A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

Overview

The purpose of this study is to compare the effectiveness and safety of upadacitinib (ABT-494) to placebo (pill without any active substance that looks like upadacitinib) in combination with topical corticosteroids for the treatment of adolescent (12-17 years of age) and adult (18-75 years of age) subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Description

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atopic Dermatitis
  • Age: Between 12 Years - 75 Years
  • Gender: Male or Female

Inclusion Criteria

Judged to be in general good health (other than AD) as determined by the Principal Investigator, based upon the results of medical history, laboratory profile, physical examination, chest x-ray, and a 12-lead electrocardiogram (ECG) performed during Screening.
Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
Has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit. Note: Subject may use prescription moisturizers or moisturizers containing ceramide, urea, filaggrin degradation products or hyaluronic acid if such moisturizers were initiated before the Screening Visit.
Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at the Baseline Visit prior to study drug dosing. Note: subjects with borderline pregnancy test at Screening must have a serum pregnancy test ≥ 3 days later to determine eligibility.
If female, subject must be postmenopausal OR permanently surgically sterile OR for females of childbearing potential practicing at least one protocol specified method of birth control, that is effective from the Baseline Visit through at least 30 days after the last dose of study drug.
Female subject must not be pregnant, breastfeeding or considering becoming pregnant during the study or for approximately 30 days after the last dose of the study drug.

Updated on 30 Nov 2022 . Study ID: TX10342

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