Dermatitis, AtopicJAKIGREATNCT04761978
Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis
An observational study of Dermatitis, Atopic, run by University Hospital, Lille at 1 site in France.
Trial summary
The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Sep 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients assessed by French members of the Groupe de Recherche sur l'Eczema Atopique.
Who may be able to join
- Adults
- moderate to severe atopic dermatitis
- treated by JAK inhibitors between december 2020 and september 2021
- inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy
- ineligibility to French ongoing clinical trials
Who cannot join
- Children
- mild atopic dermatitis
- eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy
- eligibility to French ongoing clinical trials
- patients' opposition for the use of their records
- follow up <3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort
The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort
- Conditions
- Dermatitis, Atopic
- Keywords
- Effectiveness, Safety, JAK inhibitors, Atopic dermatitis, Adults
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in Eczema Area and Severity Index (EASI)
Measured: At 3 months
Secondary outcomes (6)
SCORing Atopic Dermatitis (SCORAD)
Measured: at baseline and at 3 months
Investigator's Global Assessment (IGA)
Measured: at baseline and at 3 months
Dermatology Life Quality Index (DLQI)
Measured: at baseline and at 3 months
patient-reported pruritus score from 0 to 10
Measured: at baseline and at 3 months
patient-reported sleep loss from 0 to 10
Measured: at baseline and at 3 months
Adverse effects (biological and clinical)
Measured: at baseline and at 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine Staumont-Salle, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761978
- Sponsor's protocol ID
- NI_2021_01
- Acronym
- JAKIGREAT
- Status last verified
- May 2026
- First submitted
- 15 Feb 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort
- ClinicalTrials.gov ID
- NCT04761978
- Acronym / sponsor ID
- JAKIGREAT / NI_2021_01
- Conditions
- Dermatitis, Atopic
- Keywords
- Effectiveness, Safety, JAK inhibitors, Atopic dermatitis, Adults
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Feb 2021 (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 aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assessed by French members of the Groupe de Recherche sur l'Eczema Atopique.
Key inclusion criteria (5 listed)
- Adults
- moderate to severe atopic dermatitis
- treated by JAK inhibitors between december 2020 and september 2021
- inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy
- ineligibility to French ongoing clinical trials
Key exclusion criteria (6 listed)
- Children
- mild atopic dermatitis
- eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy
- eligibility to French ongoing clinical trials
- patients' opposition for the use of their records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
reduction in Eczema Area and Severity Index (EASI)
Time frame: At 3 months
6 secondary outcomes
SCORing Atopic Dermatitis (SCORAD)
Time frame: at baseline and at 3 months
Investigator's Global Assessment (IGA)
Time frame: at baseline and at 3 months
Dermatology Life Quality Index (DLQI)
Time frame: at baseline and at 3 months
patient-reported pruritus score from 0 to 10
Time frame: at baseline and at 3 months
patient-reported sleep loss from 0 to 10
Time frame: at baseline and at 3 months
Adverse effects (biological and clinical)
Time frame: at baseline and at 3 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Delphine Staumont-Salle, MD,PhD principal investigator
University Hospital, Lille
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 Dermatitis, Atopic, run by University Hospital, Lille at 1 site in France.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 22 May 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 France. 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 withdrawn before enrolling participants, so there are no results.
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?
reduction in Eczema Area and Severity Index (EASI) (time frame: At 3 months). 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 22 May 2026.