Evaluating Orelabrutinib for Chronic Immune Thrombocytopenia in Adults

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

This study is testing if a new drug called Orelabrutinib can help adults with chronic immune thrombocytopenia raise their platelet counts and feel better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 195 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (industry)
• Drugs / interventions: Orelabrutinib
• Locations: 45 sites (Bengbu, Anhui and 44 other locations)
• Trial ID: NCT06004856 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled Phase III study aimed at assessing the efficacy and safety of Orelabrutinib in adult patients diagnosed with chronic primary immune thrombocytopenia (ITP). Participants will be randomly assigned to receive either the investigational drug or a placebo, with the goal of determining how well Orelabrutinib works in increasing platelet counts and improving patient outcomes. The study will include adults aged 18 to 80 who have had chronic ITP for at least 12 months and have not responded adequately to standard treatments. The trial will monitor both the effectiveness of the treatment and any potential side effects experienced by participants.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with chronic primary immune thrombocytopenia who have previously received at least one standard treatment but did not achieve sufficient results.

Not a fit: Patients who have experienced severe hemorrhage within the last four weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with chronic ITP who have not responded to existing therapies.

How similar studies have performed: Other studies have shown promise with similar treatments for ITP, but this specific approach with Orelabrutinib is being evaluated for the first time in this context.

Eligibility criteria

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.

Where this trial is running

Bengbu, Anhui and 44 other locations

• The first affiliated hospital of bengbu medical college — Bengbu, Anhui, China (RECRUITING)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• Beijing CHAO-YANG Hospital Capital Medcal University — Beijing, Beijing Municipality, China (RECRUITING)
• Peking university People's Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Xinqiao Hospital of Army Medical University — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (NOT_YET_RECRUITING)
• Zhongshan Hospital Xiamen University — Xiamen, Fujian, China (NOT_YET_RECRUITING)
• Gansu Provincial Hospital — Lanzhou, Gansu, China (RECRUITING)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
• Huazhong University of Science and Technology Union Shenzhen Hospital — Shenzhen, Guangdong, China (RECRUITING)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)
• North China University of Science and Technology Affiliated Hospital — Tangshan, Hebei, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Tongji Medical College Of Hust — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Yichang Central People's Hospital — Yichang, Hubei, China (RECRUITING)
• Xiangya Hospital Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Chenzhou First People's Hospital — Chenzhou, Hunan, China (RECRUITING)
• The Central Hospital of Yongzhou — Yongzhou, Hunan, China (RECRUITING)
• Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (NOT_YET_RECRUITING)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Wuxi People's Hospital — Wuxi, Jiangsu, China (RECRUITING)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• The first Hospital of China Medical University — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• Qilu Hospital Of Shandong University Dezhou Hospital — Dezhou, Shandong, China (NOT_YET_RECRUITING)
• Qilu hospital of shandong university — Jinan, Shandong, China (RECRUITING)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Xi'an Central Hospital — Xi’an, Shanxi, China (RECRUITING)
• The First Affiliated Hospital of Xi 'an Jiaotong University — Xi’an, Shanxi, China (NOT_YET_RECRUITING)
• Shaanxi Provincial People'S Hospital — Xi’an, Shanxi, China (RECRUITING)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (RECRUITING)
• The Affilated Hospital of Southwest Medical University — Luzhou, Sichuan, China (NOT_YET_RECRUITING)
• The Second People's Hospital of Yibin — Yibin, Sichuan, China (NOT_YET_RECRUITING)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (RECRUITING)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang Uygur Autonomous Region, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (RECRUITING)
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• Zhejiang Provincial Hospital of Chinese Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Alexia Lu

Conditions: Chronic Primary Immune Thrombocytopenia