Systemic Lupus Erythematosus (SLE)
Conditions
Brief summary
This study will evaluate the effect and safety of 626 in patients with SLE
Detailed description
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities. The purpose of this study is to demonstrate the clinical efficacy and safety of 626 added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with SLE.
Interventions
DRUG626
626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.
DRUGPlacebo
Placebo subcutaneous (SC) injection.
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Able to understand protocol requirements and sign a written ICF. * Male or female subjects aged 18-70 years when signing the ICF. * Body weight between 40 and 90 kg. * Diagnosed with SLE at least 6 months before the Screening Visit by a qualified physician，confirmed according to the 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE. * At screening, meet at least one of the following criteria: 1. Anti-nuclear antibody (ANA) titer ≥ 1:80; 2. Positive anti-dsDNA antibody.. * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 with clinical SLEDAI score ≥4 points at Screening and Baseline Visit . * Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
Exclusion criteria
* Study participant has a mixed connective tissue disease, and/or overlap syndrome of systemic lupus erythematosus (SLE) with systemic sclerosis. * Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition * Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. * History of cancer. * Active severe lupus nephritis present within 2 months prior to baseline. Or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2, or protein:creatinine ratio \>2.0 g/g.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events | During the 32- or 36-week study period | Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SLE Responder Index (SRI-4) | During the 20- or 24-week treatment period | Proportion of subjects achieving an SLE Responder Index (SRI-4) response |
| BILAG-based Combined Lupus Assessment (BICLA) Response | During the 20- or 24-week treatment period | Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response |
Other
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) | During the 32- or 36-week study period |
| Area under the Concentration-Time Curve up to the Last Measurable Concentration（AUC0-last） | During the 32- or 36-week study period |
| Time to Peak Concentration（Tmax ） | During the 32- or 36-week study period |
Countries
China
Contacts
Primary ContactQinghong Zhou
Outcome results
None listed