An Exploratory Study of Golidocitinib in Adult Patients With ITP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Golidocitinib, Placebo.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia (ITP). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploratory Clinical Study of Golidocitinib in Adult Patients With Primary Immune Thrombocytopenia (ITP)
Overview
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.
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.
Primary outcome measures
- Part A: Incidence and severity of Adverse Events (AEs) [Time frame: 1 year]
- Part B: Durable response rate [Time frame: up to 24 weeks]
Secondary outcome measures (12)
- Part A: Durable response rate [Time frame: up to 24 weeks]
- Part B: Incidence and severity of Adverse Events (AEs) [Time frame: 1 year]
- Part A and Part B: Overall response rate [Time frame: up to 24 weeks]
- Part A and Part B: Complete response rate [Time frame: up to 24 weeks]
- Part A and Part B: Early response rate [Time frame: up to 1 week]
- Part A and Part B: Initial response rate [Time frame: up to 4 weeks]
- Part A and Part B: Sustained response rate [Time frame: up to 24 weeks]
- Part A and Part B: Time to response [Time frame: up to 24 weeks]
- Part A and Part B: Cumulative response time [Time frame: up to 24 weeks]
- Part A and Part B: The proportion of patients requiring rescue therapy [Time frame: up to 24 weeks]
- Part A and Part B: The proportion of patients experencing bleeding (≥ Grade 2) [Time frame: up to 24 weeks]
- Part A and Part B: Changes of ITP-BAT bleeding score [Time frame: up to 24 weeks]
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Insititute of Hematology, Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07196163 · DZ2024J0003