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Clinical Trials in China / NCT07196163
Starting soon Phase 1/2

An Exploratory Study of Golidocitinib in Adult Patients With ITP

NCT07196163 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Phase 1/2
Started
2025-10-30
Last updated
2025-09-29

Condition(s) studied

Immune Thrombocytopenia (ITP)

Investigational drug(s) / intervention(s)

Golidocitinib →Placebo

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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. * Previous or current therapy and comedications meet exclusion criteria. * 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.

Primary outcome measure(s)

  • Part A: Incidence and severity of Adverse Events (AEs) — 1 year
    The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.
  • Part B: Durable response rate — up to 24 weeks
    The proportion of patients with a platelet count ≥ 50 × 10⁹/L on at least four of six scheduled visits between weeks 14 and 24

Trial sites (1)

FacilityCityRegionStatus
Peking University Insititute of Hematology, Peking University People's Hospital Beijing Beijing Municipality

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Other trials for the same condition

Longitudinal Observational Study on Immune Thrombocytopenia Starting soon
A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C)in Patients With Refractory Primary Immune Thrombocytopenia Starting soon
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia Recruiting
The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2) Recruiting
Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07196163 on ClinicalTrials.gov ↗ ← All trials in China