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A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia

Primary Purpose

Primary Immune Thrombocytopenia

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Orelabrutinib( lower dose)

Orelabrutinib( higher dose)

About this trial

This is an interventional treatment trial for Primary Immune Thrombocytopenia focused on measuring Persistent or chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met
Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.
Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug.
The mean of two platelet counts is less than 30 × 109/L and no platelet count is greater than 35 × 109/L during the screening visit and/or before the first dose.

Exclusion Criteria:

Severe hemorrhage occurred within 4 weeks prior to screening.
Subjects suffer from severe ITP at screening
Subjects have other diseases which mention in protocol
Subjects develop intracranial hemorrhage within 6 months prior to screening.
Active and uncontrollable infection
Subjects have a history of coagulopathy other than ITP
Subjects with a history of malignancies.
History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.
Subjects with a Medication history and surgical history which mention in protocol
Subjects do not meet the criterion of the laboratory test in protocol

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

Hainan People's HospitalRecruiting
Henan Tumor HospitalRecruiting
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Yichang Central People's HospitalRecruiting
Wuxi People's HospitalRecruiting
Affiliated Hospital of Xuzhou Medical UniversityRecruiting
First Hospital of Nanchang UniversityRecruiting
QiLu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lower Dose

Higher Dose

Arm Description

Orelabrutinib is a white, round, uncoated tablet

Outcomes

Primary Outcome Measures

Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment

Secondary Outcome Measures

Proportion of subjects who achieve a complete response (CR) over treatment time. CR is defined as a post-treatment platelet count of ≥100 × 109/L

Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity

Full Information

NCT ID

NCT05232149

First Posted

December 20, 2021

Last Updated

January 10, 2023

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05232149

Brief Title

A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia

Official Title

A Randomized, Multi-center, Adaptive Phase IIa/IIb Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Persistent or Chronic Primary Immune Thrombocytopenia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 21, 2022 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial. Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety follow-up period Phase IIb: At present, a preliminary exploratory study (i.e., phase IIa study) will be conducted first. The design of the phase IIb study (including the selection of populations) will be clarified after a relatively clear understanding of the therapeutic effect, value, risks and benefits of the BTK inhibitor for ITP is obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Immune Thrombocytopenia

Keywords

Persistent or chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lower Dose

Arm Type

Experimental

Arm Description

Orelabrutinib is a white, round, uncoated tablet

Arm Title

Higher Dose

Arm Type

Experimental

Arm Description

Orelabrutinib is a white, round, uncoated tablet

Intervention Type

Drug

Intervention Name(s)

Orelabrutinib( lower dose)

Intervention Description

Orelabrutinib is a white, round, uncoated tablet, will be taken lower dose QD by patients with persistent or chronic primary immune thrombocytopenia

Intervention Type

Drug

Intervention Name(s)

Orelabrutinib( higher dose)

Intervention Description

Orelabrutinib is a white, round, uncoated tablet, will be taken higher dose QD by patients with persistent or chronic primary immune thrombocytopenia

Primary Outcome Measure Information:

Title

Proportion of subjects with the platelet count of ≥ 50 × 109/L after 12 weeks of treatment

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Proportion of subjects who achieve a complete response (CR) over treatment time. CR is defined as a post-treatment platelet count of ≥100 × 109/L

Time Frame

25 weeks

Title

Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity

Time Frame

25 weeks

Other Pre-specified Outcome Measures:

Title

Cmax

Description

To obtain pharmacokinetic (PK) data of Orelabrutinib include the peak plasma concentration (Cmax)

Time Frame

25 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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. Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy. Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug. The mean of two platelet counts is less than 30 × 109/L and no platelet count is greater than 35 × 109/L during the screening visit and/or before the first dose. Exclusion Criteria: Severe hemorrhage occurred within 4 weeks prior to screening. Subjects suffer from severe ITP at screening Subjects have other diseases which mention in protocol Subjects develop intracranial hemorrhage within 6 months prior to screening. Active and uncontrollable infection Subjects have a history of coagulopathy other than ITP Subjects with a history of malignancies. History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation. Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients. Subjects with a Medication history and surgical history which mention in protocol Subjects do not meet the criterion of the laboratory test in protocol NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Hou, PhD

Phone

18560087007

houming@medmail.com.cn

Facility Information:

Facility Name

Hainan People's Hospital

City

HaiKou

State/Province

Hainan

ZIP/Postal Code

570100

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li'e Lin

Facility Name

Henan Tumor Hospital

City

ZhengZhou

State/Province

Henan

ZIP/Postal Code

450000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hu Zhou

Facility Name

The First Affiliated Hospital of Zhengzhou University

City

ZhengZhou

State/Province

Henan

ZIP/Postal Code

450000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fang Wang

Facility Name

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

City

WuHan

State/Province

Hubei

ZIP/Postal Code

430000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heng Mei, PhD

Facility Name

Yichang Central People's Hospital

City

YiChang

State/Province

Hubei

ZIP/Postal Code

443000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingming Guo

Facility Name

Wuxi People's Hospital

City

WuXi

State/Province

Jiangsu

ZIP/Postal Code

214000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Zhou

Facility Name

Affiliated Hospital of Xuzhou Medical University

City

XuZhou

State/Province

Jiangsu

ZIP/Postal Code

221000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhenyu Li

Facility Name

First Hospital of Nanchang University

City

NanChang

State/Province

Jiangxi

ZIP/Postal Code

330000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruibin Huang

Facility Name

QiLu Hospital of Shandong University

City

JiNan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Hou

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia

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