A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries

NCT05214326 | Completed

• 2 other identifiers: OBS17399U1111-1269-6618
• Study Type: observational
• Target: 187
• Locations: 3 countries
• Sites: 3

Brief Summary

Primary objective: To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment. Secondary objectives:

• To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment.
• To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24.
• Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD).
• To describe comorbidities related to type 2 inflammation.
• To characterize the safety profile of dupilumab in the local Gulf population.
• To evaluate treatment satisfaction in the local Gulf population.

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)

  ADCT is a questionnaire to assess patient-self-perceived control of their atopic dermatitis (AD) with a total score from 0 to 24; higher scores indicate lower AD control.

  At week 24

Secondary Outcomes (10)

• Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT

  At weeks 4, 12, and 24

• Percentages (%) of patients with ADCT score less than 7

  At weeks 4 and 12

• Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)

  At week 24

• Mean change in SCORAD

  From baseline (week 0) to week 24

• Number of patients with at least one type-2 inflammation comorbidity

  Baseline (week 0) to week 24

Study Arms (1)

Participants with moderate to severe atopic dermatitis

Participants initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.

Eligibility Criteria

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

Study Population

Participants with moderate to severe atopic dermatitis, initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.

You may qualify if:

• Having moderate to severe atopic dermatitis:
• Moderate atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis body surface area (BSA) involvement ≥10%; and ii) Pruritus numerical rating scale (NRS) ≥3, Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline, Investigator's Global Assessment (IGA)=3, or SCORing Atopic Dermatitis (SCORAD) is between 25 and 50.
• Severe atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis BSA involvement ≥10%; ii) Eczema Area and Severity Index (EASI) score ≥20; iii) Investigator's Global Assessment (IGA) score = 4, or SCORAD ≥50.
• Initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.
• Participants and/or his legally approved representatives (LAR, in case of minor subject) agrees to sign an informed consent or an assent.
• Age of 12 years or above.

You may not qualify if:

• Participation in another trial.
• Pregnancy or lactating or planning/intending to be pregnant in the next 6 months.
• Presence of active chronic or acute infection requiring systemic treatment
• Diagnosed active endoparasites infection, or suspected high risk of infection.
• Human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational site Kuwait

Kuwait City, Kuwait

Location

Investigational site Saudi Arabia

Saudi Arabia, Saudi Arabia

Location

Investigational site United Arab Emirates

United Arab Emirates, United Arab Emirates

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

Study Officials

• Trial Transparency Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 28, 2022
• Study Start: January 18, 2022
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

SA (1); KU (1); AE (1)