Clinical trial NCT06937788: Replication of the Heads Up Atopic Dermatitis Trial With Registry Data
Official title: Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis
Keywords: observational
target trial emulation
dupilumab
upadacitinib
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with moderate to severe atopic dermatitis enrolled in the TREATgermany disease registry who are candidates for systemic therapy.

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).

Detailed description: 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.

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

Primary outcomes:
measure: POEM
timeFrame: baseline to month 6
Secondary outcomes:
measure: DLQI
timeFrame: from baseline to month 6
measure: RECAP
timeFrame: from baseline to month 6
measure: EASI
timeFrame: from baseline to month 6
measure: NRS Itch (past 3 days)
timeFrame: from baseline to month 6
measure: NRS sleeping problems (past 3 days)
timeFrame: from baseline to month 6
measure: EASI 75
timeFrame: from baseline to month 6
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Center for Evidence Based Health Care
state: Saxony
Study officials:
affiliation: Center for Evidence-based Healthcare, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden
name: Jochen M Schmitt
role: PRINCIPAL_INVESTIGATOR
References: