Actively Recruiting
JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)
Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2024-11-05
20
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)
CONDITIONS
Official Title
JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with SLE according to 2019 EULAR/ACR or 2012 SLICC criteria
- Treated with glucocorticoids plus immunosuppressants and/or biologics for at least 2 months prior to screening with stable dose >2 weeks and active disease
- Positive anti-nuclear antibody (ANA), anti-ds-DNA antibody, or anti-Smith antibody at screening
- Screening SLEDAI-2K score >6 and clinical SLEDAI-2K score 64
- BILAG2004 score with 651 organ system Grade A or 652 organ systems Grade B disorders
- Physician's General Assessment (PGA) score 651.0 (0-3 scale) at screening
You will not qualify if you...
- Other autoimmune diseases needing systemic therapy
- Uncontrolled lupus crisis within 8 weeks before screening, including severe lupus nephritis, neuropsychiatric lupus, haemolytic anaemia, thrombocytopenia, granulocyte deficiency, cardiac damage, pneumonitis, hepatitis, vasculitis
- Significant CNS disease not due to lupus, like stroke, epilepsy, dementia, psychosis
- History or plans for bone marrow, stem cell, or solid organ transplantation
- Significant cardiovascular dysfunction in past 12 months, such as advanced heart failure, myocardial infarction, unstable angina, arrhythmias
- Significant pulmonary or cardiac problems like pericarditis or pleural effusion unsuitable for study
- Severe asthma or COPD excluded; mild/moderate stable allowed
- History of cancer within 5 years except certain treated or in situ cancers
- Pregnant or breastfeeding women
- History of recurrent severe infections needing hospitalization
- Active infection needing systemic treatment within 2 weeks prior to clearance
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Recent live attenuated vaccine within 4 weeks before clearance
- Recent high-dose corticosteroids or unable to taper to 6410 mg/day before clearance
- Inability to adjust background therapy before clearance
- Receiving or expected to need renal replacement therapy within 3 months
- History of drug or alcohol abuse within 1 year
- Suicidal thoughts or behavior within recent months posing significant risk
- Use of another study drug within 4 weeks or 5 half-lives before screening
- History of severe allergic reaction to study drug or components
- Any condition judged by investigator to affect study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
920th HJointLogistics
Kunming, Yunnan, China
Actively Recruiting
Research Team
S
Sanbin Wang, Doctor
CONTACT
L
Lin Liu, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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