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

Dermatitis Atopic Clinical Trial

— AD-impaCT  

Official title:

A Real-World Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Patients Receiving Dupilumab Therapy, With Atopic Dermatitis Control Tool in Gulf Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214326
• Other study ID #: OBS17399
• Secondary ID: U1111-1269-6618O
• Status: Completed
• Start date: January 18, 2022
• Est. completion date: March 21, 2023

Study information

• Verified date: November 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

24 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Atopic
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Kuwait	Investigational site Kuwait	Kuwait
Saudi Arabia	Investigational site Saudi Arabia	Saudi Arabia
United Arab Emirates	Investigational site United Arab Emirates	United Arab Emirates

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Kuwait,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT	ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.	At weeks 4, 12, and 24
Secondary	Percentages (%) of patients with ADCT score less than 7	ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.	At weeks 4 and 12
Secondary	Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)	SCORAD is used to assess the extent and severity of AD. Extent and severity of AD as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease).	At week 24
Secondary	Mean change in SCORAD	SCORAD is used to assess the extent and severity of AD. Extent and severity of AD as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease).	From baseline (week 0) to week 24
Secondary	Number of patients with at least one type-2 inflammation comorbidity	Comorbidities related to type-2 inflammation as (allergic rhinitis, bronchial asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis).	Baseline (week 0) to week 24
Secondary	Adverse events (AEs) related to dupilumab use	Number of patients experiencing adverse events (AEs) related to dupilumab use.	Baseline (week 0) to week 24
Secondary	Serious adverse events (SAEs) related to dupilumab use	Number of patients experiencing serious adverse events (SAEs) related to dupilumab use.	Baseline (week 0) to week 24
Secondary	Adverse events of special interest (AESI) related to dupilumab use	Number of patients experiencing adverse events of special interest (AESI) related to dupilumab use. An AESI is an adverse event (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is required.	Baseline (week 0) to week 24
Secondary	Treatment interruption due to any adverse drug reaction (ADR), AE, SAE, or AESI	Number of patients experiencing treatment interruption due to any adverse drug reaction, AE, SAE, or AESI. An AESI is an adverse event (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is required.	Baseline (week 0) to week 24
Secondary	Treatment satisfaction: Number of patients achieving patient global assessment of treatment effect (PGATE) level very good	PGATE is an assessment tool used to rate the treatment effect of the medication on atopic dermatitis (AD), with scores ranging from 0 to 4 (0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent), i.e., higher score indicated higher treatment effect.	At week 24