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
Child to Adult
Subjects must meet all of the following criteria in order to be included in the study. Anything other than a positive response to the questions below will result in exclusion from study participation. Consent and Demographics 1. Subject must be at least ≥ 12 years old and ≤ 75 years old at Screening Visit. Adolescent subjects age ≥ 12 to < 18 years old may be enrolled if approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old at the Screening Visit will be enrolled. 2. Adult subjects ≥ 18 years of age at Screening Visit or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures and comply with the requirements of this study protocol. In Japan, if a subject is under 20 years of age, then the subject and their parent or legal guardian must voluntarily sign and date an informed consent. 3. For subjects ≥ 12 years old and < 18 years old at Screening Visit: Parent or legal guardian, as required, has voluntarily signed and dated an informed consent form, approved by an IEC, after the nature of the study has been explained and the subject's parent or legal guardian has had the opportunity to ask questions. Subjects will be included in all discussions in order to obtain verbal/and or written assent. Parent/legal guardian and subject must comply with the requirements of this study protocol. If a subject becomes of legal age during the course of the study, that subject will need to be consented using the approved informed consent form. 4. Body weight ≥ 40 kg at the Baseline Visit for subjects between ≥ 12 and < 18 years of age. 5. Subject is 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. AD Disease Activity 6. Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria;23 7. Subject meets all of the following disease activity criteria: • EASI score ≥ 16 at the Screening and Baseline Visits; • vIGA-AD score ≥ 3 at the Screening and Baseline Visits; • ≥ 10% BSA of AD involvement at the Screening and Baseline Visits; • Baseline weekly average of daily worst pruritus NRS ≥ 4. Note: The Baseline weekly average of daily worst pruritus NRS will be calculated from the 7 consecutive days immediately preceding the Baseline Visit. A minimum of 4 daily scores out of the 7 days is needed. 8. Subject 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. 9. Documented history (within 6 months prior to the Baseline Visit) of inadequate response to TCS or topical calcineurin inhibitor (TCI) OR documented systemic treatment for AD within 6 months prior to the Baseline Visit.
II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
University of Colorado Hospital
Cory Dunnick, MD
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