RecruitingNCT06937788

Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data


Sponsor

Technische Universität Dresden

Enrollment

240 participants

Start Date

Aug 2, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria1

  • contraindications according to upadacitinib or dupilumab labeling

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Interventions

DRUGUpadacitinib

30 mg tablet daily

BIOLOGICALDupilumab

300 mg injection every other week


Locations(1)

Center for Evidence Based Health Care

Dresden, Saxony, Germany

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NCT06937788


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