A Study of Telitacicept in Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680480
• Other study ID #: 18C030
• Status: Recruiting
• Phase: Phase 2
• Start date: April 17, 2023
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: RemeGen Co., Ltd.
• Contact: Binghua Xiao
• Phone: 86-010-58076833
• Email: Binghua.xiao[@]remegen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Biological:
• Telitacicept 240 mg
Participants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.
• Telitacicept 160 mg
Participants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.

Drug:
• Placebo
Participants will receive placebo weekly in addition to SOC for 48 weeks.

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology	Baotou	Inner Mongolia
China	Peking University People's Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Chang chun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	People's Hospital of Sichuan Province	Chengdu	Sichuan
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	The First Hospital Affiliated to the Army Medical University	Chongqing	Chongqing
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	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	Handan First Hospital	Handan	Hebei
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	Hefei	Anhui
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Taizhou Hospital of Zhejiang Province	Linhai	Zhejiang
China	Liuzhou Workers' Hospital	Liuzhou	Guangxi
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	General Hospital of Northern Theater Command of the Chinese People's Liberation Army	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The Third Affiliated Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tianjin Medical University Second Hospital	Tianjin	Tianjin
China	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Zhongshan Hospital Affiliated to Xiamen University	Xiamen	Fujian
China	The Affiliated Hospital of Qinghai University	Xining	Qinghai
China	The Fourth Affiliated Hospital, Zhejiang University School of Medicine	Yiwu	Zhejiang
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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