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.
Sequential
Golidocitinib
DrugGolidocitinib will be administered orally as capsules in a 28-day cycle.
Placebo
DrugPlacebo will be administered orally as capsules in a 28-day cycle.
Part A: Incidence and severity of Adverse Events (AEs)
The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Part B: Durable response rate
The proportion of patients with a platelet count ≥ 50 × 10⁹/L on at least four of six scheduled visits between weeks 14 and 24
Part A: Durable response rate
The proportion of patients with a platelet count ≥ 50 × 10⁹/L on at least four of six scheduled visits between weeks 14 and 24
Part B: Incidence and severity of Adverse Events (AEs)
The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Part A and Part B: Overall response rate
The proportion of patients with a platelet count ≥ 100 × 10⁹/L on 2 consecutive visits at least 7 days apart and without bleeding
Part A and Part B: Complete response rate
The proportion of patients with a platelet count ≥ 100 × 10⁹/L on 2 consecutive visits at least 7 days apart and without bleeding
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