Overview
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
Description
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 have 3 sentinel participants and, depending on safety as well as observed biological activity, may have up to 3 additional optional participants (up to 6 participants per cohort). 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 optionally be enriched with 6 additional participants (up to a total of 12 participants).
Eligibility
Inclusion Criteria:
- Diagnosis of SLE according to the 2019 ACR/EULAR criteria
- Documentation of SLE autoantibodies
- Active SLE disease, as demonstrated by a SLEDAI-2K ≥ 4 at screening
- Failure to respond to standard-of-care medicines for the treatment of SLE as detailed in the protocol
- Immunization against pneumococcus, influenza, and COVID-19
Exclusion Criteria:
- Severe SLE-related organ damage dysfunction or life-threatening disease at screening.
- Any acute, severe lupus-related flare during screening that needs immediate treatment such as acute CNS lupus (e.g., psychosis, epilepsy) or catastrophic antiphospholipid syndrome.
- Presence of severe lupus kidney disease as defined by worsening proteinuria or estimated glomerular filtration rate (eGFR) which in the opinion of the Investigator requires immune-suppressive induction or maintenance treatment at screening.
- History or current diagnosis of ECG or cardiac abnormalities indicating a significant risk of safety for participants.
- Use of prohibited medication defined in the protocol.
- Clinically significant active, opportunistic, chronic or recurrent infection (including, HIV, HBV, HCV) confirmed one month prior to or during screening.
- Serious medical illness likely to interfere with participation in this clinical study.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they are using highly effective methods of contraception
Other protocol defined inclusion/exclusion criteria mat apply.