NCT07196163

An Exploratory Study of Golidocitinib in Adult Patients With ITP

An Exploratory Clinical Study of Golidocitinib in Adult Patients With Primary Immune Thrombocytopenia (ITP)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	Golidocitinib	Golidocitinib will be administered orally as capsules in a 28-day cycle.
DRUG	Placebo	Placebo will be administered orally as capsules in a 28-day cycle.

Timeline

• Start date: 2025-10-30
• Primary completion: 2028-10-30
• Completion: 2029-10-30
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: China