Lupus Research Alliance Announces Series of Clinical Trials via LuCIN Partnerships
The Lupus Research Alliance has launched the first clinical trials conducted as part of its Lupus Clinical Investigators Network (LuCIN).
The alliance established LuCIN to speed the development of new lupus therapies, recognizing the limited options patients currently have. It comprises a series of strategic partnerships with the pharmaceutical and biotech industry.
According to a press release, the first portfolio of clinical studies include the following:
- A Phase 2 clinical trial (NCT02975336) to evaluate evobrutinib (M2951), a novel inhibitor of Bruton’s Tyrosine Kinase (BTK) in lupus. In partnership with Merck/EMD Serono and the alliance, researchers will study the potential of BTK inhibitors in lupus. BTK inhibitors, often used to treat blood cancer disorders, have a mechanism of action that suggests a potential benefit for the treatment of certain autoimmune diseases like lupus. The study will take place in up to 20 centers that are part of LuCIN’s North America network.
- A non-interventional clinical study, “Validation in Lupus of an Electronic Patient Reported Outcomes Tool (VALUE)” (NCT03142711). In partnership with Pfizer, the Lupus Research Alliance, AMPEL BioSolutions and Tata Consultancy Services, researchers will evaluate if a custom smartphone app enables lupus patients to report on their health-related quality of life and other symptoms in real time, rather than completing surveys when visiting their physicians. The app was designed with inputs from real-life lupus patients and developed using the Apple ResearchKit platform.
- A Phase 4 trial, called RIFLE (NCT03098823), to assess if Rayos (prednisone) is better than immediate-release prednisone at improving fatigue in lupus patients. In partnership with Horizon Pharma, the alliance, AMPEL BioSolutions, Carematix, Verizon and Samsung, researchers will test the effect of Rayos (prednisone) on severe fatigue and morning stiffness experienced by lupus patients. Rayos is the first low-dose, delayed-release form of the steroid prednisone, an anti-inflammatory drug. The study will also evaluate if a customized mobile app can measure fatigue, health-related quality of life, disease activity and morning stiffness.
- A collaborative study titled DIVINE (NCT03180021) to evaluate several kidney imaging modalities in the assessment of lupus nephritis. In partnership with the Lupus Research Alliance, AMPEL BioSolutions and ImageAnalysis, researchers will evaluate if replacing standard invasive surgical biopsy with magnetic resonance imaging (MRI) could potentially lead to better lupus assessments and treatment decisions, based on disease activity.
- In partnership with Celgene, a study will assess CC-220 as a treatment for lupus patients. CC-220 has been tested in a Phase 2 clinical trial (NCT02185040) where the candidate was considered safe by the U.S. Food and Drug Administration. Based on these results, Celgene will now enter a second Phase 2 study with CC-220 to evaluate whether the drug improves patient outcomes.
LuCIN connects 59 prestigious academic research centers in several North American cities and provides a framework to quickly and cheaply evaluate potential new therapies, as well as diagnosis and response to treatment monitoring methods. All active clinical studies are now recruiting participants.
More information about LuCIN and its clinical trials is available here.