JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Summary
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderate to severe AD.
Timeline
- Start
- 2019-02-18
- Primary completion
- 2020-04-08
- Completion
- 2020-04-08
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs PF-04965842 100mg QD; p = 0.0147; Estimate of difference 16.7 (95% CI 3.5 to 29.9); Cochran-Mantel-Haenszel NCT03796676 ↗
registry analysis (superiority test); Placebo vs PF-04965842 200mg QD; p = 0.0030; Estimate of difference 20.6 (95% CI 7.3 to 33.9); Cochran-Mantel-Haenszel NCT03796676 ↗
registry analysis (superiority test); Placebo vs PF-04965842 100mg QD; p = 0.0002; Estimate of difference 26.5 (95% CI 13.1 to 39.8); Cochran-Mantel-Haenszel NCT03796676 ↗
registry analysis (superiority test); Placebo vs PF-04965842 200mg QD; p <0.0001; Estimate of difference 29.4 (95% CI 16.3 to 42.5); Cochran-Mantel-Haenszel NCT03796676 ↗
Publications
- 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.
- Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.
- Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19.
- Cork MJ, McMichael A, Teng J, Valdez H, Rojo R, Chan G, Zhang F, Myers DE, DiBonaventura M. Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):422-433. doi: 10.1111/jdv.17792. Epub 2021 Dec 4.
- Eichenfield LF, Flohr C, Sidbury R, Siegfried E, Szalai Z, Galus R, Yao Z, Takahashi H, Barbarot S, Feeney C, Zhang F, DiBonaventura M, Rojo R, Valdez H, Chan G. Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial. JAMA Dermatol. 2021 Oct 1;157(10):1165-1173. doi: 10.1001/jamadermatol.2021.2830.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abrocitinib | Small molecule | 100 mg | Oral |
| Subject | Abrocitinib | Small molecule | 200 mg | Oral |