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Recruiting NCT06937788
Replication of the Heads Up Atopic Dermatitis Trial With Registry Data
Trial Parameters
Condition Atopic Dermatitis
Sponsor Technische Universität Dresden
Study Type OBSERVATIONAL
Phase N/A
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-08-02
Completion 2025-12-31
Interventions
UpadacitinibDupilumab
Brief Summary
The goal is the replication of the primary outcome (EASI 75 at week 16) of the Heads Up trial (Blauvelt, A, Teixeira, H, Simpson, E et al (2021) doi:10.1001/jamadermatol.2021.3023) and the evaluation of the patient reported outcomes (POEM, DLQI and RECAP) in a head-to-head comparison of upadacitinib versus dupilumab treatment in moderate-to-severe atopic dermatitis (AD).
Eligibility Criteria
Inclusion Criteria: * Chronic AD with onset of symptoms at least 3 years prior to baseline * Meets UK working party criteria * EASI score ≥ 16 * ≥ 10% body surface area (BSA) of AD involvement at baseline ("therapy start") visit Exclusion Criteria: * contraindications according to upadacitinib or dupilumab labeling
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