An Exploratory Study of Golidocitinib in Adult Patients With ITP
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07196163, who can take part
Where in China
- Peking University Insititute of Hematology, Peking University People's HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT07196163
- Record updated
- 29 September 2025
- Original description
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 escalation and Part B dose expansion. Part A is designed to obtain the safety profile of golidocitinib in patients with ITP and the recommended dose for the randomized cohort in Part B. Part B is a randomized, double-blind, placebo-controlled study, and the primary objective of this part is to evaluate the preliminary efficacy of golidocitinib in patients with ITP.Read full original descriptionShow less
An Exploratory Clinical Study of Golidocitinib in Adult Patients With Primary Immune Thrombocytopenia (ITP)
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 escalation and Part B dose expansion. Part A is designed to obtain the safety profile of golidocitinib in patients with ITP and the recommended dose for the randomized cohort in Part B. Part B is a randomized, double-blind, placebo-controlled study, and the primary objective of this part is to evaluate the preliminary efficacy of golidocitinib in patients with ITP.
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: Previous or current therapy and comedications meet exclusion criteria; Previously received JAK inhibitors; Patients with major caridiovascular disease, active infetion, maligancy or uncontrolled systemic disease; History of hypersensitivity to sudy drug with a similar chemical structure or class; Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia; Women who are breast feeding.