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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07010835
What this study is testing
What is YK012?
YK012 is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus (sle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18 to 75 years (inclusive) at screening, regardless of sex
- Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, with a confirmed SLE...
- Positive for anti-dsDNA antibody and/or antinuclear antibody (ANA) and/or anti-Smith antibody at screening, as determined using the local...
- Medium to high disease activity at screening, defined as: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥7
- Receiving stable background therapy at screening
You likely can't join if
- Known allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or any of its components
- Received any anti-CD19/CD20 therapy or any B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors...
- 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 to enrollment
- Used traditional Chinese medicines/herbal preparations for SLE treatment containing within 2 weeks prior to enrollment
- Received live or attenuated vaccines within 1 month prior to enrollment
See the full eligibility criteria
- Aged 18 to 75 years (inclusive) at screening, regardless of sex
- Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, with a confirmed SLE diagnosis for at least 24 weeks at screening
- Positive for anti-dsDNA antibody and/or antinuclear antibody (ANA) and/or anti-Smith antibody at screening, as determined using the local laboratory's reference ranges at the study site
- Medium to high disease activity at screening, defined as: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥7
- Receiving stable background therapy at screening
- Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures.
- Known allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or any of its components
- Received any anti-CD19/CD20 therapy or any B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors within 3 months or 5 half-lives prior to enrollment
- 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 to enrollment
- Used traditional Chinese medicines/herbal preparations for SLE treatment containing within 2 weeks prior to enrollment
- Received live or attenuated vaccines within 1 month prior to enrollment
- Has other autoimmune diseases, inflammatory joint diseases, or skin disorders (other than SLE) that may interfere with disease activity assessment
- History of malignancy within 5 years before screening, except for cured cases with no recurrence for at least 5 years, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, ductal carcinoma in...
- Clinically significant cardiovascular/cerebrovascular diseases within 6 months prior to screening
- Presence of QTcF interval prolongation on electrocardiogram (ECG)
- Presence of poorly controlled hypertension at screening
- History of non-SLE conditions requiring oral/intravenous/intramuscular/subcutaneous corticosteroid therapy (\>2 weeks) within 6 months prior to enrollment
- Active tuberculosis at screening or untreated latent tuberculosis
- History of solid organ or bone marrow transplantation
- Presence of active infections
- Lupus nephritis requiring protocol-prohibited medications as assessed by the investigator
- Uncontrolled lupus crisis within 8 weeks prior to screening
- History of central nervous system (CNS) disorders
- Presence of clinically unstable or uncontrolled medical conditions at screening
- Presence of clinically significant abnormal laboratory test results
- Presence of active viral infections (e.g., hepatitis B, hepatitis C, HIV, or active syphilis)
- Had major surgery within 4 weeks prior to enrollment or planned during study;
- Participation in other treatment clinical trials within 4 weeks prior to enrollment
- Pregnant or lactating women, or individuals with pregnancy plans during the study and within a specified period after treatment who are unwilling to use effective contraception
- Other conditions deemed by investigators to preclude study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.