The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis

NCT07467564 | Recruiting FDA Drug

• 2 other identifiers: OBS18647U1111-1316-0051
• Study Type: observational
• Target: 184
• Locations: 2 countries
• Sites: 2

Brief 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. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline to up to Week 24

Secondary Outcomes (4)

• Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score.

  Baseline to week 24

• Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID)

  Week 24

• Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p)

  Baseline to up to Week 24

• Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p

  At Baseline and Week 24.

Interventions

Dupilumab DRUG

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

Saudi Medical Services (Medical Fakeeh)

Jeddah, 21331, Saudi Arabia

RECRUITING

NMC Specialty Hospital LTD

Abu Dhabi, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): May 24, 2027
• Study Completion (Estimated): May 24, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

SA (1); AE (1)