Phase 2 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 are willing to take part voluntarily and sign a consent form
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE) according to 2019 international classification guidelines, and whose condition has not responded well enough to standard treatment, cannot tolerate standard treatment, or whose disease has come back
• People whose SLE disease activity score (SLEDAI-2K) is 8 or higher, with a meaningful portion of that score coming from active physical symptoms
• People who have tested positive for certain immune system markers in their blood (ANA and/or anti-dsDNA antibodies)
• People who weigh at least 35 kg (approximately 77 pounds)
• People who have been on standard SLE treatment for at least 8 weeks before starting the trial, with the dose unchanged for at least the last 4 weeks
• People who are able to become pregnant, or whose partner is able to become pregnant, and who agree to use effective contraception throughout the study and for 6 months after the last dose

Who may not be able to join:

• People who have previously used a type of medication that targets a protein called CD38
• People who have had active disease affecting the brain or nervous system within the 2 months before the trial starts, or whose nervous system condition may need treatments that are not allowed in this trial
• People diagnosed with mixed connective tissue disease, or who have an overlapping diagnosis of SLE and systemic sclerosis
• People with certain abnormal laboratory (blood or urine) test results (confirm with trial site)
• People with certain active infections, either recent or ongoing (confirm with trial site for specific infection criteria)
• People who have taken part in another clinical trial within the 4 weeks before the trial starts (with some exceptions for those who only received a placebo or did not receive any trial treatment)
• People who have taken medications that target specific immune cells called T or B cells (for example, rituximab) within the 3 months before the trial starts
• People who have received certain other immune-suppressing medications (such as belimumab or telitacicept) within 4 weeks or 5 half-lives before the trial starts, whichever is the shorter period
• People who have taken a type of medication called a JAK inhibitor within 2 weeks before the trial starts
• People with serious heart or blood vessel disease
• People with a tuberculosis infection
• People living with HIV, active hepatitis B, or hepatitis C
• People with a known history of active syphilis
• People who have had a major organ transplant (such as heart, lung, kidney, or liver) or a stem cell or bone marrow transplant
• People whose doctor or the trial investigator believes should not participate for any other medical reason

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