Atopic DermatitisERUDANCT05989932
Real-world Experience on the Use of Upadacitinib in the Treatment of Moderate-severe Adult Atopic Dermatitis (ERUDA)
An observational study of Atopic Dermatitis, run by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
Trial summary
Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe atopic dermatitis 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
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2021to 19 Apr 2024
- How long will I take part?
- 12 Weeks
- 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: The nature of the study is descriptive. Each center is committed to enlist consecutively all adult patients diagnosed with moderate-severe atopic dermatitis treated with upadacitinib
Who may be able to join
- Age 18 years
- Signature of informed consent
- Diagnosis of moderate and/or severe DA by a dermatologist specialist
- Approval of the compassionate use of upadacitinib
Who cannot join
- Patient unable to give informed consent prior to any collection procedure study data
- unable to complete the procedures required for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esperienza Real-world Sull'Uso di Upadacitinib Nel Trattamento Della Dermatite Atopica Moderata-severa Dell'Adulto
Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe atopic dermatitis
Read the detailed description
Atopic dermatitis (DA) is a chronic-recurrent inflammatory skin disease with high prevalence in children. Clinical remission is frequently observed during or after childhood although it may persist and/or recur, even after long and transient remission, in adulthood. In addition, in some patients the DA begins in adulthood: in these cases, we speak of DA adult-onset. In addition to the diagnostic framework, it is also important in clinical practice to assess the severity of the disease on which the choice of treatment is based, which will also take into account other factors such as: possible comorbidities, Previously performed therapies and patient needs. For the management of moderate-severe forms of atopic dermatitis topical drugs, phototherapy, traditional immunomodulating drugs and a biological drug are currently available. Compared to other chronic inflammatory skin diseases the therapeutic paraphernalia should be considered limited, with most systemic drugs that have no indication for the treatment of DA (off-label use).
In the pipeline there are numerous drugs that have reached an advanced stage of development. These include upadacitinib, a new-generation oral drug (small molecule) that selectively inhibits the signal mediated by Janus kinases 1 (JAK-1), has recently received approval for treatment of DA by EMA and AIFA to begin compassionate use of patients deemed contraindicated, intolerant, and/or non-responsive to traditional systemic therapies and biological therapy.
- Evaluation of the effectiveness of upadacitinib using the EASI score Secondary objectives
- Evaluation of the safety profile of upadacitinib
- Predictive factors of treatment response
- Assessment of patient quality of life
- Conditions
- Atopic Dermatitis
- Being tested
- 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.
UpadacitinibOther
Real-world on the use of Upadacitinib
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology life quality index (DLQI)
Assessment of the patient's quality of life. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life) --> 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect
Measured: from enrollment up to 48 weeks
Patient-oriented eczema measure (POEM)
The Patient Oriented Eczema Measure (POEM) is a simple, validated self-report questionnaire used for monitoring atopic eczema severity. It records seven symptoms shown to be important to patients, like itchy, sleep, bleeding ect.. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; Every day = 4. The meaning is: 0 to 2 = Clear or almost clear; 3 to 7 = Mild eczema; 8 to 16 = Moderate eczema; 17 to 24 = Severe eczema; 25 to 28 = Very severe eczema.
Measured: From enrollment up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Dec 2021
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
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.
- 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
- Other
- Enrolment
- 146 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989932
- Sponsor's protocol ID
- SID02
- Acronym
- ERUDA
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2023
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esperienza Real-world Sull'Uso di Upadacitinib Nel Trattamento Della Dermatite Atopica Moderata-severa Dell'Adulto
- ClinicalTrials.gov ID
- NCT05989932
- Acronym / sponsor ID
- ERUDA / SID02
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente TrasmesseUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 14 Aug 2023 (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.
Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe atopic dermatitis
Detailed description
Atopic dermatitis (DA) is a chronic-recurrent inflammatory skin disease with high prevalence in children. Clinical remission is frequently observed during or after childhood although it may persist and/or recur, even after long and transient remission, in adulthood. In addition, in some patients the DA begins in adulthood: in these cases, we speak of DA adult-onset. In addition to the diagnostic framework, it is also important in clinical practice to assess the severity of the disease on which the choice of treatment is based, which will also take into account other factors such as: possible comorbidities, Previously performed therapies and patient needs. For the management of moderate-severe forms of atopic dermatitis topical drugs, phototherapy, traditional immunomodulating drugs and a biological drug are currently available. Compared to other chronic inflammatory skin diseases the therapeutic paraphernalia should be considered limited, with most systemic drugs that have no indication for the treatment of DA (off-label use).
In the pipeline there are numerous drugs that have reached an advanced stage of development. These include upadacitinib, a new-generation oral drug (small molecule) that selectively inhibits the signal mediated by Janus kinases 1 (JAK-1), has recently received approval for treatment of DA by EMA and AIFA to begin compassionate use of patients deemed contraindicated, intolerant, and/or non-responsive to traditional systemic therapies and biological therapy.
- Evaluation of the effectiveness of upadacitinib using the EASI score Secondary objectives
- Evaluation of the safety profile of upadacitinib
- Predictive factors of treatment response
- Assessment of patient quality of life
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The nature of the study is descriptive. Each center is committed to enlist consecutively all adult patients diagnosed with moderate-severe atopic dermatitis treated with upadacitinib
Key inclusion criteria (4 listed)
- Age 18 years
- Signature of informed consent
- Diagnosis of moderate and/or severe DA by a dermatologist specialist
- Approval of the compassionate use of upadacitinib
Key exclusion criteria (2 listed)
- Patient unable to give informed consent prior to any collection procedure study data
- unable to complete the procedures required for the study
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 |
|---|---|---|
| UpadacitinibReal-world on the use of Upadacitinib | Other | – |
Primary outcome
Dermatology life quality index (DLQI)
Time frame: from enrollment up to 48 weeks
Assessment of the patient's quality of life. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life) --> 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect
Patient-oriented eczema measure (POEM)
Time frame: From enrollment up to 48 weeks
The Patient Oriented Eczema Measure (POEM) is a simple, validated self-report questionnaire used for monitoring atopic eczema severity. It records seven symptoms shown to be important to patients, like itchy, sleep, bleeding ect.. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; Every day = 4. The meaning is: 0 to 2 = Clear or almost clear; 3 to 7 = Mild eczema; 8 to 16 = Moderate eczema; 17 to 24 = Severe eczema; 25 to 28 = Very severe eczema.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 17 Jul 2025. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dermatology life quality index (DLQI) (time frame: from enrollment up to 48 weeks). The study lists 2 primary outcomes in all. 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 17 Jul 2025.