RecruitingPhase 2NCT05688696

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

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

186 participants

Start Date

Apr 29, 2023

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus (SLE)

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Orelabrutinib (High Dose), a drug called Orelabrutinib (Low Dose), and others for people with systemic lupus erythematosus (sle). The study is currently recruiting participants at 41 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib (Low Dose)

Subjects will be administered with lower dose of Orelabrutinib orally once daily in combination with SOC therapy

DRUGOrelabrutinib (High Dose)

Subjects will be administered with higher dose of Orelabrutinib orally once daily in combination with SOC therapy

DRUGOrelabrutinib Placebo

Subjects will be administered with Orelabrutinib Placebo orally once daily in combination with SOC therapy

Locations(41)

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

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