A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

Summary

The objective of this study was to evaluate the safety and efficacy of multiple doses of upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis (AD).

Timeline

Start

2016-10-25

Primary completion

2017-08-10

Completion

2019-01-31

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Upadacitinib 30 mg; p < 0.001; Least Squares (LS) Mean Difference -51.4 (95% CI -66.5 to -36.3); ANCOVA NCT02925117 ↗

registry analysis (superiority test); Placebo vs Upadacitinib 15 mg; p <0.001; LS Mean Difference -38.7 (95% CI -53.7 to -23.6); ANCOVA NCT02925117 ↗

registry analysis (superiority test); Placebo vs Upadacitinib 7.5 mg; p = 0.032; LS Mean Difference -16.4 (95% CI -31.4 to -1.4); ANCOVA NCT02925117 ↗

Publications

• Results Guttman-Yassky E, Thaci D, Pangan AL, Hong HC, Papp KA, Reich K, Beck LA, Mohamed MF, Othman AA, Anderson JK, Gu Y, Teixeira HD, Silverberg JI. Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020 Mar;145(3):877-884. doi: 10.1016/j.jaci.2019.11.025. Epub 2019 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Upadacitinib	Small molecule	7.5 mg	Oral
Subject	Upadacitinib	Small molecule	15 mg	Oral
Subject	Upadacitinib	Small molecule	30 mg	Oral

Indications