Actively Recruiting
The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE
Led by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Updated on 2025-11-26
198
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the effect and safety of 626 in patients with SLE
CONDITIONS
Official Title
The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand protocol requirements and sign a written informed consent form
- Male or female aged 18 to 70 years at consent
- Body weight between 40 and 90 kg
- Diagnosed with SLE at least 6 months before screening, confirmed by 2019 EULAR/ACR criteria
- At screening, positive for either ANA titer ≥ 1:80 or anti-dsDNA antibody
- SLE Disease Activity Index (SLEDAI-2K) score ≥ 6 with clinical score ≥ 4 at screening and baseline
- Currently receiving at least one standard SLE medication: oral corticosteroid, antimalarial, or immunosuppressive agent
You will not qualify if you...
- Presence of mixed connective tissue disease or overlap syndrome with systemic sclerosis
- Any medical or psychiatric condition that could compromise participation, including life-threatening illness
- Active Hepatitis B, Hepatitis C, or HIV infection at screening
- History of cancer
- Active severe lupus nephritis within 2 months prior to baseline or kidney function with eGFR <30 mL/min/1.73m2 or protein:creatinine ratio >2.0 g/g
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Q
Qinghong Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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