Comparing upadacitinib and dupilumab using real-world registry data
Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data
This project will try to see if people with moderate-to-severe atopic dermatitis get the same skin-clearing results at 16 weeks with upadacitinib versus dupilumab using routine-care registry data.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Drugs / interventions | dupilumab, upadacitinib |
| Locations | 1 site (Dresden, Saxony) |
| Trial ID | NCT06937788 on ClinicalTrials.gov |
What this trial studies
This observational target-trial emulation uses the TREATgermany registry to compare outcomes for patients starting upadacitinib versus dupilumab in routine clinical care. The primary goal is to replicate the Heads Up trial primary outcome of EASI 75 at week 16 and to add patient-reported outcomes (POEM, DLQI, RECAP) that were not included in the original trial. Data are drawn from over 2,400 patients documented across roughly 60 clinics and practices, with eligibility defined by chronic moderate-to-severe AD (EASI ≥16, ≥10% BSA, onset ≥3 years, UK Working Party criteria). Analyses will emulate randomized comparisons using registry treatment start visits and available physician- and patient-reported measures.
Who should consider this trial
Good fit: Adults with chronic moderate-to-severe atopic dermatitis (EASI ≥16, ≥10% BSA involved, onset ≥3 years, meeting UK Working Party criteria) who are captured in the TREATgermany registry and start either upadacitinib or dupilumab are eligible.
Not a fit: Patients with mild disease (EASI <16), disease onset under 3 years, or contraindications to upadacitinib or dupilumab are unlikely to be included or benefit from the comparisons made here.
Why it matters
Potential benefit: If successful, this work could confirm which medication produces greater short-term skin clearance in routine care and add insight on patient-reported symptoms and quality of life.
How similar studies have performed: The randomized Heads Up trial found greater short-term skin-clearing with upadacitinib versus dupilumab at week 16, and this analysis aims to replicate that result in real-world registry data while adding patient-reported measures.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dresden, Saxony
- Center for Evidence Based Health Care — Dresden, Saxony, Germany (Recruiting)
Study contacts
- Principal investigator: Jochen M Schmitt — Center for Evidence-based Healthcare, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden
- Study coordinator: Thomas Birkner
- Email: Thomas.Birkner@ukdd.de
- Phone: +4935145889937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.