From a Hard-to-Find Patient Population to a Positive Primary Endpoint in About 18 Months

Oral Lichen Planus (OLP) is a chronic, immune-mediated inflammatory disease of the oral mucosa, and symptomatic ulcerative and erythematous OLP that meets interventional-trial eligibility is uncommon. So, for this global, randomized, double-blind, placebo-controlled Phase 2 trial of a mucoadhesive intra-oral corticosteroid patch, conducted at 27 sites in 6 countries, the sponsor partnered with the dermatology specialists: Symbio. As coordinating CRO, Symbio managed 14 sites across the United States, United Kingdom, Germany and Denmark.

Through a multi-specialty site strategy and disciplined cross-border project management, the study was enrolled and completed in approximately 18 months and delivered a positive primary-endpoint readout.