A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this trial is to measure safety and tolerability of subcutaneous (SC) VIS171 in combination with standard of care in participants with autoimmune disease(s). The total duration of the clinical trial for each participant will be up to approximately 9 to 12 months.
Eligibility Criteria
Inclusion Criteria: 1. Estimated glomerular filtration rate (eGFR) \>30 milliliters/minute/1.73 square meters (mL/min/1.73 m\^2) at the screening visit. For SLE participants: 2. Participant has a confirmed diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology SLE classification criteria ≥ 24 weeks prior to signing the informed consent form (ICF). For AA participants: 3. Current scalp involvement between 25% and 95%, inclusive (Severity of Alopecia Tool \[SALT\] score between 25 and 95, inclusive), at screening. 4. Current episode of AA is of duration \> 24 weeks (without evidence of spontaneous terminal hair regrowth at the time of screening and first treatment, i.e., no more than 10% regrowth), but ≤ 5 years from onset of current episode of severe scalp hair loss. For FSGS participants: 5. Prior biopsy (no time limit) showing histologic minimal change disease (MCD), FSGS, or MCD/FSGS spectrum. 6. History of at least one prior episode of neph