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.
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.
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.