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
Study on the Safety and Effectiveness of an Investigational Medication for Atopic Dermatitis
Brief description of study.
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Atopic Dermatitis
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Age: 12 years - 75 years
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Gender: All
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.
This study investigates the safety and effectiveness of an investigational medication compared to a placebo in treating moderate to severe atopic dermatitis. Atopic dermatitis, also known as eczema, is a condition that makes the skin red and itchy. The study is for adolescents aged 12-17 and adults aged 18-75 who are candidates for systemic therapy, which means they need treatment that affects the entire body.
Participants will receive either the investigational medication or a placebo, both in combination with topical corticosteroids. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will involve various procedures, including medical history reviews, laboratory tests, and physical exams.
- Who can participate: Participants must be in general good health apart from having chronic atopic dermatitis for at least 3 years. They should have used a moisturizer twice daily for at least 7 days before the Baseline Visit. Females must not be pregnant and must use effective birth control during the study.
- Study details: Participants will either receive the investigational medication or a placebo, which is a pill without any active substance, along with topical corticosteroids. They will undergo medical history reviews, laboratory tests, and physical exams to monitor their health.