Pediatric Clinical Trial Program: Phase 3 and Long-term Extension Study of Ritlecitinib in Children Aged 6 to 12 Years With Severe Alopecia Areata
March 2026
in “
SKIN The Journal of Cutaneous Medicine
”
New to Alopecia Areata? There is a guide in the encyclopedia. Read the guide → Studysummary This study found that ritlecitinib was well tolerated in children aged 6 to under 12 years with severe alopecia areata, with ongoing trials examining its efficacy and safety over a 24-week period and in long-term use up to 36 months.
Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer
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.
