Efficacy and Safety of Telitacicept in Early SLE

Lupus Erythematosus, Systemic Clinical Trial

Official title:

A Study of Telitacicept in the Treatment of Early Stage Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899907
• Other study ID #: PUMCH-HS3345D
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2023
• Source: Peking Union Medical College Hospital
• Contact: Xiaomei Leng
• Phone: +8613681057089
• Email: lpumch[@]126.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 early stage of SLE .

Description:

This is a phase 4, multicentre, randomised, double-blind, open-labeled study to evaluate the efficacy and safety of telitacicept in adult subjects with active early stage of SLE (disease duration less than 2 years).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria

• 18-65 years of age

• body weight 45-90kg

• antinuclear antibody titers =1:80, and/ or anti-double-stranded DNA antibodies

• SLEDAI-2K score =8 scores

• Disease duration less than 2 years (defined as the duration between the first appearance of any symptom/sign attributed to SLE and baseline)

• A stantard therapy for at least 30d for patients who are not treatment-naive

• Negative pregnancy test for child-bearing women at screening and baseline

• Provide written informed consent

Exclusion Criteria:

• Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al

• Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment

• severe lupus nephritis: 24hUP more than 6g, serum creatinine > 221umol/L

• 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)

• Abnormal liver function (ALT or AST is 2 times higher than normal)

• Baseline IgG below the lower limit of the normal range

• Pregnancy or breastfeeding women

• Have a history of malignant tumors

• Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis)

• Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV

• Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics

• Active hemorrhage or peptic ulcer

• With other concommitant autoimmune disease;

• Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization

• Receipt of IVIG within 28 days before randomization

• Receipt of TNF inhibitor, IL-1R inhibitor or plasma exchange therapy within 90 days before randomization

• Participated in other drugs clinical trials within 4 weeks.

• Receipt of live vaccine within 4 weeks before randomization

• Receipt of COVID-19 vaccine within 4 weeks before randomization

• Subjects who in the opinion of the investigator are not suitable to participate

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• Telitacicept
160mg once a week for 48 weeks
• Standard of Care
Steroid(=1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing	Beijing
China	Peking University Third Hospital	Beijing
China	Fuyang People's Hospital	Fuyang
China	Guangdong Provincial People's Hospital	Guangzhou
China	Nanfang Hospital, Southern Medical University	Guanzhou
China	Qilu Hospital of Shandong University	Jinan
China	the First People's Hospital of Yunnan Province	Kunming
China	The Second Affiliated Hospital of Lanzhou University	Lanzhou
China	The Affiliated Hospital of Nantong University	Nantong
China	the Affiliated Hospital of Qingdao University	Qingdao
China	The Second Hospital of Hebei Medical University	Shijiazhuang
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Shanxi Baiqiuen Hospital	Taiyuan
China	First Affiliated Hospital of Xinjiang Medical University	Urumqi
China	Weifang People's Hospital	Weifang
China	Tongji Hospital, Tongji Medical College,	Wuhan
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	Wuxi Second People's Hospital	Wuxi
China	the First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	The First Affiliated Hospital of Zhengzhou University	Zhenzhou

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of LLDAS in week 24	Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K =4, no activity in any major organ, no new disease activity feature, PGA =1, prednisone =7.5 mg/day, and allowance for maintenance of IS and antimalarials	week 24
Secondary	Proportion of LLDAS in week 12	Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K =4, no activity in any major organ, no new disease activity feature, PGA =1, prednisone =7.5 mg/day, and allowance for maintenance of IS and antimalarials	week 12
Secondary	Improvement in SLEDAI-2K	Proportion of patients with SLEDAI-2K scores improvement =4 compared with baseline	week 24 and 52
Secondary	Improvement in serological indices	Improvement in anti-dsDNA antibody titers, C3, C4, T cell and B cell subsets and IgG, IgA, IgM compared with baseline	week 24, 52
Secondary	Change in PGA	PGA: physician global assesment(0-3)	week 24, 52
Secondary	Number of participants with Adverse Events	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 52
Secondary	Disease flare	Proportion of patients suffer from SLE flare	up to week 52