NEW YORK, N.Y., Oct. 24, 2023 – Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, announces a partnership with AbbVie Inc. for the Phase 3 clinical program of upadacitinib (RINVOQ®) in individuals living with systemic lupus erythematosus (SLE). In this partnership, Lupus Therapeutics will assist with study participant recruitment, site activation and engagement efforts through the Lupus Clinical Investigators Network (LuCIN) of top academic centers throughout North America.
Lupus is a devastating heterogeneous autoimmune disease affecting millions worldwide with wide-ranging symptoms from debilitating fatigue to life-threatening organ damage, with only one new treatment approved for SLE in the United States within the last 10 years. Lupus Therapeutics and the Lupus Research Alliance are committed to accelerating the development of potential treatments for a community in urgent need of more options.
Based on the results of a Phase 2 study, AbbVie advanced the clinical program of upadacitinib in SLE to Phase 3 earlier this year. The Phase 3 program (SELECT-SLE) of upadacitinib in SLE consists of two studies evaluating the effectiveness and safety of upadacitinib once daily oral tablets compared to placebo on top of standard of care background therapy, followed by a long-term extension. SELECT-SLE is currently underway and recruiting individuals living with SLE. Additional information about SELECT-SLE can be found at clinicaltrials.gov NCT05843643.
Discovered and developed by AbbVie, upadacitinib has been approved in the United States for use in seven immune-mediated diseases. Upadacitinib blocks certain signals within the body’s cells that are thought to cause inflammation. The use of upadacitinib in systemic lupus erythematosus is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
“The collaboration between Lupus Therapeutics and AbbVie will tap into the expertise of clinical researchers in the Lupus Clinical Investigators Network to help facilitate and improve the clinical trial process in the evaluation of upadacitinib in SLE,” commented Lupus Therapeutics Executive Vice President Stacie Bell, Ph.D. “Our aim is to accelerate the development of much-needed potential treatment options for SLE, allowing people with lupus to live better lives.”
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women, often striking during the childbearing years of 15-45. Blacks/African Americans, Hispanics, Asians, and Native Americans are at two to three times greater risk than Caucasians for developing lupus. In lupus, the immune system, meant to defend against infections, produces antibodies that mistakenly recognize the body’s own cells as foreign, prompting other immune cells to attack and potentially damage organs such as the kidneys, brain, heart, lungs, blood, skin, and joints.
About Lupus Therapeutics
Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, aims to accelerate the development of curative treatments for all patients living with lupus. Lupus Therapeutics collaborates with academic institutions, biotechnology, and pharmaceutical partners through the unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in the treatment of lupus patients. The organization elevates the patient voice, engages community stakeholders, and strives for representation of the diverse lupus community in the clinical research process with the most innovative and renowned experts throughout North America. Visit lupustherapeutics.org for more information.
About the Lupus Research Alliance
The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately, cure for lupus. Because the Lupus Research Alliance’s Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.