drugset / Trial / NCT03661138
A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Timeline
- Start
- 2018-10-27
- Primary completion
- 2022-08-19
- Completion
- 2022-08-19
Publications
- Katoh N, Ikeda M, Ohya Y, Murota H, Hu X, Liu J, Niiyama H, Sasaki T, Raymundo EM, Saeki H. Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: Analysis of the 3-Year Phase 3 Rising Up Study. Dermatol Ther (Heidelb). 2024 Jan;14(1):213-232. doi: 10.1007/s13555-023-01071-2. Epub 2023 Dec 21.
- Hayashi N, Ikeda M, Liu J, Raymundo E, Liu Y, Sasaki T, Yamasaki K. Acne Among Japanese Patients with Atopic Dermatitis Receiving Upadacitinib in the Phase 3 Rising Up Study. Dermatol Ther (Heidelb). 2023 Aug;13(8):1817-1830. doi: 10.1007/s13555-023-00961-9. Epub 2023 Jun 25.
- Katoh N, Ohya Y, Murota H, Ikeda M, Hu X, Ikeda K, Liu J, Sasaki T, Raymundo EM, Teixeira HD, Saeki H. Safety and Efficacy of Upadacitinib for Atopic Dermatitis in Japan: 2-Year Interim Results from the Phase 3 Rising Up Study. Dermatol Ther (Heidelb). 2023 Jan;13(1):221-234. doi: 10.1007/s13555-022-00842-7. Epub 2022 Nov 19.
- Tanaka T, Sasaki T, Ikeda K, Liu J, Tenorio AR, Ohya Y. Growth analysis among adolescents with moderate-to-severe atopic dermatitis receiving upadacitinib in combination with topical corticosteroids in Japan: A case study series from a phase 3, randomized, controlled trial (Rising Up). World Allergy Organ J. 2022 Sep 13;15(9):100678. doi: 10.1016/j.waojou.2022.100678. eCollection 2022 Sep.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Upadacitinib | Small molecule | 15 mg | Oral |
| Subject | Upadacitinib | Small molecule | 30 mg | Oral |