Back to resultsEfficacy and Safety of Telitacicept in Early SLE
Primary Purpose
Lupus Erythematosus, Systemic
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Telitacicept
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Lupus Erythematosus, Systemic, Telitacicept
Eligibility Criteria
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
Sites / Locations
- Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting
- Peking University Third Hospital
- Fuyang People's Hospital
- Guangdong Provincial People's Hospital
- Nanfang Hospital, Southern Medical University
- Qilu Hospital of Shandong University
- the First People's Hospital of Yunnan Province
- The Second Affiliated Hospital of Lanzhou University
- The Affiliated Hospital of Nantong University
- the Affiliated Hospital of Qingdao University
- The Second Hospital of Hebei Medical University
- The First Affiliated Hospital of Soochow University
- Shanxi Baiqiuen Hospital
- First Affiliated Hospital of Xinjiang Medical University
- Weifang People's Hospital
- Tongji Hospital, Tongji Medical College,
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Wuxi Second People's Hospital
- the First Affiliated Hospital of Xi'an Jiaotong University
- The First Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment group
Control group
Arm Description
Standard of care plus Telitacicept 160 mg sc per week; after week 12, the dose can be reduced to 80 mg per week due to safety considerations.
Standard of care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Improvement in SLEDAI-2K
Proportion of patients with SLEDAI-2K scores improvement ≥4 compared with baseline
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
Change in PGA
PGA: physician global assesment(0-3)
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.
Disease flare
Proportion of patients suffer from SLE flare
Full Information
NCT ID
NCT05899907
First Posted
March 26, 2023
Last Updated
June 1, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
RemeGen Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05899907
Brief Title
Efficacy and Safety of Telitacicept in Early SLE
Official Title
A Study of Telitacicept in the Treatment of Early Stage Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
RemeGen Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Lupus Erythematosus, Systemic, Telitacicept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Standard of care plus Telitacicept 160 mg sc per week; after week 12, the dose can be reduced to 80 mg per week due to safety considerations.
Arm Title
Control group
Arm Type
Other
Arm Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Telitacicept
Other Intervention Name(s)
RC18
Intervention Description
160mg once a week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Primary Outcome Measure Information:
Title
Proportion of LLDAS in week 24
Description
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
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Proportion of LLDAS in week 12
Description
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
Time Frame
week 12
Title
Improvement in SLEDAI-2K
Description
Proportion of patients with SLEDAI-2K scores improvement ≥4 compared with baseline
Time Frame
week 24 and 52
Title
Improvement in serological indices
Description
Improvement in anti-dsDNA antibody titers, C3, C4, T cell and B cell subsets and IgG, IgA, IgM compared with baseline
Time Frame
week 24, 52
Title
Change in PGA
Description
PGA: physician global assesment(0-3)
Time Frame
week 24, 52
Title
Number of participants with Adverse Events
Description
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.
Time Frame
up to week 52
Title
Disease flare
Description
Proportion of patients suffer from SLE flare
Time Frame
up to week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei Leng
Phone
+8613681057089
Email
lpumch@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaomei Leng
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei Leng
Phone
+8613681057089
Email
lpumch@126.com
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fuyang People's Hospital
City
Fuyang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanfang Hospital, Southern Medical University
City
Guanzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
the First People's Hospital of Yunnan Province
City
Kunming
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital of Lanzhou University
City
Lanzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Affiliated Hospital of Nantong University
City
Nantong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
the Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanxi Baiqiuen Hospital
City
Taiyuan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Weifang People's Hospital
City
Weifang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tongji Hospital, Tongji Medical College,
City
Wuhan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Wuxi Second People's Hospital
City
Wuxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
the First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhenzhou
Country
China
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy and Safety of Telitacicept in Early SLE
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