Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Observational
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Center for Evidence Based Health Care
RECRUITING
Dresden
Contact Information
Primary
Thomas Birkner
Thomas.Birkner@ukdd.de
+4935145889937
Time Frame
Start Date: 2021-08-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 240
Treatments
Upadacitinib (treatment group)
Dupilumab (active comparator)
Related Therapeutic Areas
Sponsors
Leads: Technische Universität Dresden