Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
NCT ID: NCT05688696
Last Updated: 2024-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
186 participants
INTERVENTIONAL
2023-04-29
2026-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Orelabrutinib Lower Dose
Orelabrutinib (Low Dose)
Subjects will be administered with lower dose of Orelabrutinib orally once daily in combination with SOC therapy
Orelabrutinib Higher Dose
Orelabrutinib (High Dose)
Subjects will be administered with higher dose of Orelabrutinib orally once daily in combination with SOC therapy
Placebo
Orelabrutinib Placebo
Subjects will be administered with Orelabrutinib Placebo orally once daily in combination with SOC therapy
Interventions
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Orelabrutinib (Low Dose)
Subjects will be administered with lower dose of Orelabrutinib orally once daily in combination with SOC therapy
Orelabrutinib (High Dose)
Subjects will be administered with higher dose of Orelabrutinib orally once daily in combination with SOC therapy
Orelabrutinib Placebo
Subjects will be administered with Orelabrutinib Placebo orally once daily in combination with SOC therapy
Eligibility Criteria
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Inclusion Criteria
2. Males or females aged≥18 and ≤75 years.
3. Have a clinical diagnosis of SLE 6 months prior to signing the ICF, meeting at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
4. SLEDAI-2K≥8 at screening.
5. Are on a stable SLE SOC therapy consisting of any of the following medications for a period of at least 30 days prior to the first dose: glucocorticoid, and/or anti-malarials, and/or immunosuppressive agents.
6. Have a positive test for anti-dsDNA antibody (\> normal range) and/or anti-nuclear antibody (ANA) and/or anti-Smith antibody at screening.
7. 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 agent. In this trial.
Exclusion Criteria
1. Pregnant or lactating women, and men or women who have birth plans in the past 12 months.
2. Have neuropsychiatric systemic lupus erythematosus (NPSLE) within 6 months prior to the first dose, including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cranial neuropathy, cerebritis, cerebral vasculitis or lupus headache.
3. Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.
4. Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).
5. Have a history of any non-SLE disease that has required treatment with oral or intravenous or intramuscular or subcutaneous injection glucocorticoids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
6. Have a history of or current diagnosis of Central Nervous System (CNS) diseases.
7. Have clinically documented cardiovascular diseases that are obviously unstable or not effectively treated.
8. Have significant active lung diseases (e.g., interstitial lung disease, obstructive pulmonary disease).
9. Have severe hepatobiliary diseases.
10. Have a history of malignant neoplasm.
11. Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
12. Have known allergies to any component of the investigational agent as described in the Protocol.
Concomitant medication and surgery:
13. Have received rituximab, epratuzumab, or any other B cell-depleting therapy within 12 months prior to randomization.
14. Have received cyclophosphamide and chlorambucil within 6 months prior to randomization.
15. Have received belimumab, tumor necrosis factor (TNF) blockers, interleukin receptor blockers or other biological agents within 3 months prior to randomization (or 5 half-lives, whichever is longer).
Lab tests:
16. Have a positive test for human immunodeficiency virus (HIV) antibody.
17. Have a positive test for Hepatitis B Surface Antigen (HBsAg) or hepatitis C antibody, or have a positive test for hepatitis B virus (HBV) DNA by Polymerase Chain Reaction (PCR) if positive for Hepatitis B Core Antibody (HBcAb).
18. Have abnormal tissue or organ function, meeting any of the following at screening:
* Absolute neutrophil count (ANC) \< 1.5 × 10\^9/L; hemoglobin \< 90 g/L; lymphocyte count \< 0.8 × 10\^9 /L.
* Calculated estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 45 mL/min/1.73 m2.
Others:
19. Have other conditions that are not appropriate for participation in the trial as considered by the investigator.
18 Years
75 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of XiaMen University
Xiamen, Fujian, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
The first affiliated hospital of shantou university medical college
Shantou, Guangdong, China
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Affiliated Hospital of HeBei University
Baoding, Hebei, China
Hebei People's Hospital
Shijiazhuang, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The first hospital of Qiqihar
Qiqihar, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
Yiyang Central Hospital
Yiyang, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiujiang NO.1 People's Hospital
Jiujiang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Provincial People's Hospital
Changchun, Jilin, China
Shengjing Hospital of china medical university
Shenyang, Liaoning, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Nei Monggol Autonomous Region, China
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, China
Jining First People's Hospital
Jining, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
The Third People's Hospital of Huzhou
Huzhou, Zhejiang, China
The First Hospital of Ningbo
Ningbo, Zhejiang, China
The First People's Hospital of Wenling
Wenling, Zhejiang, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Changhao Xie
Role: primary
Zongwen Shuai
Role: primary
Zhanguo Li
Role: primary
GuoChun Wang
Role: primary
Yanying Liu
Role: primary
Guixiu Shi
Role: primary
Niansheng Yang
Role: primary
Zhiduo Hou
Role: primary
Ruojie Gu
Role: primary
Baozhen Li
Role: primary
Minghua Xu
Role: primary
Fang Li
Role: primary
Junsong Li
Role: primary
Wei Zhong
Role: primary
Xiaofei Shi
Role: primary
Shengyun Liu
Role: primary
Anbin Huang
Role: primary
Jing Tian
Role: primary
Jian Shi
Role: primary
Zhenhua Wen
Role: primary
Zhichun Liu
Role: primary
Lin Liu
Role: primary
Ju Liu
Role: primary
Rui Wu
Role: primary
Guoping Jiang
Role: primary
Xiaofei Wang
Role: primary
Hongbin Li
Role: primary
Xuebin Wang
Role: primary
Jianhong Zhao
Role: primary
Zunzhong Li
Role: primary
Jie Gao
Role: primary
Sheng Chen
Role: primary
Zili Fu
Role: primary
Xiaoxia Wang
Role: primary
Lan He
Role: primary
Wei Wei
Role: primary
Lijun Wu
Role: primary
Xiaobing Yang
Role: primary
Wen Qin
Role: primary
Yongjun Cheng
Role: primary
Suxian Lin
Role: primary
Other Identifiers
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ICP-CL-00124
Identifier Type: -
Identifier Source: org_study_id
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