A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan

Atopic Dermatitis Clinical Trial

Official title:

Observational Study of Atopic Dermatitis Patients Treated With Dupilumab in Taiwan

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05442645
• Other study ID #: OBS17337
• Secondary ID: U1111-1269-6392
• Status: Active, not recruiting
• Start date: July 20, 2022
• Est. completion date: June 28, 2024

Study information

• Verified date: September 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary objective:

To characterize the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment for adult AD patients, who are eligible for dupilumab reimbursement in Taiwan (e.g., used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching).

Secondary objectives:

• To characterize the adult AD patients, who are eligible for dupilumab reimbursement in Taiwan, with respect to their a) medical history, b) socio-demographic, c) disease characteristics, d) comorbid with type 2 diseases [e.g., Asthma, Chronic rhinosinusitis with nasal polyp (CRSwNP)], and e) prior and concomitant treatments of atopic dermatitis

• To assess the effectiveness and safety of dupilumab in adult atopic dermatitis patients, who are eligible for dupilumab reimbursement in Taiwan

• To assess comorbid atopic conditions and effects of dupilumab treatment for comorbid atopic conditions in adult patients, who are eligible for dupilumab reimbursement in Taiwan

• To evaluate the correlation of patient reported outcome [Atopic Dermatitis Control Tool (ADCT)] and physician assessment [Eczema Area and Severity Index (EASI)] from the recruited subjects

Description:

1 year

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, 18 years or older at the baseline visit

• Initiating treatment with dupilumab for AD, who are eligible for dupilumab reimbursement according to the country-specific prescribing information

Note: Patients, who are diagnosed with AD more than 6 months, Eczema Area and Severity Index (EASI) more than or equals to 20. body surface area (of AD involvement) (BSA) more than or equals to 30% and IGA=3-4, may be eligible if they have already initiated treatment with:

1. Phototherapy (psoralen + ultraviolet light A (PUVA) or narrow-band ultraviolet B (nb-UVB) twice a week) more than 3 months, and,

2. Two different immunosuppressants (methotrexate, azathioprine, or cyclosporine) more than 3 months respectively before their enrollment in the registry.

• Provided signed informed consent

Exclusion Criteria:

• Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments

• Patients currently participating in any interventional clinical trial which modifies patient care

• Patients who have a contraindication to dupilumab according to the country-specific prescribing information

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Taiwan	Investigational site number TAIWAN	Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Used regimens		At baseline (Day 1)
Primary	Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reason for initiation of new treatments		At baseline (Day 1)
Primary	Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Concomitant therapies		At baseline (Day 1)
Primary	Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Treatment durations		At baseline (Day 1)
Primary	Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reasons for discontinuation and/or switching		At baseline (Day 1)
Secondary	Characterization of the patients who receive dupilumab for AD: Medical history		At baseline (Day 1)
Secondary	Characterization of the patients who receive dupilumab for AD: Socio-demographic data		At baseline (Day 1)
Secondary	Characterization of the patients who receive dupilumab for AD: Prior and concomitant treatments of AD; percentage who were on dupilumab at the baseline/enrollment visit (Visit 1)		At baseline (Day 1)
Secondary	Characterization of the patients who receive dupilumab for AD: Reason for initiation of dupilumab		At baseline (Day 1)
Secondary	Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (Asthma Control Questionnaire (ACQ-5))		At baseline (Day 1)
Secondary	Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (22-item Sino-Nasal Outcome Test (SNOT-22))		At baseline (Day 1)
Secondary	Characterization of real-world use patterns of dupilumab for AD: Dupilumab dose regimens used over the study, and the duration with each regimen		Up to 12 months
Secondary	Characterization of real-world use patterns of dupilumab for AD: Percentage of patients whose dose (either the frequency of the strength) increased from starting regimen and reasons; percentage whose dose decreased from the starting regimen and reasons		Up to 12 months
Secondary	Characterization of real-world use patterns of dupilumab for AD: Percent discontinuing dupilumab, including temporary or permanent discontinuation; reasons for discontinuation		Up to 12 months
Secondary	Characterization of real-world use patterns of dupilumab for AD: Longest duration of use		Up to 12 months
Secondary	Characterization of real-world use patterns of dupilumab for AD: Number of gaps in dupilumab treatment and longest gap length		Up to 12 months
Secondary	Characterization of real-world use patterns of dupilumab for AD: Concomitant therapies taken for AD		Up to 12 months
Secondary	Effectiveness of dupilumab: change from baseline in Eczema Area and Severity Index (EASI)		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab: change from baseline in body surface area (of AD involvement) (BSA)		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab: change from baseline in Investigator global assessment scale (IGA)		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab: change from baseline in Scoring of Atopic Dermatitis (SCORAD)		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab: change from baseline in Patient-Oriented Eczema Measure (POEM)		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab: change from baseline in Atopic Dermatitis Control Tools (ADCT)		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab: change from baseline in Pruritus Numerical Rating Scale (NRS)		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab: change from baseline in Sleep NRS		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab: change from baseline in Dermatology Life Quality Index (DLQI)		Day 0, Months 3, 6, 9 and 12
Secondary	Effectiveness of dupilumab in relevant comorbid conditions: change in Juniper Asthma Control Questionnaire (ACQ-5) from the first reported time point of Asthma		Day 0 to Month 12
Secondary	Effectiveness of dupilumab in relevant comorbid conditions: change in 22-item Sino-Nasal Outcome Test (SNOT-22) from the first reported time point of Asthma		Day 0 to Month 12
Secondary	Percentage of participants reporting that their comorbid condition got better, and the percentage reporting their condition got worse at each follow-up visit by each specific condition (other than asthma and allergic rhinitis)		Day 0 to Month 12
Secondary	Safety: Number of patients with at least 1 adverse event (AE)		Day 0 to Month 12
Secondary	Safety: Annualized event rates of AEs		Day 0 to Month 12