Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Primary Immune Thrombocytopenia (ITP)
• Intervention / Treatment: Drug: Placebo; Drug: Orelabrutinib

• Study Type: Interventional
• Enrollment (Estimated): 195
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexia Lu; Phone Number: 010-66609745; Email: CO_HGRAC@innocarepharma.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical College
      • Contact: Feng Zhang
    • Hefei, Anhui, China, 230022
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Qingshu Zeng
  • Beijing
    • Beijing, Beijing, China, 100044
      • Not yet recruiting
      • Peking University People's Hospital
      • Contact: Xiaohui Zhang
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Beijing CHAO-YANG Hospital Capital Medcal University
      • Contact: WenMing Chen
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Not yet recruiting
      • Xinqiao Hospital of Army Medical University
      • Contact: Yimei Feng
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Not yet recruiting
      • Fujian Medical University Union Hospital
      • Contact: Fenge Yang
    • Xiamen, Fujian, China, 361004
      • Not yet recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Bing Xu
    • Xiamen, Fujian, China, 361004
      • Not yet recruiting
      • Zhongshan Hospital Xiamen University
      • Contact: Quanyi Lu
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Recruiting
      • Gansu Provincial Hospital
      • Contact: Qike Zhang
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Jing Sun
    • Shenzhen, Guangdong, China, 518052
      • Recruiting
      • Huazhong University of Science and Technology Union Shenzhen Hospital
      • Contact: Zhi Guo
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Jingyu Zhang
    • Tangshan, Hebei, China, 063000
      • Not yet recruiting
      • North China University of Science and Technology Affiliated Hospital
      • Contact: Zhenyu Yan
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Not yet recruiting
      • The Second Affiliated Hospital of Harbin Medical University
      • Contact: Wei Wang
  • Henan
    • Luoyang, Henan, China, 471000
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Contact: Ling Qin
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • the First Affiliated Hospital of Zhengzhou University
      • Contact: Fang Wang
    • Zhengzhou, Henan, China, 450004
      • Recruiting
      • Henan Cancer Hospital
      • Contact: hu Zhou
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Heng Mei
    • Wuhan, Hubei, China, 430030
      • Not yet recruiting
      • TongJi Medical College of HUST
      • Contact: Dengju Li
    • Yichang, Hubei, China, 443008
      • Recruiting
      • Yichang Central People's Hospital
      • Contact: Jingming Guo
  • Hunan
    • Changsha, Hunan, China, 410008
      • Not yet recruiting
      • Xiangya Hospital Central South University
      • Contact: yajing xu
    • Chenzhou, Hunan, China, 423003
      • Recruiting
      • Chenzhou First People's Hospital
      • Contact: Xinquan Liang
    • Yongzhou, Hunan, China, 425006
      • Recruiting
      • The Central Hospital of Yongzhou
      • Contact: Shibin Deng
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010000
      • Not yet recruiting
      • Affiliated Hospital of Inner Mongolia Medical University
      • Contact: Da Guo
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Not yet recruiting
      • Jiangsu Province Hospital
      • Contact: Guangsheng He
    • Nanjing, Jiangsu, China, 210000
      • Not yet recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Rongfu Zhou
    • Wuxi, Jiangsu, China, 214000
      • Recruiting
      • Wuxi People's Hospital
      • Contact: Xin Zhou
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Ruibin Huang
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • Jiangxi Provincial People's Hospital
      • Contact: Chenghao Jin
  • Liaoning
    • Shenyang, Liaoning, China, 110002
      • Not yet recruiting
      • The First Hospital of China Medical University
      • Contact: xiaojing Yan
  • Shandong
    • Dezhou, Shandong, China, 253000
      • Not yet recruiting
      • Qilu Hospital of Shandong University Dezhou Hospital
      • Contact: Lin Wang
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Ming Hou, PhD; Phone Number: 18560087007; Email: houming@medmail.com.cn
  • Shanghai
    • Shanghai, Shanghai, China, 200020
      • Not yet recruiting
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Junmin Li
  • Shanxi
    • Xi'an, Shanxi, China, 710068
      • Recruiting
      • Shaanxi provincial people's hospital
      • Contact: yi wang
    • Xi'an, Shanxi, China, 710061
      • Not yet recruiting
      • The First Affiliated Hospital of Xi 'An Jiaotong University
      • Contact: Pengcheng He
    • Xi'an, Shanxi, China, 710003
      • Recruiting
      • Xi'an Central Hospital
      • Contact: Yanping Song
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Rong Xiao
    • Luzhou, Sichuan, China, 646000
      • Not yet recruiting
      • The Affilated Hospital of Southwest Medical University
      • Contact: XIAOMING LI
    • Yibin, Sichuan, China, 644000
      • Not yet recruiting
      • The Second People's Hospital of Yibin
      • Contact: shihua huang
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
      • Contact: Lei Zhang
    • Tianjin, Tianjin, China, 300052
      • Not yet recruiting
      • Tianjin Medical University General Hospital
      • Contact: Rong Fu
  • Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000
      • Not yet recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Xinhong Guo
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Recruiting
      • The Second Affiliated Hospital of Kunming Medical University
      • Contact: Zeping Zhou
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Jie Jin
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Provincial Hospital of Chinese Medicine
      • Contact: Baodong Ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. In accordance with the diagnosis of chronic (≥ 12 months) ITP
5. 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.
6. 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:

1. Severe hemorrhage occurred within 4 weeks prior to screening.
2. Subjects suffered from severe ITP at screening and were not eligible for participation in this study as judged by the investigator.
3. 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.
4. Subjects had multiple immune hemocytopenia.
5. Subjects had inherited thrombocytopenia or secondary ITP.
6. Subjects had a history of arterial or venous thromboembolism within 6 months prior to screening.
7. Received prohibited medications within protocol-specified period before the first dose.
8. Received blood transfusion (including platelet transfusion) within 2 weeks prior to the first dose of the investigational drug.
9. 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).
10. 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.
11. Received a major surgery (including splenectomy) or trauma (except biopsy) within 28 days prior to the first dose of the investigational drug, or expected to receive a major surgery during the study treatment period.
12. Received splenectomy and had a prior history of overwhelming post-splenectomy infection (OPSI).
13. Had a history of alcohol or drug abuse currently or within the past 1 year, excepting nicotine and caffeine.
14. Received a COVID-19 vaccine, live vaccine, or live-attenuated vaccine within 1 month prior to screening or during the screening period.
15. Previous exposure to BTK inhibitors.
16. Laboratory results did not meet protocol requirements.
17. Pregnant or lactating women.
18. Subjects whose blood cannot be collected, or who had contraindications for blood collection.
19. Other conditions that were not appropriate for participation in the trial as considered by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo once daily (QD)
Experimental: Orelabrutinib	Drug: Orelabrutinib; Orelabrutinib once daily (QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Durable response rate	Throughout the study period, an average of 6 months

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Cytopenia; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: ICP-CL-00126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No