Evaluating a new treatment for 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

This study is testing a new medication called orelabrutinib to see if it helps adults with systemic lupus erythematosus feel better while they are already on standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: rituximab, epratuzumab, belimumab, cyclophosphamide, orelabrutinib
• Locations: 41 sites (Bengbu, Anhui and 40 other locations)
• Trial ID: NCT05688696 on ClinicalTrials.gov

What this trial studies

This phase IIb clinical trial is designed to assess the efficacy and safety of orelabrutinib in adult patients diagnosed with systemic lupus erythematosus (SLE) who are already receiving standard of care therapy. The study is randomized, double-blind, and placebo-controlled, meaning participants will be assigned to receive either the medication or a placebo without knowing which they are receiving. The trial will involve multiple centers and aims to gather data on how well orelabrutinib works in managing SLE symptoms and its safety profile. Participants will be monitored for their response to treatment over a specified period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of systemic lupus erythematosus who are on stable standard of care therapy.

Not a fit: Patients who do not have a clinical diagnosis of systemic lupus erythematosus or those who are not on stable standard of care therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with systemic lupus erythematosus, potentially improving their quality of life.

How similar studies have performed: Other studies have explored treatments for systemic lupus erythematosus, but the specific use of orelabrutinib in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 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).
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:

Medical conditions:

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.

Where this trial is running

Bengbu, Anhui and 40 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)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of XiaMen University — Xiamen, Fujian, China (Recruiting)
• The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• The first affiliated hospital of shantou university medical college — Shantou, Guangdong, China (Recruiting)
• The Seventh Affiliated Hospital, Sun Yat-sen University — Shenzhen, Guangdong, China (Recruiting)
• Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (Recruiting)
• Affiliated Hospital of HeBei University — Baoding, Hebei, China (Recruiting)
• Hebei People's Hospital — Shijiazhuang, Hebei, China (Recruiting)
• Daqing Oilfield General Hospital — Daqing, Heilongjiang, China (Recruiting)
• The first hospital of Qiqihar — Qiqihar, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
• First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• The Second XIANGYA Hospital Of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Yiyang Central Hospital — Yiyang, Hunan, China (Recruiting)
• Zhuzhou Central Hospital — Zhuzhou, Hunan, China (Recruiting)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Recruiting)
• Jiujiang NO.1 People's Hospital — Jiujiang, Jiangxi, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Jilin Provincial People's Hospital — Changchun, Jilin, China (Recruiting)
• Shengjing Hospital of china medical university — Shenyang, Liaoning, China (Recruiting)
• Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Nei Monggol Autonomous Region, China (Not_yet_recruiting)
• Affiliated Hospital of Binzhou Medical College — Binzhou, Shandong, China (Recruiting)
• Jining First People's Hospital — Jining, Shandong, China (Recruiting)
• Linyi People's Hospital — Linyi, Shandong, China (Recruiting)
• Changhai Hospital of Shanghai — Shanghai, Shanghai Municipality, China (Recruiting)
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• The Second Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• The First Affiliated Hospital of Xi 'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Xinjiang Uygur Autonomous Region People's Hospital — Ürümqi, Xinjiang, China (Recruiting)
• The Third People's Hospital of Huzhou — Huzhou, Zhejiang, China (Recruiting)
• The First Hospital of Ningbo — Ningbo, Zhejiang, China (Recruiting)
• The First People's Hospital of Wenling — Wenling, Zhejiang, China (Recruiting)
• Wenzhou People's Hospital — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Zhanguo Li, PhD

Conditions Systemic Lupus Erythematosus, SLE