Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

Sponsor
Technische Universität Dresden
Study ID
NCT06937788
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Aug 2, 2021
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: Upadacitinib (treatment group)
  • Arm: Dupilumab (active comparator)

Primary Outcome Measure

POEM [ Time Frame: baseline to month 6 ]

Central Contacts

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