Status:
NOT_YET_RECRUITING
An Exploratory Study of Golidocitinib in Adult Patients With ITP
Lead Sponsor:
Peking University People's Hospital
Conditions:
Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicenter clinical study to evaluate the safety and efficacy of golidocitinib in patients with primary immune thrombocytopenia (ITP). The study consists of two parts: Part A dose escalatio...
Eligibility Criteria
Inclusion
- Male and female participants between 18 and 80 years old.
- Primary ITP for \>3 months.
- An average of two platelet counts (⩾ 7 days apart) of \< 30 × 10⁹/L.
- Have relapsed or treatment-resistant to previous ITP therapies, including corticosteroids and at least one other ITP therapy.
- Have history of response to previous treatments.
- Adequate hematologic, hepatic, and renal fuction.
- Participants willing to comply with contraceptive restrictions.
Exclusion
- Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia.
- Previous or current therapy and comedications meet exclusion criteria.
- Patients with major caridiovascular disease, active infetion, maligancy or uncontrolled systemic disease.
- Women who are breast feeding.
- History of hypersensitivity to sudy drug with a similar chemical structure or class.
- Previously received JAK inhibitors.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2029
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT07196163
Start Date
October 30 2025
End Date
October 30 2029
Last Update
September 29 2025
Active Locations (1)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010