A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

Beijing InnoCare Pharma Tech Co., Ltd.45 sites in 1 country195 target enrollmentOctober 26, 2023

ConditionsChronic Primary Immune Thrombocytopenia (ITP)

InterventionsOrelabrutinib Placebo

DrugsOrelabrutinib Placebo

Overview

Phase: Phase 3
Intervention: Orelabrutinib
Conditions: Chronic Primary Immune Thrombocytopenia (ITP)
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 195
Locations: 45
Primary Endpoint: Durable response rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients with Chronic Primary Immune Thrombocytopenia

Registry

clinicaltrials.gov

Start Date

October 26, 2023

End Date

April 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written ICF before the study.
•Males or females aged from 18 to 80 years (including the marginal values).
•With a body weight of ≥ 35 kg at screening.
•In accordance with the diagnosis of chronic (≥ 12 months) ITP
•Patients who have previously received at least one anti-ITP first-line standard treatment (glucocorticoids and/or intravenous immunoglobulin) cannot maintain efficacy, or relapse, or cannot tolerate standard treatment, or have insufficient response.
•Females of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days after the last administration of the investigational medicinal product (IMP).

Exclusion Criteria

•Severe hemorrhage occurred within 4 weeks prior to screening.
•Subjects suffered from severe ITP at screening and were not eligible for participation in this study as judged by the investigator.
•Subjects had autoimmune systemic diseases other than ITP unless they would not affect the evaluation of the study results in the judgment of the investigator and sponsor medical monitor.
•Subjects had multiple immune hemocytopenia.
•Subjects had inherited thrombocytopenia or secondary ITP.
•Subjects had a history of arterial or venous thromboembolism within 6 months prior to screening.
•Received prohibited medications within protocol-specified period before the first dose.
•Received blood transfusion (including platelet transfusion) within 2 weeks prior to the first dose of the investigational drug.
•Participated in another study of the investigational drug (and/or investigational device) within 30 days or within 5 half-lives prior to screening (whichever is longer), or is currently participating in another study of the investigational drug (and /or investigational device).
•The last administration of strong CYP3A inhibitors or strong CYP3A inducers (include food, western medicine, traditional Chinese medicine) is within 14 days (or 5 half-lives, whichever is longer) prior to the first dose, or planned to take a drug or food with a strong inhibition or induction of CYP3A during the study period.