An Exploratory Study of Golidocitinib in Adult Patients With ITP

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 Criteria:

• 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 Criteria:

• 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.