drugset / Trial / NCT03745651
TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess the efficacy of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).
Timeline
- Start
- 2018-12-20
- Primary completion
- 2019-11-18
- Completion
- 2020-11-09
Outcome
Met primary endpoint
registry analysis (superiority test); VC Period: Vehicle Cream BID vs VC Period: Ruxolitinib 0.75% Cream BID; p < 0.0001; NCT03745651 ↗
registry analysis (superiority test); VC Period: Vehicle Cream BID vs VC Period: Ruxolitinib 1.5% Cream BID; p < 0.0001; NCT03745651 ↗
release “TRuE-AD2: 51.3%] achieved IGA-TS compared to vehicle [non-medicated cream; TRuE-AD1: 15.1%; TRuE-AD2: 7.6%]; P < 0.0001.” incyte.com ↗
release “The primary and secondary endpoints were met in both TRuE-AD1 and TRuE-AD2.” incyte.com ↗
Publications
- Blauvelt A, Kircik L, Simpson EL, Lio P, Eichenfield LF, Prajapati VH, Grewal P, Lynde C, Hong HC, Sturm D, Kallender H, Ren H, Paranagama D, Wong GKW, Geng B. Ruxolitinib Cream As-Needed Monotherapy Demonstrates Sustained Disease and Symptom Control in Patients with Mild to Moderate Atopic Dermatitis: Pooled Analysis from Two Phase 3 Studies. Dermatol Ther (Heidelb). 2026 Mar;16(3):1635-1646. doi: 10.1007/s13555-025-01639-0. Epub 2026 Feb 12.
- Simpson EL, Augustin M, Thaci D, Misery L, Armstrong AW, Blauvelt A, Papp KA, Szepietowski JC, Boguniewicz M, Kwatra SG, Kallender H, Sturm D, Ren H, Kircik L. Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies. Am J Clin Dermatol. 2025 Jan;26(1):121-137. doi: 10.1007/s40257-024-00901-z. Epub 2024 Nov 15.
- Blauvelt A, Kallender H, Sturm D, Li Q, Ren H, Eichenfield LF. Efficacy and Safety of Ruxolitinib Cream in Atopic Dermatitis Based on Previous Medication History. Dermatol Ther (Heidelb). 2024 Nov;14(11):3161-3174. doi: 10.1007/s13555-024-01272-3. Epub 2024 Oct 7.
- Simpson EL, Kircik L, Blauvelt A, Kallender H, Sturm D, Wang M, Eichenfield LF. Ruxolitinib Cream in Adolescents/Adults with Atopic Dermatitis Meeting Severity Thresholds for Systemic Therapy: Exploratory Analysis of Pooled Results from Two Phase 3 Studies. Dermatol Ther (Heidelb). 2024 Aug;14(8):2139-2151. doi: 10.1007/s13555-024-01219-8. Epub 2024 Jul 12.
- Eichenfield LF, Simpson EL, Papp K, Szepietowski JC, Blauvelt A, Kircik L, Silverberg JI, Siegfried EC, Kuligowski ME, Venturanza ME, Kallender H, Ren H, Paller AS. Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Randomized Phase 3 Studies. Am J Clin Dermatol. 2024 Jul;25(4):669-683. doi: 10.1007/s40257-024-00855-2. Epub 2024 May 2.
- Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Forman SB, Kuligowski ME, Kallender H, Sun K, Ren H, Simpson EL. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. J Am Acad Dermatol. 2023 May;88(5):1008-1016. doi: 10.1016/j.jaad.2022.09.060. Epub 2022 Nov 26.
- Bloudek L, Eichenfield LF, Silverberg JI, Joish VN, Lofland JH, Sun K, Augustin M, Migliaccio-Walle K, Sullivan SD. Impact of Ruxolitinib Cream on Work Productivity and Activity Impairment and Associated Indirect Costs in Patients with Atopic Dermatitis: Pooled Results From Two Phase III Studies. Am J Clin Dermatol. 2023 Jan;24(1):109-117. doi: 10.1007/s40257-022-00734-8. Epub 2022 Oct 20.
- Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.
- Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, Simpson EL. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085. Epub 2021 May 4.
- Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 0.75 % | Topical |
| Subject | Ruxolitinib | Small molecule | 1.5 % | Topical |