This is an open-label, ascending dose, uncontrolled study in participants with SLE systemic lupus erythematosus (SLE). PIT565 will be administered subcutaneously (s.c.) following premedication.
Up to 8 cohorts are planned. Every cohort will start with 3 sentinel participants and, depending on safety as well as observed biological activity, may have additional optional participants. The decision to escalate the dose from one cohort to the next will be based both on safety and PD data. After the identification of a dose level that has been declared safe and has induced predefined B cell depletion in 100% of the participants (candidate dose level), the cohort from this candidate dose level can be expanded with up to 12 additional participants (up to a total of 15 participants per cohort).
