Phase 2 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 75 years old (inclusive) at the time of screening
• You have been officially diagnosed with Systemic Lupus Erythematosus (SLE/Lupus) for at least 24 weeks, confirmed using recognised medical guidelines
• Certain specific lupus-related antibodies show up in your blood tests at screening
• Your lupus is considered moderately to highly active at the time of screening, based on a standard lupus activity scoring system
• You are already on a stable lupus treatment plan at the time of screening
• You are able to understand the trial, agree to take part voluntarily by signing a consent form, and are able to attend all required visits and follow the study schedule

Who may not be able to join:

• You have a known allergy or sensitivity to monoclonal antibody treatments, human immunoglobulin products, or any ingredient in the study drug
• You have received certain B-cell targeting therapies (such as anti-CD19 or anti-CD20 treatments) within the past 6 months, or certain other biological therapies within the past 3 months or a specified number of half-lives (confirm with trial site)
• You have received certain other biologic or immune-modifying treatments, such as TNF inhibitors or interleukin blockers, within the past 3 months or a specified number of half-lives (confirm with trial site)
• You have received intravenous immunoglobulin infusions or plasma exchange treatment within the past 3 months
• You have used traditional Chinese medicines or herbal preparations for lupus within the past 2 weeks
• You have received any live or weakened (attenuated) vaccines within the past month
• You have another autoimmune condition, inflammatory joint disease, or skin condition (separate from lupus) that could affect how your lupus activity is measured
• You have had a cancer diagnosis within the past 5 years, unless it was a specific type that was fully treated with no return for at least 5 years (such as certain skin cancers, early-stage cervical, breast, or thyroid cancers) (confirm with trial site)
• You have had a significant heart or stroke-related event within the past 6 months
• A heart tracing (ECG) shows an abnormality in your heart's electrical rhythm known as QTcF interval prolongation (confirm with trial site)
• You have high blood pressure that is not well controlled at the time of screening
• You have needed steroid treatment (by mouth or injection) for a condition other than lupus for more than 2 weeks within the past 6 months
• You have active tuberculosis (TB) at screening, or untreated latent (inactive) TB
• You have had a solid organ transplant (such as a kidney or liver) or a bone marrow transplant at any point
• You currently have an active infection of any kind
• You have lupus affecting your kidneys in a way that requires treatments not allowed in this trial, as judged by the study doctor
• You experienced a severe lupus flare or crisis within the past 8 weeks before screening
• You have a history of conditions affecting your brain or central nervous system (confirm with trial site)
• You have other serious or unstable health conditions at the time of screening
• Your routine blood or urine tests show significantly abnormal results at screening (confirm with trial site)
• You have an active viral infection such as Hepatitis B, Hepatitis C, HIV, or active syphilis
• You have had major surgery within the past 4 weeks, or have planned major surgery during the study
• You are currently taking part in another clinical trial that involves a treatment intervention, or have done so within the past 4 weeks
• You are pregnant, breastfeeding, planning to become pregnant during the study or for a set period after treatment, or are unwilling to use effective contraception during that time
• The study doctor believes there is any other reason that would make it unsafe or unsuitable for you to take part

Important: Always verify eligibility with the trial site directly before applying.