Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-02

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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Atopic dermatitis (AD) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and negative consequences on quality of life. The goal of this study is the replication of the primary outcome (Eczema Area and Severity Index (EASI) 75 at week 16) of the Heads Up trial and the evaluation of the patient reported outcomes (Patient-oriented Eczema Measure (POEM), Dermatologic Quality of Life Index (DLQI) and Recap of Atopic Eczema (RECAP)) that were not assessed in the Heads Up trial but are part of the recommendations by the Harmonising Outcome Measures for Eczema (HOME) initiative (Williams, HC, Schmitt, J, Thomas, KS et al (2022) doi:10.1016\\j.jaci.2022.03.017) regarding core outcome sets in atopic dermatitis clinical trials. The core outcome set as defined by HOME encompasses the following domains (core outcome instruments): clinical signs (EASI), patient-reported symptoms (POEM and Peak Itch), long term control (RECAP) and quality of life (DLQI). The data basis is the TREATgermany registry (https://treatgermany.org/). TREATgermany is a national clinical registry for patients with moderate to severe AD. The physician and patient-reported outcomes are collected in about 60 clinics and private practices during routine care. Data of more than 2,400 patients is currently documented.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Upadacitinib (treatment group)

Upadacitinib

Intervention Type DRUG

30 mg tablet daily

Dupilumab (active comparator)

Dupilumab

Intervention Type BIOLOGICAL

300 mg injection every other week

Interventions

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Upadacitinib

30 mg tablet daily

Intervention Type DRUG

Dupilumab

300 mg injection every other week

Intervention Type BIOLOGICAL

Eligibility Criteria

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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