Actively Recruiting
A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-05-11
248
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, double-blind, multi-center, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in adult participants with active Systemic Lupus Erythematosus (SLE), including a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and a 12-week safety follow-up period. Approximately 245 SLE patients will be included.
CONDITIONS
Official Title
A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 through 65 years at screening
- Body Mass Index (BMI) of 18 kg/m² or higher at screening
- Diagnosed with Systemic Lupus Erythematosus for at least 6 months before screening
- Positive ANA at 1:80 or higher, or elevated anti-dsDNA or anti-Sm antibodies at screening
- High disease activity at screening and baseline
- Receiving stable doses of oral corticosteroids, antimalarial drugs, or conventional immunosuppressants
- Understand the study, possible side effects, and have signed informed consent
- Agree to use contraception as specified if fertile or have a partner of childbearing potential
You will not qualify if you...
- Severe lupus-related kidney disease or kidney damage
- Active neuropsychiatric SLE within 6 months before screening
- Other autoimmune or inflammatory diseases that interfere with study results
- Catastrophic or severe antiphospholipid syndrome within 12 months before screening
- History of progressive multifocal leukoencephalopathy (PML) or organ transplantation
- Previous gene therapy or recent specific biologic or immunosuppressive treatments
- Recent corticosteroid injections or live vaccine use before randomization
- Malignant tumors or poorly controlled serious chronic diseases
- Certain infections or immune deficiencies including herpes zoster, tuberculosis, or HIV
- Pregnant or lactating women
- History of alcohol or drug abuse within 1 year before screening
- Allergies to study drug components
- Major surgery within 3 months before screening or planned during the trial
- Any other condition deemed unsafe or unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
2
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
S
Su Zhang, M.M
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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