Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Summary

This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.

Timeline

Start

2020-06-11

Primary completion

2021-07-13

Completion

2021-07-13

Publications

• Weidinger S, Reich K, Issa N, Hong HC, Bunick CG, Biswas P, Chan G, Guler E, Watkins M, Alderfer J. Abrocitinib Achieves Early and Complete/Near-Complete Skin Clearance Plus Itch-Free State in Atopic Dermatitis: Phase 3 Pooled Post Hoc Analysis. Dermatol Ther (Heidelb). 2026 Jun 27. doi: 10.1007/s13555-026-01833-8. Online ahead of print.
• Silverberg JI, Simpson EL, Farooqui SA, Chan G, Biswas P, Guler E. Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis. Dermatol Ther (Heidelb). 2026 May 20. doi: 10.1007/s13555-026-01778-y. Online ahead of print.
• Yosipovitch G, Gooderham MJ, Elmariah SB, Bonfanti G, Edwards RA, Gregoriou S, Biswas P, Myers DE, Alderfer J, Guler E, Koulias C. Itch Relief and Quality-of-Life Improvement with Abrocitinib and Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE COMPARE and JADE DARE. Am J Clin Dermatol. 2026 May 5. doi: 10.1007/s40257-026-01030-5. Online ahead of print.
• Simpson EL, Silverberg JI, Geng B, Carrascosa JM, Bieber T, Brunner PM, Staumont-Salle D, Ji C, Biswas P, Feeney C, Hernandez-Martin I, Rebollo Laserna FJ, Koppensteiner H. Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis? Dermatol Ther (Heidelb). 2025 Nov;15(11):3391-3407. doi: 10.1007/s13555-025-01516-w. Epub 2025 Sep 23.
• Silverberg JI, Simpson EL, Pink AE, Weidinger S, Chan G, Biswas P, Clibborn C, Guler E. Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE. Dermatol Ther (Heidelb). 2025 Feb;15(2):367-380. doi: 10.1007/s13555-024-01320-y. Epub 2025 Feb 4.
• Reich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice ZP, Hong HC, Katoh N, Valenzuela F, DiBonaventura M, Bratt TA, Zhang F, Clibborn C, Rojo R, Valdez H, Kerkmann U. Comparing how well abrocitinib and dupilumab treat atopic dermatitis signs and symptoms: a plain language summary. Immunotherapy. 2023 Sep;15(13):975-980. doi: 10.2217/imt-2022-0306. Epub 2023 May 31.
• Reich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice ZP, Hong HC, Katoh N, Valenzuela F, DiBonaventura M, Bratt TA, Zhang F, Clibborn C, Rojo R, Valdez H, Kerkmann U. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet. 2022 Jul 23;400(10348):273-282. doi: 10.1016/S0140-6736(22)01199-0.

Drugs

Indications