RecruitingPhase 2NCT05680480

A Study of Telitacicept in Lupus Nephritis

A Phase Ⅱ, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis

Sponsor

RemeGen Co., Ltd.

Enrollment

120 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

Lupus Nephritis

Summary

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a biological treatment called Telitacicept 160 mg, and others for people with lupus nephritis. The study is currently recruiting participants at 45 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALTelitacicept 240 mg

Participants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.

BIOLOGICALTelitacicept 160 mg

Participants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.

DRUGPlacebo

Participants will receive placebo weekly in addition to SOC for 48 weeks.

Locations(45)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Hospital Affiliated to the Army Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Liuzhou Workers' Hospital

Liuzhou, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Handan First Hospital

Handan, Hebei, China

Hebei General Hospital

Shijiazhuang, Hebei, China

The Third Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

General Hospital of Northern Theater Command of the Chinese People's Liberation Army

Shenyang, Liaoning, China

The Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

People's Hospital of Sichuan Province

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, China

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Yiwu, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05680480

Related Trials

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

NCT0761121415 locations

A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease

NCT0692554214 locations

US Zamto-cel Autoimmune Diseases

NCT067088451 location

A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)

NCT0655726519 locations

A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

NCT06581198101 locations