Lupus Erythematosus, Systemic
Conditions
Keywords
Lupus Erythematosus, Systemic, Telitacicept
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).
Interventions
DRUGTelitacicept
160mg once a week for 48 weeks
DRUGStandard of Care
Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Sponsors
RemeGen Co., Ltd.
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of LLDAS in week 24 | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement in SLEDAI-2K | week 24 and 52 | Proportion of patients with SLEDAI-2K scores improvement ≥4 compared with baseline |
| Improvement in serological indices | week 24, 52 | Improvement in anti-dsDNA antibody titers, C3, C4, T cell and B cell subsets and IgG, IgA, IgM compared with baseline |
| Proportion of LLDAS in week 12 | 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 |
| Number of participants with Adverse Events | up to week 52 | 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 | up to week 52 | Proportion of patients suffer from SLE flare |
| Change in PGA | week 24, 52 | PGA: physician global assesment(0-3) |
Countries
China
Contacts
Primary ContactXiaomei Leng
Outcome results
None listed