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

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

Study Overview

• Status: Recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Biological: Telitacicept 240 mg; Biological: Telitacicept 160 mg; Drug: Placebo

Detailed Description

This is a phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept versus placebo while taking standard of care (SOC) treatment in adult subjects with active proliferative lupus nephritis (LN).

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Binghua Xiao; Phone Number: 86-010-58076833; Email: binghua.xiao@remegen.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • The First Hospital Affiliated to the Army Medical University
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
    • Xiamen, Fujian, China, 361004
      • Recruiting
      • Zhongshan Hospital Affiliated to Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangdong Provincial People's Hospital
  • Guangxi
    • Liuzhou, Guangxi, China, 545005
      • Recruiting
      • Liuzhou Workers' Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550002
      • Recruiting
      • Guizhou Provincial People's Hospital
  • Hebei
    • Baoding, Hebei, China, 071000
      • Recruiting
      • Affiliated Hospital of Hebei University
    • Handan, Hebei, China, 056002
      • Recruiting
      • Handan First Hospital
    • Shijiazhuang, Hebei, China, 050051
      • Recruiting
      • Hebei General Hospital
    • Shijiazhuang, Hebei, China, 050051
      • Recruiting
      • The Third Affiliated Hospital of Hebei Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410013
      • Recruiting
      • The Third Xiangya Hospital of Central South University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014017
      • Recruiting
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
    • Wuxi, Jiangsu, China, 214023
      • Recruiting
      • Wuxi People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Chang chun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130042
      • Recruiting
      • The Second Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital of China Medical University
    • Shenyang, Liaoning, China, 110015
      • Recruiting
      • General Hospital of Northern Theater Command of the Chinese People's Liberation Army
  • Qinghai
    • Xining, Qinghai, China, 810001
      • Recruiting
      • The Affiliated Hospital of Qinghai University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Recruiting
      • Second Affiliated Hospital of Xi'an JiaoTong University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital Of Shandong University
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • The Affiliated Hospital of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital affiliated to Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Recruiting
      • Shanxi Provincial People's Hospital
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 030032
      • Recruiting
      • Shanxi Bethune Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital Sichuan University
    • Chengdu, Sichuan, China, 610072
      • Recruiting
      • People's Hospital of Sichuan Province
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China, 300211
      • Recruiting
      • Tianjin Medical University Second Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830001
      • Recruiting
      • People's Hospital of Xinjiang Uygur Autonomous Region
    • Urumqi, Xinjiang, China, 830054
      • Recruiting
      • The first affiliated hospital of Xinjiang medical university
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Linhai, Zhejiang, China, 317000
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
    • Yiwu, Zhejiang, China, 322000
      • Recruiting
      • The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Males or females aged 18-75 years of age, inclusive.
2. Diagnosis of systemic lupus erythematosus according to American College of Rheumatology criteria (1997).
3. Active, biopsy-proven proliferative lupus nephritis Class III or IV with/without the presence of Class V, or pure Class V according to the 2003 ISN/RPS classification. The renal biopsy must be performed within 1 year prior to the screening visit or during screening period. The biopsy report will be used to confirm subject eligibility.
4. Positive serum antibody results, defined as positive anti-nuclear antibody (ANA) and/or a positive anti-dsDNA serum antibody based on the study's central laboratory results.
5. Active renal disease at screening requiring induction therapy with high dose corticosteroids (HDCS) with mycophenolate mofetil (MMF) or other oral forms of mycophenolate.
6. Induction therapy for active renal disease: HDCS with mycophenolate mofetil (MMF) or other oral forms of mycophenolate should be initiated within 60 days prior to or on Day 1 (baseline). Initiation of induction is when both HDCS and MMF have been started.
7. Able to understand the requirements of the study and provide written informed consent.

Main Exclusion Criteria:

1. Known hypersensitivity or contraindication to any drug products they plan to receive (e.g., MMF, corticosteroids).
2. History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.

3. Received any of the following therapies:

   1. Treatment with any B cell targeted therapy (e.g., rituximab), unless it can be shown that B cells have returned to baseline level or normal;
   2. Received tumor necrosis factor inhibitors, interleukin receptor blockers, or other small molecules or biologics (including Belimumab) during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
   3. Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
   4. Received plasma separation or plasma exchange during the 6 weeks prior to screening;
   5. Subjects who required dialysis within 1 year prior to screening.
   6. Received a live vaccine or live-attenuated vaccine within 4 weeks prior to screening or expected to vaccinate during the study.
   7. Received BCG Vaccine within 1 year prior to screening.
4. History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1).
5. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant or are due to receive transplantation.
6. Significant, unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
7. Plan to undergo surgery or have any medical disease, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
8. History of drug or alcohol abuse or dependence within 364 days prior to baseline (Day 1).
9. Nursing or pregnant female, or male or female who prepared for parenthood during the study.
10. History of malignant tumors within the last 5 years, excluding adequately treated skin cancer (basal or squamous cell) or carcinoma in situ of cervix.
11. Have acute or chronic infection requiring treatment.
12. HIV positive.
13. Hepatitis B: Patients positive for HBsAg are excluded; Patients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require test for HBV DNA: if HBV DNA positive, patients will be excluded; if HBV DNA negative, patients will be eligible to enroll.
14. Hepatitis C antibody positive.
15. History of COVID-19 within 4 weeks prior to screening or history of hospitalization due to severe Covid-19 within 12 months prior to screening.
16. eGFR<30 mL/min/1.73 m2 using CKD-EPI.
17. Renal biopsy showed 50% glomerulosclerosis.
18. Subjects who in the opinion of the investigator are not suitable to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept 240 mg; Telitacicept 240 mg given SC weekly plus standard therapy through week 48.	Biological: Telitacicept 240 mg; Participants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.; Other Names: RC18 240 mg
Experimental: Telitacicept 160 mg; Telitacicept 160 mg given SC weekly plus standard therapy through week 48.	Biological: Telitacicept 160 mg; Participants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.; Other Names: RC18 160 mg
Placebo Comparator: Placebo; Placebo given SC weekly plus standard therapy through week 48.	Drug: Placebo; Participants will receive placebo weekly in addition to SOC for 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Complete Renal Response (CRR)	CRR is defined as estimated glomerular filtration rate (GFR) is no more than 20% below the baseline value or ≥ 60 mL/min/1.73m^2 and 24-hour urinary protein: creatinine ratio ≤ 0.5 mg/mg and did not receive prohibited or rescue therapy resulting in treatment failure.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with Partial Renal Response (PRR)	PRR is defined as 24-hour urinary protein: creatinine ratio reduced by 50% compared to baseline value.	Week 24 and Week 48
Incidence of AE, SAE	An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose resulting in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment.	Up to Week 48

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: December 26, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: lupus; nephritis; Telitacicept; RC 18
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Lupus Nephritis
• Other Study ID Numbers: 18C030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No