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NOT YET RECRUITING
NCT07196163
PHASE1/PHASE2

An Exploratory Study of Golidocitinib in Adult Patients With ITP

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2025-10-30

Completion Date

2029-10-30

Last Updated

2025-09-29

Healthy Volunteers

No

Interventions

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.

Locations (1)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China