Rationale and Design of a Novel, Phase 3, External and Synthetic Placebo-Controlled Clinical Trial of Ritlecitinib 50 mg and 100 mg for Alopecia Areata

    October 2025 in “ Dermatology and Therapy ”
    Brett King, Amy McMichael, Rodney Sinclair … Satrajit Roychoudhury
    Studysummary This study evaluates the efficacy and safety of a higher dose (100-mg) of ritlecitinib for treating severe alopecia areata, comparing it to external and synthetic placebo control groups.
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    Research cited in this study 19

    1. Statement From The Frontal Fibrosing Alopecia International Expert Alliance: SOFFIA 2024 Journal of the European Academy of Dermatology and Venereology · 2025
    2. Patterns of Clinical Response in Patients With Alopecia Areata Treated With Ritlecitinib in the Allegro Clinical Development Programme Journal of the European Academy of Dermatology and Venereology · 2025
    3. Psychosocial Impact of Alopecia Areata in Pediatric and Adolescent Populations: A Systematic Review Journal of Paediatrics and Child Health · 2024
    4. Efficacy and Safety of Deuruxolitinib, an Oral Selective Janus Kinase Inhibitor, in Adults with Alopecia Areata: Results from the Phase 3 Randomized, Controlled Trial (THRIVE-AA1) Journal of the American Academy of Dermatology · 2024
    5. A Phase 2a Study Investigating the Effects of Ritlecitinib on Brainstem Auditory Evoked Potentials and Intraepidermal Nerve Fiber Histology in Adults with Alopecia Areata Pharmacology Research & Perspectives · 2024
    6. Moving Beyond Boundaries: Utilization of Longitudinal Exposure–Response Model for Bounded Outcome Score to Inform Decision Making in the Accelerated Drug Development Paradigm Clinical Pharmacokinetics · 2024
    7. Inhibition of T-Cell Activity in Alopecia Areata: Recent Developments and New Directions Frontiers in immunology · 2023
    8. Efficacy and Safety of Ritlecitinib in Adults and Adolescents With Alopecia Areata: A Randomised, Double-Blind, Multicentre, Phase 2b–3 Trial The Lancet · 2023
    9. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata Over 52 Weeks in Phase III Trials American Journal of Clinical Dermatology · 2023
    10. Two Phase 3 Trials of Baricitinib for Alopecia Areata The New England Journal of Medicine · 2022
    11. Ritlecitinib And Brepocitinib Demonstrate Significant Improvement In Scalp Alopecia Areata Biomarkers ˆThe ‰journal of allergy and clinical immunology/Journal of allergy and clinical immunology/˜The œjournal of allergy and clinical immunology · 2021
    12. A Phase 2a Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of the Oral Janus Kinase Inhibitors Ritlecitinib and Brepocitinib in Alopecia Areata: 24-Week Results Journal of the American Academy of Dermatology · 2021
    13. Hair Follicle Immune Privilege and Its Collapse in Alopecia Areata Experimental dermatology · 2020
    14. Targeting the Janus Kinase Family in Autoimmune Skin Diseases Frontiers in Immunology · 2019
    15. Treatment of Alopecia Areata: An Australian Expert Consensus Statement Australasian journal of dermatology · 2018
    16. Role of Janus Kinase Inhibitors in the Treatment of Alopecia Areata Drug design, development and therapy · 2018
    17. Familial Aggregation of Alopecia Areata Journal of the American Academy of Dermatology · 2016
    18. The Autoimmune Basis of Alopecia Areata: A Comprehensive Review Autoimmunity reviews · 2014
    19. Lymphocytes, Neuropeptides, And Genes Involved In Alopecia Areata Journal of Clinical Investigation · 2007