Golidocitinib: Golidocitinib will be administered orally as capsules in a 28-day cycle.
Placebo: Placebo will be administered orally as capsules in a 28-day cycle.
Study 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Part A: Incidence and severity of Adverse Events (AEs) — 1 year The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Part B: Durable response rate — up to 24 weeks The proportion of patients with a platelet count ≥ 50 × 10⁹/L on at least four of six scheduled visits between weeks 14 and 24
Trial sites (1)
Facility
City
Region
Status
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing
Beijing Municipality
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.