Pediatric Clinical Trial Program: Phase 3 and Long-term Extension Study of Ritlecitinib in Children Aged 6 to 12 Years With Severe Alopecia Areata

The document outlines an ongoing phase 3 and long-term extension study evaluating the efficacy and safety of ritlecitinib in children aged 6 to <12 years with severe alopecia areata (AA). Ritlecitinib, a dual inhibitor of JAK3 and TEC family kinases, is already approved for older age groups but lacks approval for younger children. The phase 3 study involves approximately 225 children with ≥50% scalp hair loss, randomized to receive either ritlecitinib or placebo for 24 weeks, with primary efficacy measured by a SALT score improvement. The long-term extension study will include around 140 participants to assess long-term safety and efficacy over 36 months. The primary endpoints focus on adverse events, while secondary endpoints evaluate efficacy and psychological impacts.