A Study of Telitacicept in Lupus Nephritis

Sponsor

RemeGen Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05680480

Collaborator

(none)

120

Enrollment

Locations

Arms

22.1

Anticipated Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Biological: Telitacicept 240 mg Biological: Telitacicept 160 mg Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Complete Renal Response (CRR) [Week 48]
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.

Secondary Outcome Measures

Percentage of participants with Partial Renal Response (PRR) [Week 24 and Week 48]
PRR is defined as 24-hour urinary protein: creatinine ratio reduced by 50% compared to baseline value.
Incidence of AE, SAE [Up to Week 48]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main Inclusion Criteria:

Males or females aged 18-75 years of age, inclusive.
Diagnosis of systemic lupus erythematosus according to American College of Rheumatology criteria (1997).
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.
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.
Active renal disease at screening requiring induction therapy with high dose corticosteroids (HDCS) with mycophenolate mofetil (MMF) or other oral forms of mycophenolate.
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.
Able to understand the requirements of the study and provide written informed consent.

Main Exclusion Criteria:

Known hypersensitivity or contraindication to any drug products they plan to receive (e.g., MMF, corticosteroids).
History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
Received any of the following therapies:
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;
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;
Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
Received plasma separation or plasma exchange during the 6 weeks prior to screening;
Subjects who required dialysis within 1 year prior to screening.
Received a live vaccine or live-attenuated vaccine within 4 weeks prior to screening or expected to vaccinate during the study.
Received BCG Vaccine within 1 year prior to screening.
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).
History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant or are due to receive transplantation.
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.
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.
History of drug or alcohol abuse or dependence within 364 days prior to baseline (Day 1).
Nursing or pregnant female, or male or female who prepared for parenthood during the study.
History of malignant tumors within the last 5 years, excluding adequately treated skin cancer (basal or squamous cell) or carcinoma in situ of cervix.
Have acute or chronic infection requiring treatment.
HIV positive.
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.
Hepatitis C antibody positive.
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.
eGFR<30 mL/min/1.73 m2 using CKD-EPI.
Renal biopsy showed 50% glomerulosclerosis.
Subjects who in the opinion of the investigator are not suitable to participate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	Hefei	Anhui	China	230001
2	Peking University People's Hospital	Beijing	Beijing	China	100044
3	The First Hospital Affiliated to the Army Medical University	Chongqing	Chongqing	China	400038
4	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China	361003
5	Zhongshan Hospital Affiliated to Xiamen University	Xiamen	Fujian	China	361004
6	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510000
7	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510080
8	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510630
9	Liuzhou Workers' Hospital	Liuzhou	Guangxi	China	545005
10	Guizhou Provincial People's Hospital	Guiyang	Guizhou	China	550002
11	Affiliated Hospital of Hebei University	Baoding	Hebei	China	071000
12	Handan First Hospital	Handan	Hebei	China	056002
13	Hebei General Hospital	Shijiazhuang	Hebei	China	050051
14	The Third Affiliated Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050051
15	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
16	Xiangya Hospital of Central South University	Changsha	Hunan	China	410008
17	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China	410013
18	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology	Baotou	Inner Mongolia	China	014017
19	Zhongda Hospital Southeast University	Nanjing	Jiangsu	China	210009
20	Wuxi People's Hospital	Wuxi	Jiangsu	China	214023
21	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi	China	330006
22	The First Hospital of Jilin University	Chang chun	Jilin	China	130021
23	The Second Hospital of Jilin University	Changchun	Jilin	China	130042
24	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110004
25	General Hospital of Northern Theater Command of the Chinese People's Liberation Army	Shenyang	Liaoning	China	110015
26	The Affiliated Hospital of Qinghai University	Xining	Qinghai	China	810001
27	Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710004
28	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012
29	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China	266000
30	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai	China	200040
31	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200127
32	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030001
33	Shanxi Provincial People's Hospital	Taiyuan	Shanxi	China	030012
34	Shanxi Bethune Hospital	Taiyuan	Shanxi	China	030032
35	West China Hospital Sichuan University	Chengdu	Sichuan	China	610041
36	People's Hospital of Sichuan Province	Chengdu	Sichuan	China	610072
37	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052
38	Tianjin Medical University Second Hospital	Tianjin	Tianjin	China	300211
39	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang	China	830001
40	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China	830054
41	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009
42	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	310014
43	Taizhou Hospital of Zhejiang Province	Linhai	Zhejiang	China	317000
44	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China	325000
45	The Fourth Affiliated Hospital, Zhejiang University School of Medicine	Yiwu	Zhejiang	China	322000