The Lupus Research Alliance today announced the first clinical trials to be conducted through its Lupus Clinical Investigators Network (LuCIN) aimed at discovering new treatments for the millions of people around the globe living with lupus.
Recognizing the limited treatments for lupus, LuCIN was organized, managed and is funded by the Lupus Research Alliance to address the slow pace of development of new lupus therapies. With 59 of the most prestigious academic research centers in major cities throughout North America, LuCIN provides a framework to quickly and cost-effectively test potential new therapies, as well as methods to diagnose and monitor response to treatment.
Managing lupus is challenging because no two cases are alike and symptoms vary widely. While better treatments and medical care have improved life expectancy, lupus is still not adequately controlled in many people, and the disease often progresses. Also, many current therapies carry risks of debilitating side effects.
Inaugural LuCIN Clinical Studies
The Lupus Research Alliance has forged several strategic partnerships with the pharmaceutical/biotech industry to launch its first portfolio of clinical studies within LuCIN.
The non-profit organization is collaborating with Celgene Corporation to further study CC-220, an oral drug being developed to treat systemic lupus erythematosus. Based on results of earlier studies, as well as the unmet medical need for safe and effective oral therapies, Celgene will further evaluate this drug candidate within LuCIN in a global multicenter, placebo-controlled Phase II clinical study.
In partnership with Pfizer Inc., a non-interventional clinical study entitled VAlidation in LUpus of an Electronic Patient Reported Outcomes Tool (VALUE) has been initiated within LuCIN to test a custom smartphone app enabling lupus patients to report on their health-related quality of life and fatigue and other symptoms in real time rather than completing surveys during visits to physicians’ offices. The app was designed with input from people with lupus. Pfizer Inc., the Lupus Research Alliance, AMPEL BioSolutions and Tata Consultancy Services Ltd. jointly developed the new mobile app, using the Apple ResearchKit platform and building on existing research tools that have been validated in lupus.
In conjunction with Horizon Pharma, the clinical study entitled Rayos Inhibits Fatigue in Lupus Erythematosus (RIFLE) will test the effect of RAYOS® on severe fatigue and morning stiffness often experienced by people with lupus. RAYOS is the first low-dose, delayed-release form of the steroid prednisone, a widely prescribed anti-inflammatory drug. RIFLE also tests a customized mobile app to measure fatigue, health-related quality of life, disease activity and morning stiffness throughout the trial. RIFLE is a collaboration between the Lupus Research Alliance, AMPEL BioSolutions, Carematix, Verizon and Samsung.
Another study, entitled Dynamic Imaging to Assess Variation in Lupus Nephritis (DIVINE), has the potential to replace standard invasive surgical biopsy with sophisticated MRI technology to assess lupus nephritis and better tailor treatment decisions based on disease activity. This study is a collaboration between the Lupus Research Alliance, AMPEL BioSolutions and ImageAnalysis.
The Lupus Research Alliance, in partnership with Merck/EMD Serono is collaborating on a phase II clinical study to evaluate M2951, a novel inhibitor of Bruton’s Tyrosine Kinase (BTK) in Lupus, within the Lupus Research Alliance Lupus Clinical Investigators Network (LuCIN). Although BTK inhibitors are used as a therapy to treat individuals with blood cancer disorders, the mechanism of action of BTK suggests a use for the potential treatment of autoimmune diseases, including Lupus. Up to 20 LuCIN centers geographically disbursed throughout North America will be participating in the clinical study.
“The Lupus Research Alliance is excited and proud to take the lead in conducting clinical trials that will accelerate the process of developing new treatments for lupus, and improve tools to diagnose and monitor the disease,” said Albert Roy, Executive Director of LuCIN. “These first trials are landmarks for the lupus community and will offer patients a meaningful way to get involved and make a real difference in improving care.”
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90% of lupus sufferers are women, mostly young women between the ages of 15 to 44. Women of color are especially at risk. In lupus, the immune system, which is designed to protect against infection, creates antibodies that attack the body’s own tissues and organs — the kidneys, brain, heart, lungs, blood, skin, and joints.
About the Lupus Research Alliance
The Lupus Research Alliance leads the quest to free the world from lupus through the power of science. The 501 (c)(3) is the only international private funder devoted to lupus research. The organization propels lupus research in new directions to pursue better treatments while driving to a cure. Because the Lupus Research Alliance Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs. And with pivotal discoveries, the Lupus Research Alliance is breaking through.