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

Primary Immune Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232149
• Other study ID #: ICP-CL-00116
• Status: Recruiting
• Phase: Phase 2
• Start date: February 21, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2023
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: Ming Hou, PhD
• Phone: 18560087007
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Males or females aged from 18 to 80 years (including the marginal values).

3. With a body weight of = 35 kg at screening.

4. Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (= 12 months) ITP is met

5. Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.

6. 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.

7. 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:

1. Severe hemorrhage occurred within 4 weeks prior to screening.

2. Subjects suffer from severe ITP at screening

3. Subjects have other diseases which mention in protocol

4. Subjects develop intracranial hemorrhage within 6 months prior to screening.

5. Active and uncontrollable infection

6. Subjects have a history of coagulopathy other than ITP

7. Subjects with a history of malignancies.

8. History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.

9. Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.

10. Subjects with a Medication history and surgical history which mention in protocol

11. Subjects do not meet the criterion of the laboratory test in protocol

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

Related Conditions & MeSH terms

• Primary Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Orelabrutinib( lower dose)
Orelabrutinib is a white, round, uncoated tablet, will be taken lower dose QD by patients with persistent or chronic primary immune thrombocytopenia
• Orelabrutinib( higher dose)
Orelabrutinib is a white, round, uncoated tablet, will be taken higher dose QD by patients with persistent or chronic primary immune thrombocytopenia

Locations

Country	Name	City	State
China	Hainan People's Hospital	HaiKou	Hainan
China	QiLu Hospital of Shandong University	JiNan	Shandong
China	First Hospital of Nanchang University	NanChang	Jiangxi
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	WuHan	Hubei
China	Wuxi People's Hospital	WuXi	Jiangsu
China	Affiliated Hospital of Xuzhou Medical University	XuZhou	Jiangsu
China	Yichang Central People's Hospital	YiChang	Hubei
China	Henan Tumor Hospital	ZhengZhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	ZhengZhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cmax	To obtain pharmacokinetic (PK) data of Orelabrutinib include the peak plasma concentration (Cmax)	25 weeks
Primary	Proportion of subjects with the platelet count of = 50 × 109/L after 12 weeks of treatment		12 weeks
Secondary	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		25 weeks
Secondary	Occurrence of treatment emergent adverse events (TEAE) and treatment-related adverse events (TRAE) were evaluated according to severity		25 weeks