1

    Drug

    DZD8586 will be administered orally in a 28-day cycle.

  • DZD8586 dose level 2

    Drug

    DZD8586 will be administered orally in a 28-day cycle.

  • DZD8586 dose level 3

    Drug

    DZD8586 will be administered orally in a 28-day cycle.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: DZD8586 dose level 1Experimental treatment 1 intervention
Group B: DZD8586 dose level 2Experimental treatment 1 intervention
Group C: DZD8586 dose level 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
within 4 weeks

Secondary outcomes

1

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).

Time frame
30 days after the last dose
2

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.

Time frame
within 12 weeks
3

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.

Time frame
within 24 weeks
4

Time to response

Time to first platelet counts ≥ 50 × 10⁹/L.

Time frame
within 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dizal Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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