Replication of the Heads Up Atopic Dermatitis Trial With Registry Data
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Upadacitinib, Dupilumab.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data
Overview
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.
Interventions
- Drug Upadacitinib
30 mg tablet daily - Biological Dupilumab
300 mg injection every other week
Primary outcome measures
- POEM [Time frame: baseline to month 6]
Secondary outcome measures (6)
- DLQI [Time frame: from baseline to month 6]
- RECAP [Time frame: from baseline to month 6]
- EASI [Time frame: from baseline to month 6]
- NRS Itch (past 3 days) [Time frame: from baseline to month 6]
- NRS sleeping problems (past 3 days) [Time frame: from baseline to month 6]
- EASI 75 [Time frame: from baseline to month 6]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Germany · 1 center
- Center for Evidence Based Health Care — Dresden
Identifiers
NCT: NCT06937788 · TTE_101_TREATGer