SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE
About
This is a phase 3, double-blind, randomized, placebo-controlled study to evaluate the effectiveness and safety of upadacitinib, an oral study drug, in patients with SLE. After a 42-day screening period, participants will undergo a 52-week placebo-controlled treatment period, followed by an optional 52-week re-randomized double-blind extension treatment period. Subjects that had been receiving the upadacitinib and demonstrate low disease activity, will receive modified doses in a blinded fashion, and those that have not experienced a decrease in disease activity, will continue the initial blinded upadacitinib dose. Subjects that had been on placebo, will be transitioned to blinded upadacitinib.
Eligibility Criteria
Inclusion Criteria
- 18-63 years old, inclusive, at screening
- Must have been diagnosed with SLE at least 24 weeks prior to screening
- Meet the European Alliance of Associations for Rheumatology/American College of Rheumatology 2019 classification criteria for SLE
- Test positive for at least 1 of the following lupus-related autoantibodies at the time of screening: antinuclear antibody (ANA) ≥ 1:80, anti-dsDNA antibody, or anti-Smith antibody (anti-Sm)
- Have a total hSLEDAI score ≥ 6 points, and clinical hSLEDAI score ≥ 4 points (not based on laboratory criteria)
Exclusion Criteria
- Recent, recurring, or ongoing infections
- Clinically relevant or significant ECG abnormalities at Screening
- Exposure to prohibited immunomodulatory or biologic drugs within the washout period specified by the protocol
- Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments
- Lab findings or any medical condition that in the opinion of the investigator, would make the participant unsuitable for the study
Primary Investigator
Adegbenga A. Bankole, MD, has practiced rheumatology for more than 15 years. He specializes in systemic lupus erythematous (SLE) but has clinical expertise in myositis, rheumatoid arthritis, psoriasis, and gout. Dr. Bankole currently serves as Section Chief of Rheumatology; holds an academic appointment as an Associate Professor of Medicine at the Virginia Tech-Carilion School of Medicine; and is the Program Director for the Rheumatology Fellowship program. Dr. Bankole gets immense joy and satisfaction in helping patients improve the quality of their life by taking part in the management of their health care.
Contact Information
Gabriela Peregrino, M.A.
Clinical Research Coordinator
Mackenzie Eubank
Clinical Research Coordinator
