Replication of the Heads Up Atopic Dermatitis Trial With Registry Data
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnische Universität Dresden
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
contraindications according to upadacitinib or dupilumab labeling
Trial population
Adult subjects with moderate to severe atopic dermatitis enrolled in the TREATgermany disease registry who are candidates for systemic therapy.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Upadacitinib
Drug30 mg tablet daily
Dupilumab
Biological/Vaccine300 mg injection every other week
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Upadacitinib (treatment group)1 intervention
Group B: Dupilumab (active comparator)1 intervention
Trial outcomes
Primary outcomes
1
POEM
Mean POEM change
Time frame
baseline to month 6Secondary outcomes
1
DLQI
Mean DLQI change
Time frame
from baseline to month 62
RECAP
Mean RECAP change
Time frame
from baseline to month 63
EASI
Mean EASI change
Time frame
from baseline to month 64
NRS Itch (past 3 days)
Mean NRS Itch (past 3 days) change
Time frame
from baseline to month 6Sponsors and contacts
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Source ClinicalTrials.gov