Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
A Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus
1 other identifier
interventional
186
1 country
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2023
Typical duration for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedStudy Start
First participant enrolled
April 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
ExpectedAugust 16, 2024
August 1, 2024
2.3 years
January 10, 2023
August 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
SLE Responder Index (SRI) - 4 response rate
SRI-4 response is defined as: 1)≥4 point reduction from baseline in SLE disease activity index-2000 (SLEDAI-2K) score; 2) no worsening (increase of \<0.3 points from baseline) in Physician's Global Assessment (PGA); 3) no new A organ domain score or no more than 1 new B organ domain scores compared with baseline in British Isles Lupus Assessment Group (BILAG)-2004.
Week 48
Secondary Outcomes (7)
SLE Responder Index (SRI) - 6 response rate
Week 48
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rate
Week 48
Time to 1st flare
Week 48
The proportion of subjects whose average prednisone dose has been reduced by≥25% from baseline to ≤7.5 mg/day
Week 48
Changes from baseline in the levels of complement C3, complement C4, and anti-dsDNA antibody
Week 48
- +2 more secondary outcomes
Study Arms (3)
Orelabrutinib Lower Dose
EXPERIMENTALOrelabrutinib Higher Dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Subjects will be administered with lower dose of Orelabrutinib orally once daily in combination with SOC therapy
Subjects will be administered with higher dose of Orelabrutinib orally once daily in combination with SOC therapy
Subjects will be administered with Orelabrutinib Placebo orally once daily in combination with SOC therapy
Eligibility Criteria
You may qualify if:
- have had a detailed understanding of the nature, significance, potential benefits, potential risks, and procedures of the study, and voluntarily signed a written Informed Consent Form (ICF).
- Males or females aged≥18 and ≤75 years.
- 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.
- SLEDAI-2K≥8 at screening.
- 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.
- Have a positive test for anti-dsDNA antibody (\> normal range) and/or anti-nuclear antibody (ANA) and/or anti-Smith antibody at screening.
- 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.
You may not qualify if:
- Medical conditions:
- Pregnant or lactating women, and men or women who have birth plans in the past 12 months.
- 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.
- Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.
- Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).
- 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.
- Have a history of or current diagnosis of Central Nervous System (CNS) diseases.
- Have clinically documented cardiovascular diseases that are obviously unstable or not effectively treated.
- Have significant active lung diseases (e.g., interstitial lung disease, obstructive pulmonary disease).
- Have severe hepatobiliary diseases.
- Have a history of malignant neoplasm.
- Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
- Have known allergies to any component of the investigational agent as described in the Protocol.
- Concomitant medication and surgery:
- Have received rituximab, epratuzumab, or any other B cell-depleting therapy within 12 months prior to randomization.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233099, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100000, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
The First Affiliated Hospital of XiaMen University
Xiamen, Fujian, 361009, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
The first affiliated hospital of shantou university medical college
Shantou, Guangdong, 515041, China
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518107, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
Affiliated Hospital of HeBei University
Baoding, Hebei, 071030, China
Hebei People's Hospital
Shijiazhuang, Hebei, 050051, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, Contact: Junsong Li, China
The first hospital of Qiqihar
Qiqihar, Heilongjiang, 161005, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, 410000, China
Yiyang Central Hospital
Yiyang, Hunan, 413000, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
Jiujiang NO.1 People's Hospital
Jiujiang, Jiangxi, 332000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Provincial People's Hospital
Changchun, Jilin, 130021, China
Shengjing Hospital of china medical university
Shenyang, Liaoning, 110004, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Nei Monggol Autonomous Region, 010000, China
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, 256699, China
Jining First People's Hospital
Jining, Shandong, 272002, China
Linyi People's Hospital
Linyi, Shandong, 276034, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, 200000, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710061, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300000, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, 830000, China
The Third People's Hospital of Huzhou
Huzhou, Zhejiang, 313002, China
The First Hospital of Ningbo
Ningbo, Zhejiang, 315010, China
The First People's Hospital of Wenling
Wenling, Zhejiang, 317500, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325099, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2023
First Posted
January 18, 2023
Study Start
April 29, 2023
Primary Completion
August 25, 2025
Study Completion (Estimated)
May 30, 2026
Last Updated
August 16, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share