Phase 3 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:

• People aged 18 to 70 years old, of any sex
• People who have been formally diagnosed with Systemic Lupus Erythematosus (SLE/lupus) by a rheumatologist
• People whose blood test results at the screening visit show certain lupus-related markers (ANA, Anti-dsDNA, or Anti-Smith antibodies) confirmed by the trial's central laboratory
• People who are currently taking antimalarial medications (such as hydroxychloroquine), with or without oral corticosteroids, as their standard lupus treatment
• People whose lupus disease activity meets a certain level of severity at screening and at the start of the trial, based on a scoring system called SLEDAI-2K, or who are taking a higher dose of corticosteroids (confirm with trial site)
• People who weigh at least 40 kg (approximately 88 pounds)
• People who test negative for pregnancy at the screening visit (for females)
• People who have had a normal HPV test result within the two years before the trial start date
• People who are willing and able to attend all required study visits, complete all study procedures, and fill in patient questionnaires
• People who are willing to avoid any other experimental treatments during the study

Who may not be able to join:

• People who have, or have a history of, a significant blood vessel inflammation condition (vasculitis) that is not related to their lupus
• People with antiphospholipid antibody syndrome where that condition is the main or only feature of their lupus (confirm with trial site)
• People who have had a serious blood clot event (such as a pulmonary embolism, stroke, or deep vein thrombosis) or an unexplained pregnancy loss within the year before screening
• People who have a history of a severe form of antiphospholipid syndrome called catastrophic antiphospholipid syndrome, or a type of large blood clot called a saddle embolism
• People who have had three or more unexplained consecutive pregnancy losses
• People who have had thoughts of suicide in the past 6 months, any suicidal behaviour in the past 12 months, or a history of repeated suicidal behaviour at any point in their lifetime
• People who currently have severe or unstable lupus affecting the brain or nervous system that is not being adequately managed by standard treatment
• People who currently have severe active lupus-related kidney disease that is not being adequately managed by standard treatment
• People who currently have catastrophic antiphospholipid syndrome
• People who have a history of repeated serious infections requiring hospitalisation and intravenous (IV) antibiotics (for example, three or more of the same type of infection within the past year)
• People with a known history of a primary immune deficiency, who have had their spleen removed, who have an underlying condition that makes them more prone to infections, or who test positive for HIV at screening
• People who test positive for hepatitis B
• People who have had a cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not fully resolved at least 12 weeks before signing the consent form
• People who have had a serious opportunistic infection requiring hospitalisation or IV treatment within the three years before the trial start date
• People who have had a significant ongoing infection (excluding chronic nail infections) within the 8 weeks before signing the consent form
• People who have had a severe case of shingles (herpes zoster) or repeated episodes of shingles
• People who have a current or past cancer diagnosis, except for certain treated skin cancers or treated cervical cancer in situ that meets specific time and treatment requirements (confirm with trial site)
• People who have previously received any lupus treatments other than antimalarials and oral corticosteroids
• People who have a known allergy or reaction to any ingredient in the study medication, or a history of severe allergic reaction (anaphylaxis) to human immunoglobulin therapies or human proteins or monoclonal antibodies
• People who have received a live or weakened live vaccine within 8 weeks before signing the consent form
• People who have received a blood transfusion or blood products (other than albumin)
• People who have previously participated in more than two investigational (experimental) treatment studies for lupus since their diagnosis
• People who have taken any experimental medication (whether a small molecule or a biologic) within 4 weeks or 5 half-lives before signing the consent form, whichever is the longer period
• People who are currently enrolled in another clinical trial involving an experimental treatment
• People whose laboratory (blood or urine) test results fall outside the ranges specified in the trial protocol (confirm with trial site)
• People who have other autoimmune diseases such as multiple sclerosis, psoriasis, or inflammatory bowel disease
• People who have lupus overlap syndromes such as scleroderma or mixed connective tissue disease
• People who have a non-lupus condition that the treating doctor believes is likely to require additional steroid treatment during the study (for example, asthma)
• People who have any other condition that the trial team determines could interfere with the study results or put the person at safety risk
• Females who are currently pregnant, breastfeeding, or planning to become pregnant or begin breastfeeding at any time from the start of screening until 16 weeks after their last dose of the study medication
• Females who have had a miscarriage, abortion, stillbirth, or live birth within 4 weeks before signing the consent form
• People who currently have, or within the past year have had, problems with alcohol, drug, or chemical misuse
• People who have had major surgery within the 8 weeks before signing the consent form, or who have major elective surgery planned during the study period

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