drugset / Trial / NCT07196163

An Exploratory Study of Golidocitinib in Adult Patients With ITP

NCT07196163

Phase 1/2 Not yet recruiting 138 enrolled Peking University People's Hospital
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2025-10-30
Primary completion
2028-10-30
Completion
2029-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Golidocitinib Small molecule Oral