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

NCT05442645 | Completed

• 2 other identifiers: OBS17337U1111-1269-6392
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Used regimens

  At baseline (Day 1)

• Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reason for initiation of new treatments

  At baseline (Day 1)

• Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Concomitant therapies

  At baseline (Day 1)

• Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Treatment durations

  At baseline (Day 1)

• Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reasons for discontinuation and/or switching

  At baseline (Day 1)

Secondary Outcomes (26)

• Characterization of the patients who receive dupilumab for AD: Medical history

  At baseline (Day 1)

• Characterization of the patients who receive dupilumab for AD: Socio-demographic data

  At baseline (Day 1)

• 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)

• Characterization of the patients who receive dupilumab for AD: Reason for initiation of dupilumab

  At baseline (Day 1)

• Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (Asthma Control Questionnaire (ACQ-5))

  At baseline (Day 1)

Study Arms (1)

Participants with AD

Male or female, 18 years or older at the baseline visit initiated treatment with dupilumab for AD, who are eligible for dupilumab reimbursement according to the country-specific prescribing information

Eligibility Criteria

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

Study Population

AD patients, who are eligible for dupilumab reimbursement in Taiwan

You may qualify if:

• 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:
• Phototherapy (psoralen + ultraviolet light A (PUVA) or narrow-band ultraviolet B (nb-UVB) twice a week) more than 3 months, and,
• Two different immunosuppressants (methotrexate, azathioprine, or cyclosporine) more than 3 months respectively before their enrollment in the registry.
• Provided signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational site-National Taiwan University Hospital

Taipei, Taiwan, China

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

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 5, 2022
• Study Start: July 20, 2022
• Primary Completion: June 27, 2023
• Study Completion: June 18, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)