An Exploratory Study of Golidocitinib in Adult Patients With ITP

NCT ID: NCT07196163

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2029-10-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Golidocitinib Part B

Golidocitinib at recommended phase 2 doses, administered orally, once daily.

Group Type: EXPERIMENTAL

Golidocitinib

Intervention Type: DRUG

Golidocitinib will be administered orally as capsules in a 28-day cycle.

Placebo Part B

Placebo at recommended phase 2 doses, administered orally, once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally as capsules in a 28-day cycle.

Golidocitinib Part A

Golidocitinib dose escalation, administered orally, once daily.

Group Type: EXPERIMENTAL

Golidocitinib

Intervention Type: DRUG

Golidocitinib will be administered orally as capsules in a 28-day cycle.

Interventions

Golidocitinib

Golidocitinib will be administered orally as capsules in a 28-day cycle.

Intervention Type: DRUG

Placebo

Placebo will be administered orally as capsules in a 28-day cycle.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Associate Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

DZ2024J0003

Identifier Type: -

Identifier Source: org_study_id