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 who have been diagnosed with Systemic Lupus Erythematosus (SLE) and/or Rheumatoid Arthritis (RA), confirmed using standard international classification guidelines.
• People whose disease is currently active enough to meet specific scoring thresholds measured at the screening visit (confirm with trial site for exact scores relevant to each condition).
• For SLE: People who have had specific antibodies detected in past blood tests, including ANA at a certain level, plus at least one other lupus-related antibody.
• For SLE: People whose lupus has not responded well enough to steroid treatment and at least one other listed medication (such as mycophenolate, azathioprine, rituximab, or others) taken for at least 12 weeks.
• For RA: People with moderate-to-severe disease activity based on a standard joint assessment score above 3.2 at screening.
• For RA: People whose condition has not responded well enough, or who could not tolerate, at least two disease-modifying drugs — including at least one biologic or targeted synthetic drug — taken for a minimum of 12 weeks.
• For RA: People who have at least 6 tender joints and at least 6 swollen joints at the screening visit.
• For RA: People who have been taking methotrexate at a stable dose for at least 12 consecutive weeks, or — if methotrexate is not tolerated — another disease-modifying drug at a stable dose for at least 28 days.
• For RA: People taking methotrexate who are also taking folic acid at the required dose alongside it.
• People who are willing and able to use effective contraception during the study and for at least 140 days after the last dose, and to follow sperm donation restrictions if male.
• Women of childbearing potential who have a negative pregnancy blood test within 7 days before the first dose.

Who may not be able to join:

• People with a very severe form of their autoimmune condition that could put their safety at risk or require treatments that might interfere with the study drug.
• People who have used certain strong topical (skin-applied) corticosteroid creams or changed the dose of other topical treatments within 28 days before the study start.
• People who have had a dose change in certain immunosuppressant or disease-modifying medications (such as methotrexate, mycophenolate, or azathioprine) within 28 days before the study start.
• People who have received certain medications — including cyclophosphamide, high-dose leflunomide, or abatacept — within 6 months before the study start.
• People who have received a monoclonal antibody (a type of biologic drug) or an experimental immune-modifying treatment within a certain period before the study start (confirm timeframe with trial site).
• People who have received rituximab or similar B-cell depleting drugs within 6 months before the study start, or whose immune cell counts have not returned to normal levels after such treatment.
• People who have ever received alemtuzumab, a bone marrow or stem cell transplant, total lymphoid irradiation, CAR-T therapy, or T-cell vaccination therapy.
• People with a known primary immune deficiency, HIV infection, a removed spleen, or any condition that significantly increases the risk of infection.
• People with a history of a severe allergic reaction or anaphylaxis to a monoclonal antibody or human immunoglobulin therapy.
• People with a current active infection or a history of serious infections as defined by the trial protocol (confirm with trial site).
• People who have had surgery within 28 days before the study start.
• People whose heart trace (ECG) results are outside the normal range after resting for 10 minutes.
• People with a significant, uncontrolled ongoing condition that could affect their ability to participate in the study (for example, severe lung disease).
• People who have had a cancer diagnosis within the past 5 years, with limited exceptions for certain treated skin cancers or cervical carcinoma in situ with no recurrence.
• People taking a high dose of antimalarial medication, or who have changed their antimalarial dose within 28 days before the study start.
• People taking systemic (whole-body) corticosteroids at more than 20 mg per day, or who have changed their corticosteroid dose within 28 days before the study start.
• People with a documented liver disease, including cirrhosis.
• People with a history of blood clotting events (such as blood clots, pulmonary embolism, or stroke), known clotting risk factors (including antiphospholipid syndrome), or who are currently taking blood-thinning medication.
• For SLE specifically: People with active, severe, or unstable neurological or psychiatric symptoms related to lupus at the time of screening (such as seizures, psychosis, or certain nerve-related conditions).
• For SLE specifically: People who have a confirmed lupus kidney disease diagnosis or significant unexplained protein in their urine at screening.

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