clinical trials

Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus

The Lupus Research Alliance applauds the decision by the U.S. Food and Drug Administration (FDA) to grant Breakthrough Therapy designation for litifilimab (BIIB059) in clinical development by Biogen Inc. for the treatment of cutaneous lupus erythematosus (CLE) – a chronic skin disease for which there are no specifically approved treatments. The FDA grants this designation to expedite the review of drugs that may demonstrate substantial improvement over available therapies.   A common manifestation of lupus – a chronic and complex autoimmune disease – CLE primarily causes inflammation of the skin. Symptoms vary, but can include butterfly rashes, ring-shaped sores, or red, Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus

Turning the Tide in Lupus Treatment: Clinical Trials as Standard of Care

People living with lupus can have early access to innovative therapies alongside personalized support from a broader care team. How? Through participation in clinical trials.  Historically, clinical trial participation for lupus was discussed only after standard treatments failed the patient. Now, Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance, is working to make Turning the Tide in Lupus Treatment: Clinical Trials as Standard of Care

Lupus Clinical Research: A New Wave of Innovation 

A wave of lupus clinical research advances has been building over the past decade.  Now, it is reaching a crest.  A 2025 pipeline report identifies over 140 lupus therapies from 120+ companies now in clinical trials.i This surge of innovation is translating into potential treatments that are targeted, safer, and showing potential effectiveness for people living with lupus—offering more choices and options for treating the disease.  “This is Lupus Clinical Research: A New Wave of Innovation