Phase I study of GSK45277363 in SLE patients
Phase I, first in human study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of GSK4527363 in participants with SLE.
Why this Research Matters
This is a multicenter study to investigate a single subcutaneous dose of GSK4527363 in participants with Systemic Lupus Erythematosus. The study population includes SLE patients who are currently on stable background SLE therapy.
Who can Participate
Documented clinical diagnosis of SLE with positive autoantibody test result. Participants must be current for all vaccinations in accordance with local guidelines, within a year of, and at least 30 days before, first dose. Participants must be on stable background SLE therapy. BMI should be within the range of 18-32 kg/m2. Female participants cannot be pregnant or breastfeeding to participate. Any severe active CNS lupus requiring therapy is excluded. Chronic oral steroid use for conditions besides SLE.
Study ID
Protocol Number: 25-1357
Meet the Team
Christopher Striebich, MD, PhD
Principal Investigator