Phase 1 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 at the time of signing the consent form
• People weighing at least 45 kg with a body mass index (BMI) between 18 and 30
• People who have been formally diagnosed with Systemic Lupus Erythematosus (SLE) meeting at least 4 specific classification criteria, including at least one physical symptom or one immune system finding
• People whose SLE is moderately active, based on a specific disease activity scoring tool called SLEDAI (score between 6 and 12)
• People with active skin involvement from SLE that reaches certain levels on a skin scoring scale (CLASI-A score of 9 or more, and at least one skin lesion scoring 6 or more on a related scale)
• People who test positive for antinuclear antibodies at a certain level, and/or have elevated levels of a specific antibody linked to SLE
• People who have had SLE for at least 24 weeks at the time of signing the consent form
• People whose skin disease remains active despite having used topical and/or systemic steroid treatments and/or antimalarial medications for at least 3 months
• Women who could potentially become pregnant and who have a negative pregnancy test at the screening visit
• Men and women who could potentially become pregnant and who are willing to use two reliable forms of contraception from the time of signing the consent form, throughout the study, and for 6 months after the last dose of the study drug

Who may not be able to join:

• People with active lupus affecting the kidneys, or with significant chronic kidney disease based on certain laboratory measurements
• People with a history of lupus affecting the brain or nervous system, including conditions such as seizures, psychosis, confusion, meningitis, or related neurological conditions
• People with uncontrolled psychiatric conditions, severe depression, suicide attempts within the past year, or any mental illness that the study doctor considers a concern
• People with a history of antiphospholipid syndrome (a clotting disorder linked to lupus)
• People who have recently used certain medications that affect the immune system, including specific biological therapies, immunosuppressants, or high-dose steroids, within defined time periods before screening (confirm with trial site for specific timeframes and drug names)
• People whose blood test results fall outside certain ranges, including low counts of white blood cells, lymphocytes, or platelets, low haemoglobin, or abnormal kidney or liver markers
• People with uncontrolled high blood pressure despite using three blood pressure medications
• People with significant heart conditions, including severe angina, recent heart attack within 6 months, advanced heart failure, or serious heart rhythm problems not controlled by treatment
• People with moderate to severe asthma, advanced chronic obstructive pulmonary disease (COPD), a history of severe allergic swelling (angioedema), or serious breathing problems
• People with other active skin conditions unrelated to SLE (such as psoriasis, rosacea, or local skin infections) that may affect how the study results are assessed
• People with other ongoing conditions requiring treatment with systemic (oral, injected, or rectal) steroids, such as inflammatory bowel disease or acute eye inflammation
• People with a history of serious herpes infections affecting the brain, eyes, or spread widely through the body
• People diagnosed within the past 3 months with chickenpox, cytomegalovirus, glandular fever (infectious mononucleosis), shingles, genital herpes, or herpetic mouth infection
• People with a current or past diagnosis of severe immune deficiency of any cause
• People with a current, past, or latent tuberculosis infection, or who have close ongoing contact with someone who has active tuberculosis
• People with any other chronic infection that the study doctor believes could increase the risk of complications
• People who have had a serious active infection requiring hospitalisation or intravenous antibiotics or antifungal treatment within 8 weeks before signing the consent form
• People who have used systemic antibiotic, antifungal, or antiprotozoal treatments within 8 weeks before signing the consent form
• People who have received or are scheduled to receive any live or non-live vaccine within 1 month before screening, during the study, or within 4 months after the last study dose
• People with confirmed HIV infection, hepatitis B infection, or active hepatitis C infection
• People who have had COVID-19 or major surgery within 4 weeks before signing the consent form, or who have major surgery planned during the study period
• People currently participating in another clinical trial, or who have participated in one within 3 months before signing the consent form
• People with other significant health conditions that, in the study doctor's opinion, could affect SLE, interfere with assessments, or create unacceptable risks
• People with a history of blood cancers or solid tumours (including certain skin cancers) that have been in remission for less than 5 years, except for cervical cancer in situ that has been fully treated
• People for whom intravenous (IV) drug administration is not possible
• People with a known allergy or hypersensitivity to any component of the study drugs, or a history of severe allergic reactions to similar types of antibody-based medicines
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose; men who are planning to father a child during this period

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