Replication of the Heads Up Atopic Dermatitis Trial With Registry Data
Re-HU-TREAT
Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data
1 other identifier
observational
240
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2021
CompletedFirst Submitted
Initial submission to the registry
April 14, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 21, 2025
August 1, 2025
4.4 years
April 14, 2025
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
POEM
Mean POEM change
baseline to month 6
Secondary Outcomes (6)
DLQI
from baseline to month 6
RECAP
from baseline to month 6
EASI
from baseline to month 6
NRS Itch (past 3 days)
from baseline to month 6
NRS sleeping problems (past 3 days)
from baseline to month 6
- +1 more secondary outcomes
Study Arms (2)
Upadacitinib (treatment group)
Dupilumab (active comparator)
Interventions
Eligibility Criteria
Adult subjects with moderate to severe atopic dermatitis enrolled in the TREATgermany disease registry who are candidates for systemic therapy.
You may qualify if:
- 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
You may not qualify if:
- contraindications according to upadacitinib or dupilumab labeling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Evidence Based Health Care
Dresden, Saxony, 01307, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jochen M Schmitt
Center for Evidence-based Healthcare, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2025
First Posted
April 22, 2025
Study Start
August 2, 2021
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
August 21, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
Pseudonymized data can be shared after receipt of data request outlining research question and data/variables needed and approval by TREATgermany prinicipal investigators.