Atopic DermatitisNCT05527964
A Study to Evaluate the Quality of Life of Male and Female Adult Patients With Severe Refractory Atopic Dermatitis Treated With Dupilumab in Czech Republic
An observational study of Atopic Dermatitis, run by Sanofi at 1 site in Czechia.
Trial summary
Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24. Description of the: Change in disease activity after 16 and 24 weeks Change in subject and family quality of life after 16 and 24 weeks Change in sleep quality after 16 and 24 weeks Change in anxiety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 146 participants
- Where
- 1 siteCzechia
- Study dates
- 30 Dec 2022to 16 Jun 2025
- How long will I take part?
- 28 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: Patients eligible for Dupixent therapy of atopic dermatitis (AD) according to the current summary of product characteristics (SPC) and reimbursement criteria given by the State Institute for Drug Control (SUKL) in Czech Republic
Who may be able to join
- Patient eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL
- Signed informed consent
- 18 years and older (study questionnaires are validated for this age group). Patient is able to follow the prescribed regimen, routine follow-up visits and to fill the questionnaires
Who cannot join
- Patient not eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Investigational Site: Bulovka University Hospital
Prague, 180 81
About this study
Official title: The Influence of Specific Targeted Therapy on Subject and Family Quality of Life, Anxiety, Depression and Sleep Quality in Patients With Severe Refractory Atopic Dermatitis in the Czech Republic
Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24.
Description of the:
- Change in disease activity after 16 and 24 weeks
- Change in subject and family quality of life after 16 and 24 weeks
- Change in sleep quality after 16 and 24 weeks
- Change in anxiety after 16 and 24 weeks
- Change in depression after 16 and 24 weeks
- Safety and tolerability
Read the detailed description
28 weeks
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe refractory atopic dermatitis | Patients eligible for Dupixent therapy of AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The regression coefficient for at least 75% reduction in the Eczema Area and Severity Index score (EASI75) at week 24 adjusted to baseline characteristics predicting the change in EQ-5D utility
Measured: At Week 24
Secondary outcomes (12)
Change in disease activity (Eczema Area and Severity Index (EASI) score)
Measured: At Week 16 and Week 24
Change in subject generic quality of life (European Quality of Life Five Dimension questionnaire (EQ-5D) utility)
Measured: At Week 16 and Week 24
Change in Dermatology Life Quality Index (DLQI score)
Measured: At Week 16 and Week 24
Change in Family Dermatology Life Quality Index (FDLQI score)
Measured: At Week 16
Change in sleep quality (Jenkins Sleep Evaluation Questionnaire (JSEQ) score)
Measured: At Week 16 and Week 24
Change in anxiety (Clinically Useful Anxiety Outcome Scale (CUXOS) score)
Measured: At Week 16 and Week 24
Change in depression (Clinically Useful Depression Outcome Scale (CUDOS) score)
Measured: At Week 16 and Week 24
Total number of adverse events
Measured: At Week 16 and Week 24
Number of serious adverse events (SAEs)
Measured: At Week 16 and Week 24
Number of non-serious adverse events (non-SAEs)
Measured: At Week 16 and Week 24
Total number of discontinuations
Measured: At Week 16 and Week 24
Reasons for discontinuations
Measured: At Week 16 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start30 Dec 2022
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
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 SanofiThe 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
- Prospective
- Enrolment
- 146 participants (actual)
- Target duration
- 28 Weeks
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527964
- Sponsor's protocol ID
- OBS17350
- Other IDs
- U1111-1279-3216
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Specific Targeted Therapy on Subject and Family Quality of Life, Anxiety, Depression and Sleep Quality in Patients With Severe Refractory Atopic Dermatitis in the Czech Republic
- ClinicalTrials.gov ID
- NCT05527964
- Acronym / sponsor ID
- OBS17350
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 6 Sep 2022 (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.
Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24.
Description of the:
- Change in disease activity after 16 and 24 weeks
- Change in subject and family quality of life after 16 and 24 weeks
- Change in sleep quality after 16 and 24 weeks
- Change in anxiety after 16 and 24 weeks
- Change in depression after 16 and 24 weeks
- Safety and tolerability
Detailed description
28 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe refractory atopic dermatitis | – | –Patients eligible for Dupixent therapy of AD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for Dupixent therapy of atopic dermatitis (AD) according to the current summary of product characteristics (SPC) and reimbursement criteria given by the State Institute for Drug Control (SUKL) in Czech Republic
Key inclusion criteria (3 listed)
- Patient eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL
- Signed informed consent
- 18 years and older (study questionnaires are validated for this age group). Patient is able to follow the prescribed regimen, routine follow-up visits and to fill the questionnaires
Key exclusion criteria (2 listed)
- Patient not eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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
The regression coefficient for at least 75% reduction in the Eczema Area and Severity Index score (EASI75) at week 24 adjusted to baseline characteristics predicting the change in EQ-5D utility
Time frame: At Week 24
12 secondary outcomes
Change in disease activity (Eczema Area and Severity Index (EASI) score)
Time frame: At Week 16 and Week 24
Change in subject generic quality of life (European Quality of Life Five Dimension questionnaire (EQ-5D) utility)
Time frame: At Week 16 and Week 24
Change in Dermatology Life Quality Index (DLQI score)
Time frame: At Week 16 and Week 24
Change in Family Dermatology Life Quality Index (FDLQI score)
Time frame: At Week 16
Change in sleep quality (Jenkins Sleep Evaluation Questionnaire (JSEQ) score)
Time frame: At Week 16 and Week 24
Change in anxiety (Clinically Useful Anxiety Outcome Scale (CUXOS) score)
Time frame: At Week 16 and Week 24
Change in depression (Clinically Useful Depression Outcome Scale (CUDOS) score)
Time frame: At Week 16 and Week 24
Total number of adverse events
Time frame: At Week 16 and Week 24
Number of serious adverse events (SAEs)
Time frame: At Week 16 and Week 24
Number of non-serious adverse events (non-SAEs)
Time frame: At Week 16 and Week 24
Total number of discontinuations
Time frame: At Week 16 and Week 24
Reasons for discontinuations
Time frame: At Week 16 and Week 24
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 15 Aug 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
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 Sanofi at 1 site in Czechia.
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 3 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 15 Aug 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 Czechia. 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?
The regression coefficient for at least 75% reduction in the Eczema Area and Severity Index score (EASI75) at week 24 adjusted to baseline characteristics predicting the change in EQ-5D utility (time frame: At Week 24). 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 15 Aug 2025.