Atopic DermatitisRe-HU-TREATNCT06937788
Replication of the Heads Up Atopic Dermatitis Trial With Registry Data
An observational study of Atopic Dermatitis, run by Technische Universität Dresden at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Upadacitinib and Dupilumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- 2 Aug 2021to 26 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with moderate to severe atopic dermatitis enrolled in the TREATgermany disease registry who are candidates for systemic therapy.
Who may be able to join
- 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
Who cannot join
- contraindications according to upadacitinib or dupilumab labeling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data
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).
Read the detailed description
Atopic dermatitis (AD) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and negative consequences on quality of life. The goal of this study is the replication of the primary outcome (Eczema Area and Severity Index (EASI) 75 at week 16) of the Heads Up trial and the evaluation of the patient reported outcomes (Patient-oriented Eczema Measure (POEM), Dermatologic Quality of Life Index (DLQI) and Recap of Atopic Eczema (RECAP)) that were not assessed in the Heads Up trial but are part of the recommendations by the Harmonising Outcome Measures for Eczema (HOME) initiative (Williams, HC, Schmitt, J, Thomas, KS et al (2022) doi:10.1016\j.jaci.2022.03.017) regarding core outcome sets in atopic dermatitis clinical trials. The core outcome set as defined by HOME encompasses the following domains (core outcome instruments): clinical signs (EASI), patient-reported symptoms (POEM and Peak Itch), long term control (RECAP) and quality of life (DLQI). The data basis is the TREATgermany registry (https://treatgermany.org/). TREATgermany is a national clinical registry for patients with moderate to severe AD. The physician and patient-reported outcomes are collected in about 60 clinics and private practices during routine care. Data of more than 2,400 patients is currently documented.
- Conditions
- Atopic Dermatitis
- Being tested
- Upadacitinib, Dupilumab
- Keywords
- observational, target trial emulation, dupilumab, upadacitinib
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
30 mg tablet daily
DupilumabBiological
300 mg injection every other week
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib (treatment group) | Not described Receives: Drug: Upadacitinib | |
| Dupilumab (active comparator) | Not described Receives: Biological: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
POEM
Mean POEM change
Measured: baseline to month 6
Secondary outcomes (6)
DLQI
Mean DLQI change
Measured: from baseline to month 6
RECAP
Mean RECAP change
Measured: from baseline to month 6
EASI
Mean EASI change
Measured: from baseline to month 6
NRS Itch (past 3 days)
Mean NRS Itch (past 3 days) change
Measured: from baseline to month 6
NRS sleeping problems (past 3 days)
Mean NRS sleeping problems (past 3 days) change
Measured: from baseline to month 6
EASI 75
EASI 75 change
Measured: from baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start2 Aug 2021
- Primary completion30 Jun 2026
- Study completion26 Aug 2026
Why it stopped: Recruitment targets (sample size) could not be met within the planned time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen M Schmitt, Principal investigator, Center for Evidence-based Healthcare, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937788
- Sponsor's protocol ID
- TTE_101_TREATGer
- Acronym
- Re-HU-TREAT
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: Pseudonymized data can be shared after receipt of data request outlining research question and data/variables needed and approval by TREATgermany prinicipal investigators.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data
- ClinicalTrials.gov ID
- NCT06937788
- Acronym / sponsor ID
- Re-HU-TREAT / TTE_101_TREATGer
- Conditions
- Atopic Dermatitis
- Keywords
- observational, target trial emulation, dupilumab, upadacitinib
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment targets (sample size) could not be met within the planned time frame.
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Atopic dermatitis (AD) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and negative consequences on quality of life. The goal of this study is the replication of the primary outcome (Eczema Area and Severity Index (EASI) 75 at week 16) of the Heads Up trial and the evaluation of the patient reported outcomes (Patient-oriented Eczema Measure (POEM), Dermatologic Quality of Life Index (DLQI) and Recap of Atopic Eczema (RECAP)) that were not assessed in the Heads Up trial but are part of the recommendations by the Harmonising Outcome Measures for Eczema (HOME) initiative (Williams, HC, Schmitt, J, Thomas, KS et al (2022) doi:10.1016\j.jaci.2022.03.017) regarding core outcome sets in atopic dermatitis clinical trials. The core outcome set as defined by HOME encompasses the following domains (core outcome instruments): clinical signs (EASI), patient-reported symptoms (POEM and Peak Itch), long term control (RECAP) and quality of life (DLQI). The data basis is the TREATgermany registry (https://treatgermany.org/). TREATgermany is a national clinical registry for patients with moderate to severe AD. The physician and patient-reported outcomes are collected in about 60 clinics and private practices during routine care. Data of more than 2,400 patients is currently documented.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib (treatment group) | – | Drug: Upadacitinib |
| Dupilumab (active comparator) | – | Biological: Dupilumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with moderate to severe atopic dermatitis enrolled in the TREATgermany disease registry who are candidates for systemic therapy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- contraindications according to upadacitinib or dupilumab labeling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upadacitinib30 mg tablet daily | Drug | Upadacitinib (treatment group) |
| Dupilumab300 mg injection every other week | Biological | Dupilumab (active comparator) |
Primary outcome
POEM
Time frame: baseline to month 6
Mean POEM change
6 secondary outcomes
DLQI
Time frame: from baseline to month 6
RECAP
Time frame: from baseline to month 6
EASI
Time frame: from baseline to month 6
NRS Itch (past 3 days)
Time frame: from baseline to month 6
NRS sleeping problems (past 3 days)
Time frame: from baseline to month 6
EASI 75
Time frame: from baseline to month 6
Results and safety
The study was stopped early (reason given: Recruitment targets (sample size) could not be met within the planned time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- TREATgermany websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pseudonymized data can be shared after receipt of data request outlining research question and data/variables needed and approval by TREATgermany prinicipal investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen M Schmitt principal investigator
Center for Evidence-based Healthcare, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment targets (sample size) could not be met within the planned time frame.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POEM (time frame: baseline to month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.