Phase 4 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 who have been diagnosed with systemic lupus erythematosus (SLE, also known as lupus) within the last 2 years, based on recognised 2019 international classification guidelines.
• People whose blood tests show certain lupus-related antibodies — specifically, a positive ANA result at a level of 1:80 or higher, and/or a positive anti-dsDNA antibody result confirmed on two separate occasions.
• People whose lupus is currently active, measured by a standard lupus activity scoring tool (SLEDAI-2K), either with a clinical score above 4, or a score of 1–4 combined with taking a steroid dose of 10mg per day or more.
• People whose lupus has not yet caused any permanent organ damage, confirmed at the screening visit using a standard damage scoring tool (SDI score of 0).
• People of any sex, provided that women who are able to become pregnant are not currently pregnant, not breastfeeding, and are using a highly effective method of contraception.
• People who are able to understand and sign an informed consent form agreeing to participate.

Who may not be able to join:

• People who have had lymphoma, leukaemia, or most other cancers within the past 5 years (certain skin cancers that have been fully removed with no spread for at least 3 years may be acceptable — confirm with trial site).
• People with serious, unstable, or poorly controlled medical conditions not caused by lupus (such as heart, lung, blood, gut, liver, kidney, neurological, psychiatric, or infectious conditions), or those with a planned surgery that the investigator believes could affect the study results or safety.
• People who have had a major organ transplant, a bone marrow or stem cell transplant, or a kidney transplant at any time.
• People currently taking ongoing suppressive treatment for chronic infections such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria.
• People who have had a serious infection requiring IV or IM antibiotics or hospitalisation within the past 60 days before the first dose of the study drug.
• People with confirmed active tuberculosis (TB) or untreated latent TB infection, unless certain completed treatment criteria are met (confirm with trial site).
• People with confirmed or suspected progressive multifocal leukoencephalopathy (PML), or unexplained new or worsening neurological symptoms.
• People with severe active lupus affecting the brain or central nervous system (such as seizures, psychosis, stroke, or brain inflammation) requiring treatment within 60 days before screening.
• People with active lupus kidney disease (lupus nephritis) that requires a type of intensive treatment not permitted by the trial protocol.
• People with significant depression or suicide risk, as assessed using a standard questionnaire (PHQ-9 score of 10 or above) where a mental health professional determines there is serious suicide risk, or people with any suicidal behaviour in the last 6 months or suicidal thoughts in the last 2 months (a mental health assessment is required in some cases — confirm with trial site).
• People known to have human anti-mouse antibodies, or who have had allergic reactions to diagnostic or therapeutic monoclonal antibody treatments in the past.
• People who have received a live or live-attenuated vaccine within 35 days before screening, or who plan to receive one during the study.
• People using oral steroids on an ongoing basis for a condition other than lupus (for example, asthma), though inhaled steroids are permitted.
• People currently taking certain lupus medications above specified doses, including azathioprine above 200mg/day, methotrexate above 25mg/week, mycophenolate mofetil above 2g/day, or other immunosuppressants above protocol-specified limits (confirm specific limits with trial site).
• People who have received certain injected or intravenous steroids within 6 weeks before the first dose, or who have been using more than one NSAID (anti-inflammatory painkiller) daily within 2 weeks before the first dose.
• People who have ever previously been treated with any of the following: a second-line immunosuppressant or anti-malarial medication (used because the first treatment did not work well enough); belimumab; anifrolumab; rituximab or other B-cell depleting therapies; anti-TNF therapies (such as adalimumab, etanercept, or infliximab); abatacept; anakinra; JAK inhibitors; intravenous cyclophosphamide; intravenous immunoglobulin; or plasmapheresis (confirm definitions of first- versus second-line therapy with trial site, as some medication changes due to side effects may be considered differently).
• People with a known primary immune deficiency, or very low levels of certain immune proteins (IgG below 400 mg/dL or IgA below 10 mg/dL) detected at screening.
• People with severely low levels of a type of white blood cell (neutrophils) — specifically an absolute neutrophil count below 1,000 per cubic millimetre.
• People with significantly elevated liver enzyme levels (ALT above twice the upper limit of normal) or elevated bilirubin levels (above 1.5 times the upper limit of normal), or active liver or bile duct disease, except in specific circumstances such as Gilbert's syndrome or stable chronic liver conditions (confirm with trial site).
• People with any other significantly abnormal blood test result that the investigator believes could affect how the study drug works or make participation unsafe.
• People who test positive for HIV.
• People with certain evidence of active or unresolved hepatitis B infection based on blood test results (confirm specific test combinations with trial site).
• People with a positive hepatitis C antibody test, unless a follow-up hepatitis C RNA test confirms the infection has fully resolved.
• People with a positive hepatitis C RNA test at screening or within 3 months before starting the study drug.
• People with a known sensitivity or allergy to the study drug, its components, or monoclonal antibodies that the investigator believes makes participation unsafe.
• People with current drug or alcohol dependence, or a history of drug or alcohol misuse or dependence within the past 364 days.
• People who are currently enrolled in, or have participated in, another clinical trial involving an experimental treatment within the past 3 months or 5 half-lives of that drug (whichever is longer).
• People who are unable to self-administer the study drug by a subcutaneous (under-the-skin) auto-injector at home and who do not have reliable help available to do so.

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