Early Phase 1 Lupus Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older who are able to give informed consent to take part.
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE) and meet the recognised classification criteria for this condition.
• People with active SLE that is not primarily affecting the kidneys, who have already tried at least one disease-modifying medication (not counting hydroxychloroquine or steroids) without enough improvement, OR people with active lupus kidney disease (lupus nephritis) that has not responded adequately to standard treatment after at least 3 months. Active disease is measured using specific medical scores and laboratory tests (confirm with trial site for full details).
• Women who could become pregnant must agree to use a highly effective form of contraception during the trial and for at least 120 days after the last dose of the study drug.
• Men whose partners could become pregnant must agree to use condom-based contraception during the trial and for at least 120 days after the last dose of the study drug.
• All participants must agree not to donate eggs or sperm during the trial and for at least 120 days after the last dose of the study drug.

Who may not be able to join:

• People with another serious uncontrolled medical condition (such as severe asthma, certain lung diseases, or severe obesity) that the trial doctor considers would make participation unsafe or affect the trial results.
• People with active SLE affecting the brain or nervous system in a way that significantly affects thinking or understanding, making it difficult to consent or follow the trial requirements.
• People who need ongoing systemic steroid medication (taken by mouth, injection, or rectally) to manage another condition such as asthma or inflammatory bowel disease.
• People with a significant active infection (viral, bacterial, or fungal), or who were hospitalised for an infection or treated with intravenous antibiotics within the past 4 weeks, or who completed a course of oral antibiotics within the past 2 weeks.
• People who test positive for HIV, hepatitis B, or hepatitis C at the screening visit.
• People with a current or past diagnosis of active tuberculosis (TB), or untreated latent (inactive) TB identified by a positive QuantiFERON test at screening.
• People with a history of cancer (blood or solid tumour) in the past 10 years, with limited exceptions for certain minor treated skin cancers or treated cervical abnormalities (confirm with trial site for full details).
• People who received a live or live-attenuated vaccine within 1 month before or during the screening period.
• People who started or changed the dose of certain blood pressure medications (ACE inhibitors or angiotensin receptor blockers) within 2 weeks before or during the screening period.
• People currently being treated with Voclosporin or Cyclophosphamide at the time of screening.
• People who have taken part in another clinical trial or used an investigational drug within the past 3 months or 5 half-lives of that drug (whichever is longer) before screening.
• People with significantly abnormal blood test results at screening, unless those results are clearly due to active SLE — specific thresholds apply to liver enzymes, bilirubin, haemoglobin, white blood cells, neutrophils, and platelets (confirm with trial site for full details).
• People with significant abnormalities found on recent chest imaging (such as X-ray, CT, or MRI), including signs of active TB or certain lung conditions, based on the trial doctor's assessment. Imaging must have been done within 3 months before or during screening.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test within 14 days of starting the trial.
• People who are unwilling or unable to follow the contraception requirements described above.

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