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An Exploratory Study of Golidocitinib in Adult Patients With ITP | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

An Exploratory Study of Golidocitinib in Adult Patients With ITP

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

NCT07196163•Peking University People's Hospital

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
•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.

Locations (1)

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

Beijing, Beijing Municipality, China

Key Dates

Start Date

October 30, 2025

Primary Completion Date

October 30, 2028

Completion Date

October 30, 2029

Last Updated

September 29, 2025

Enrollment

138

ESTIMATED participants

Conditions

Immune Thrombocytopenia (ITP)

Interventions

Golidocitinib

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Exploratory Study of Golidocitinib in Adult Patients With ITP

Inclusion Criteria

Exclusion Criteria

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia

Safety Study of CC312 in Autoimmune Disease Patients

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia

An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia