Replication of the Heads Up Atopic Dermatitis Trial With Registry Data
Recruiting · NCT06937788 · Observational (researchers observe without assigning treatment) · Lead sponsor: Technische Universität Dresden
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Center for Evidence Based Health Care - Dresden, Saxony, Germany