Actively Recruiting
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2024-08-16
186
Participants Needed
41
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Clinical diagnosis of SLE for at least 6 months meeting at least 4 of 11 ACR criteria
- SLE Disease Activity Index (SLEDAI-2K) score of 8 or higher at screening
- Stable standard of care therapy (glucocorticoids, anti-malarials, or immunosuppressive agents) for at least 30 days before first dose
- Positive test for anti-dsDNA antibody above normal range and/or ANA and/or anti-Smith antibody at screening
- Women of childbearing potential must use a barrier method plus a highly effective contraception method during the trial and for 90 days after last dose
- Voluntarily signed informed consent with understanding of study details
You will not qualify if you...
- Pregnant or breastfeeding women, or men/women planning pregnancy within the past 12 months
- Neuropsychiatric SLE within 6 months prior to first dose (e.g., seizures, psychosis, cerebrovascular events)
- Severe lupus nephritis or recent hemodialysis/high-dose glucocorticoid use within 90 days before first dose
- Autoimmune diseases other than SLE (except secondary Sjogren's syndrome)
- History of treatment with glucocorticoids for more than 2 weeks in last 24 weeks for non-SLE diseases
- History or current diagnosis of central nervous system diseases
- Unstable or untreated cardiovascular disease
- Significant active lung diseases
- Severe liver or biliary diseases
- History of cancer
- History of major organ or stem cell transplant
- Known allergies to study drug components
- Recent use of B cell-depleting therapies, cyclophosphamide, chlorambucil, biologics, or TNF/interleukin blockers within specified timeframes
- Positive HIV, hepatitis B or C tests or abnormal liver/kidney function at screening
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233099
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
4
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Not Yet Recruiting
5
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
6
The First Affiliated Hospital of XiaMen University
Xiamen, Fujian, China, 361009
Actively Recruiting
7
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
8
The first affiliated hospital of shantou university medical college
Shantou, Guangdong, China, 515041
Actively Recruiting
9
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China, 518107
Actively Recruiting
10
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
Actively Recruiting
11
Affiliated Hospital of HeBei University
Baoding, Hebei, China, 071030
Actively Recruiting
12
Hebei People's Hospital
Shijiazhuang, Hebei, China, 050051
Actively Recruiting
13
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China, Contact: Junsong Li
Actively Recruiting
14
The first hospital of Qiqihar
Qiqihar, Heilongjiang, China, 161005
Actively Recruiting
15
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Actively Recruiting
16
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
17
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
18
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
19
Yiyang Central Hospital
Yiyang, Hunan, China, 413000
Actively Recruiting
20
Zhuzhou Central Hospital
Zhuzhou, Hunan, China, 412000
Actively Recruiting
21
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Actively Recruiting
22
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
23
Jiujiang NO.1 People's Hospital
Jiujiang, Jiangxi, China, 332000
Actively Recruiting
24
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
25
Jilin Provincial People's Hospital
Changchun, Jilin, China, 130021
Actively Recruiting
26
Shengjing Hospital of china medical university
Shenyang, Liaoning, China, 110004
Actively Recruiting
27
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Nei Monggol Autonomous Region, China, 010000
Not Yet Recruiting
28
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, China, 256699
Actively Recruiting
29
Jining First People's Hospital
Jining, Shandong, China, 272002
Actively Recruiting
30
Linyi People's Hospital
Linyi, Shandong, China, 276034
Actively Recruiting
31
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
32
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
33
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
34
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
35
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
36
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
37
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China, 830000
Actively Recruiting
38
The Third People's Hospital of Huzhou
Huzhou, Zhejiang, China, 313002
Actively Recruiting
39
The First Hospital of Ningbo
Ningbo, Zhejiang, China, 315010
Actively Recruiting
40
The First People's Hospital of Wenling
Wenling, Zhejiang, China, 317500
Actively Recruiting
41
Wenzhou People's Hospital
Wenzhou, Zhejiang, China, 325099
Actively Recruiting
Research Team
Z
Zhanguo Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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