Atopic DermatitisDERMIND-ADNCT07467564
The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Sanofi at 7 sites in 3 countries.
Trial summary
This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab
- How many people
- 184 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 24 Feb 2026to 24 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will recruit participants from AD patients who are already receiving dupilumab treatment (Dupixent®) (within 30 days of enrolment) at the start of the study or for whom the investigator has decided to initiate dupilumab therapy (Dupixent®) independently from the study entry. Eligible patients include those who started dupilumab treatment up to 30 days before enrollment and have a baseline Hospital Anxiety and Depression Scale (HADS-A and/or HADS-D) score of more than (≥) 8 (±3 days from treatment initiation). Each enrolled participant will undergo a 6-month observational study period
Who may be able to join
- Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression.
- Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation
- Participants and/or their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.
Who cannot join
- Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months.
- Participants who are participating in another trial.
- Participants with active chronic or acute infection requiring systemic treatment.
- Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.
- Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.
- Participants on antidepressants/anti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants/anti-anxiety. In addition, those who will use antidepressants/anti-anxiety medications throughout the study will be excluded from the analysis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
7 sites in 3 countries
United Arab Emirates4 sites, 3 recruiting
- Recruiting
Investigational Site: NMC Specialty Hospital LTD
Abu Dhabi
- Recruiting
Investigational Site: Dibba Hospital
Fujairah
- Recruiting
Investigational Site: Ibrahem Bin Hamad Hospital
Ras al-Khaimah
- Active, not recruiting
Investigational Site: Al Qassimi Hospital
Sharjah city
Saudi Arabia2 sites, 1 recruiting
- Recruiting
Investigational Site: Saudi Medical Services (Medical Fakeeh)
Jeddah, 21331
- Active, not recruiting
Investigational Site: King Faisal Specialist Hospital
Jeddah
Qatar1 site
- Active, not recruiting
Investigational Site: Hamad Medical Corporation
Doha
About this study
Official title: The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries
This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety.
Measured: Week 24
Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of depression.
Measured: Week 24
Change from Baseline in HADS Total Score.
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.
Measured: Baseline to up to Week 24
Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score
The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.
Measured: Week 24
Change from Baseline in POEM Total Score.
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.
Measured: Baseline to up to Week 24
Secondary outcomes (4)
Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score.
DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to [≥] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Measured: Baseline to week 24
Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID)
DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to [≥] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Measured: Week 24
Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p)
DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).
Measured: Baseline to up to Week 24
Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p
DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).
Measured: At Baseline 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 posted12 Mar 2026
- Study start24 Feb 2026
- Primary completion24 May 2027 (estimated)
- Study completion24 May 2027 (estimated)
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
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467564
- Sponsor's protocol ID
- OBS18647
- Other IDs
- U1111-1316-0051
- Acronym
- DERMIND-AD
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries
- ClinicalTrials.gov ID
- NCT07467564
- Acronym / sponsor ID
- DERMIND-AD / OBS18647
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 24 May 2027 (estimated)
- Study completion
- 24 May 2027 (estimated)
- First posted
- 12 Mar 2026 (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.
This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will recruit participants from AD patients who are already receiving dupilumab treatment (Dupixent®) (within 30 days of enrolment) at the start of the study or for whom the investigator has decided to initiate dupilumab therapy (Dupixent®) independently from the study entry. Eligible patients include those who started dupilumab treatment up to 30 days before enrollment and have a baseline Hospital Anxiety and Depression Scale (HADS-A and/or HADS-D) score of more than (≥) 8 (±3 days from treatment initiation). Each enrolled participant will undergo a 6-month observational study period
Key inclusion criteria (3 listed)
- Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression.
- Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation
- Participants and/or their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.
Key exclusion criteria (7 listed)
- Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months.
- Participants who are participating in another trial.
- Participants with active chronic or acute infection requiring systemic treatment.
- Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.
- Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.
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 |
|---|---|---|
| DupilumabThis study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice. | Drug | – |
Primary outcome
Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8
Time frame: Week 24
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety.
Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8
Time frame: Week 24
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of depression.
Change from Baseline in HADS Total Score.
Time frame: Baseline to up to Week 24
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.
Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score
Time frame: Week 24
The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.
Change from Baseline in POEM Total Score.
Time frame: Baseline to up to Week 24
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.
4 secondary outcomes
Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score.
Time frame: Baseline to week 24
Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID)
Time frame: Week 24
Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p)
Time frame: Baseline to up to Week 24
Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p
Time frame: At Baseline and Week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- 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.
Trial Transparency email recommended (Toll free for US & Canada) contact
7 sites in 3 countries: 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 7 sites in 3 countries.
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 7 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Arab Emirates, Saudi Arabia, Qatar. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8 (time frame: Week 24). The study lists 5 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 28 Jul 2026.