Actively Recruiting
Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus
Led by Excyte Biopharma Ltd · Updated on 2026-02-05
189
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE).
CONDITIONS
Official Title
Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years (inclusive) at screening, regardless of sex
- Meet the 2019 EULAR/ACR classification criteria for SLE with a confirmed diagnosis for at least 24 weeks
- Positive for anti-dsDNA antibody and/or antinuclear antibody (ANA) and/or anti-Smith antibody at screening
- Medium to high disease activity at screening with a SLEDAI-2K score of 7 or higher
- Receiving stable background therapy at screening
- Able to understand, voluntarily participate, provide written informed consent, and comply with study procedures
You will not qualify if you...
- Allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or its components
- Received anti-CD19/CD20 therapy or B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors within 3 months or 5 half-lives prior
- Received TNF inhibitors, interleukin receptor blockers, other small molecules or biologics within 3 months or 5 half-lives prior to enrollment
- Received intravenous immunoglobulins or plasmapheresis within 3 months prior
- Used traditional Chinese medicines/herbal preparations for SLE within 2 weeks prior
- Received live or attenuated vaccines within 1 month prior
- Other autoimmune diseases, inflammatory joint diseases, or skin disorders that may interfere with disease assessment
- History of malignancy within 5 years except certain cured cancers
- Significant cardiovascular/cerebrovascular diseases within 6 months prior
- QTcF interval prolongation on ECG
- Poorly controlled hypertension at screening
- History of non-SLE conditions requiring corticosteroid therapy over 2 weeks within 6 months prior
- Active or untreated latent tuberculosis
- History of solid organ or bone marrow transplantation
- Presence of active infections
- Lupus nephritis requiring prohibited medications
- Uncontrolled lupus crisis within 8 weeks prior
- History of central nervous system disorders
- Clinically unstable or uncontrolled medical conditions
- Significant abnormal lab results
- Active viral infections such as hepatitis B, hepatitis C, HIV, or active syphilis
- Major surgery within 4 weeks prior or planned during study
- Participation in other interventional trials within 4 weeks prior
- Pregnant or lactating women, or unwilling to use contraception during and after study
- Other conditions that may prevent participation as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
X
Xiaofeng Zeng, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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