Phase 1 Rheumatoid Arthritis 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 at the time of signing the consent form.
• People diagnosed with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA) — for the first part of the trial.
• People diagnosed with SLE, RA, idiopathic inflammatory myopathies (a type of muscle inflammation condition), or Sjögren's disease — for the second part of the trial.
• People with a body weight of at least 45 kg and a body mass index (BMI) between 18 and 35 (confirm with trial site if unsure how to calculate this).
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or are using a highly effective form of contraception (with a failure rate of less than 1%) starting at least 28 days before the study drug and continuing for at least 28 weeks after the first dose.
• Women who could become pregnant must have a negative pregnancy test within 24 hours before the first dose of the study drug.
• People who are willing and able to attend hospital stays, clinic visits, and all scheduled study appointments as outlined in the study plan.

Who may not be able to join:

• People experiencing a sudden, severe flare of their autoimmune condition just before or during the screening period that needs immediate treatment or is likely to require medications not permitted in the study.
• People with known significant allergies or sensitivities to humanised monoclonal antibodies (a type of laboratory-made protein) or to any ingredients in the study drug.
• People with a history of severe drug allergies, intolerance to topical steroid creams, or serious skin reactions to medications (such as toxic epidermal necrolysis or exfoliative dermatitis).
• People with significant unstable or uncontrolled ongoing health conditions unrelated to their autoimmune disease — such as heart, lung, blood, digestive, liver, kidney, or infection-related conditions — or a planned surgery that the study doctor believes could affect the results or pose an unacceptable risk.
• People with other abnormal lab results that the study doctor believes could significantly affect how the body processes the study drug or interfere with interpreting the study results.
• People with a diagnosis of a primary or acquired immune deficiency condition, except for selective IgA deficiency.
• People with an active infection within 2 weeks before the first dose, or who are currently receiving systemic antibiotic, antiviral, or antifungal treatment (topical treatments for fungal nail infections are permitted).
• People with a history of significant recurring or chronic infections (minor localised infections may be acceptable — confirm with trial site).
• People who have had an opportunistic infection (a serious infection that occurs when the immune system is weakened) within the past 3 years (note: uncomplicated shingles, localised cold sores, and oral thrush are not counted for this purpose).
• People who have had shingles within 3 months before screening.
• People who were hospitalised or required injected antibiotics for a serious infection, if the last dose of antibiotics or hospital discharge was within 30 days of the first study dose.
• People with a history of a serious infection linked to low levels of immunoglobulins (proteins that help fight infection) in the blood.
• People with evidence of active or latent tuberculosis (TB), based on medical history, physical examination, chest X-ray, or a positive TB blood test.
• People who have had confirmed progressive multifocal leukoencephalopathy (a serious brain infection) within the past 12 months, or who have unexplained or worsening neurological symptoms.
• People with a confirmed diagnosis of, or positive test for, HIV at screening.
• People with a significant history of neurological or psychiatric conditions, including epilepsy, dementia, major depression that could interfere with the study, increased suicide risk as assessed by the study doctor, or a history of bleeding in the brain.
• People with a current or recent history (within 5 years) of cancer, except for certain treated skin cancers or treated cervical conditions with no signs of spread for at least 3 years (confirm with trial site).
• People who have had a bone marrow or solid organ transplant.
• People who have received a live or live-attenuated vaccine within 30 days before screening, or who plan to receive one during the study.
• People who have received certain medications within specific time periods before the first study dose, including (but not limited to):
  • Injected corticosteroids (steroids given into a vein or muscle) within 5 weeks
  • Certain immune-targeting therapies such as CAR-T cell treatment (at any time), B-cell depleting agents within 4 months, belimumab or anifrolumab within 8 weeks, cyclophosphamide within 12 weeks, certain biologic medicines within 4–8 weeks, certain small molecule inhibitors (such as JAK inhibitors or TYK2 inhibitors) within 4 weeks, intravenous immunoglobulin within 8 weeks, or plasmapheresis within 8 weeks (confirm specific medication timelines with trial site)
• People who are currently enrolled in, or have recently participated in, another clinical trial involving an investigational treatment within 3 months or 5 half-lives of that drug before the first study dose (whichever is longer).
• People who cannot take the preventive or rescue medications used to manage potential side effects of the study drug (such as steroids, antihistamines, fever-reducing medications, or tocilizumab).
• People with a current or recent history (within 12 months) of drug or alcohol dependence or abuse.
• People with certain abnormal liver-related blood test results above specified thresholds (confirm with trial site).
• People with a current or long-term history of liver disease or known liver or bile duct abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
• People who test positive for hepatitis B at screening or within 3 months before the first dose.
• People who test positive for hepatitis C antibodies or hepatitis C RNA at screening or within 3 months before the first dose, unless a follow-up test confirms the infection has fully resolved.
• People with a prolonged heart rhythm measurement (QTc interval) on an ECG above the specified threshold, as determined by the study doctor (confirm with trial site).

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