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Completed

NCT Number: NCT05442645

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational site-National Taiwan University Hospital

Taipei, Taiwan, China

About this study

1 year

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

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.

Treatment and study plan

Primary outcomes

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

    Time frame: At baseline (Day 1)

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

    Time frame: At baseline (Day 1)

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

    Time frame: At baseline (Day 1)

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

    Time frame: At baseline (Day 1)

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

    Time frame: At baseline (Day 1)

Secondary outcomes

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

    Time frame: At baseline (Day 1)

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

    Time frame: At baseline (Day 1)

  3. 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)

    Time frame: At baseline (Day 1)

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

    Time frame: At baseline (Day 1)

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

    Time frame: At baseline (Day 1)

  6. Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (22-item Sino-Nasal Outcome Test (SNOT-22))

    Time frame: At baseline (Day 1)

  7. Characterization of real-world use patterns of dupilumab for AD: Dupilumab dose regimens used over the study, and the duration with each regimen

    Time frame: Up to 12 months

  8. 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

    Time frame: Up to 12 months

  9. Characterization of real-world use patterns of dupilumab for AD: Percent discontinuing dupilumab, including temporary or permanent discontinuation; reasons for discontinuation

    Time frame: Up to 12 months

  10. Characterization of real-world use patterns of dupilumab for AD: Longest duration of use

    Time frame: Up to 12 months

  11. Characterization of real-world use patterns of dupilumab for AD: Number of gaps in dupilumab treatment and longest gap length

    Time frame: Up to 12 months

  12. Characterization of real-world use patterns of dupilumab for AD: Concomitant therapies taken for AD

    Time frame: Up to 12 months

  13. Effectiveness of dupilumab: change from baseline in Eczema Area and Severity Index (EASI)

    Time frame: Day 0, Months 3, 6, 9 and 12

  14. Effectiveness of dupilumab: change from baseline in body surface area (of AD involvement) (BSA)

    Time frame: Day 0, Months 3, 6, 9 and 12

  15. Effectiveness of dupilumab: change from baseline in Investigator global assessment scale (IGA)

    Time frame: Day 0, Months 3, 6, 9 and 12

  16. Effectiveness of dupilumab: change from baseline in Scoring of Atopic Dermatitis (SCORAD)

    Time frame: Day 0, Months 3, 6, 9 and 12

  17. Effectiveness of dupilumab: change from baseline in Patient-Oriented Eczema Measure (POEM)

    Time frame: Day 0, Months 3, 6, 9 and 12

  18. Effectiveness of dupilumab: change from baseline in Atopic Dermatitis Control Tools (ADCT)

    Time frame: Day 0, Months 3, 6, 9 and 12

  19. Effectiveness of dupilumab: change from baseline in Pruritus Numerical Rating Scale (NRS)

    Time frame: Day 0, Months 3, 6, 9 and 12

  20. Effectiveness of dupilumab: change from baseline in Sleep NRS

    Time frame: Day 0, Months 3, 6, 9 and 12

  21. Effectiveness of dupilumab: change from baseline in Dermatology Life Quality Index (DLQI)

    Time frame: Day 0, Months 3, 6, 9 and 12

  22. Effectiveness of dupilumab in relevant comorbid conditions: change in Juniper Asthma Control Questionnaire (ACQ-5) from the first reported time point of Asthma

    Time frame: Day 0 to Month 12

  23. 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

    Time frame: Day 0 to Month 12

  24. 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)

    Time frame: Day 0 to Month 12

  25. Safety: Number of patients with at least 1 adverse event (AE)

    Time frame: Day 0 to Month 12

  26. Safety: Annualized event rates of AEs

    Time frame: Day 0 to Month 12

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Observational Study of Atopic Dermatitis Patients Treated With Dupilumab in Taiwan

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 5, 2022
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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