Atopic DermatitisNCT05442645
A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan
An observational study of Atopic Dermatitis, run by Sanofi at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2022to 18 Jun 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AD patients, who are eligible for dupilumab reimbursement in Taiwan
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Investigational site-National Taiwan University Hospital
Taipei, Taiwan
About this study
Official title: Observational Study of Atopic Dermatitis Patients 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).
Read more
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
Read the detailed description
1 year
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Used regimens
Measured: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reason for initiation of new treatments
Measured: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Concomitant therapies
Measured: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Treatment durations
Measured: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reasons for discontinuation and/or switching
Measured: At baseline (Day 1)
Secondary outcomes (26)
Characterization of the patients who receive dupilumab for AD: Medical history
Measured: At baseline (Day 1)
Characterization of the patients who receive dupilumab for AD: Socio-demographic data
Measured: 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)
Measured: At baseline (Day 1)
Characterization of the patients who receive dupilumab for AD: Reason for initiation of dupilumab
Measured: At baseline (Day 1)
Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (Asthma Control Questionnaire (ACQ-5))
Measured: At baseline (Day 1)
Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (22-item Sino-Nasal Outcome Test (SNOT-22))
Measured: At baseline (Day 1)
Characterization of real-world use patterns of dupilumab for AD: Dupilumab dose regimens used over the study, and the duration with each regimen
Measured: Up to 12 months
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
Measured: Up to 12 months
Characterization of real-world use patterns of dupilumab for AD: Percent discontinuing dupilumab, including temporary or permanent discontinuation; reasons for discontinuation
Measured: Up to 12 months
Characterization of real-world use patterns of dupilumab for AD: Longest duration of use
Measured: Up to 12 months
Characterization of real-world use patterns of dupilumab for AD: Number of gaps in dupilumab treatment and longest gap length
Measured: Up to 12 months
Characterization of real-world use patterns of dupilumab for AD: Concomitant therapies taken for AD
Measured: Up to 12 months
Effectiveness of dupilumab: change from baseline in Eczema Area and Severity Index (EASI)
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in body surface area (of AD involvement) (BSA)
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Investigator global assessment scale (IGA)
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Scoring of Atopic Dermatitis (SCORAD)
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Patient-Oriented Eczema Measure (POEM)
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Atopic Dermatitis Control Tools (ADCT)
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Pruritus Numerical Rating Scale (NRS)
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Sleep NRS
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Dermatology Life Quality Index (DLQI)
Measured: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab in relevant comorbid conditions: change in Juniper Asthma Control Questionnaire (ACQ-5) from the first reported time point of Asthma
Measured: Day 0 to Month 12
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
Measured: Day 0 to Month 12
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)
Measured: Day 0 to Month 12
Safety: Number of patients with at least 1 adverse event (AE)
Measured: Day 0 to Month 12
Safety: Annualized event rates of AEs
Measured: Day 0 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start20 Jul 2022
- Primary completion27 Jun 2023
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442645
- Sponsor's protocol ID
- OBS17337
- Other IDs
- U1111-1269-6392
- Status last verified
- Jul 2024
- First submitted
- 22 Jun 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Atopic Dermatitis Patients Treated With Dupilumab in Taiwan
- ClinicalTrials.gov ID
- NCT05442645
- Acronym / sponsor ID
- OBS17337
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
1 year
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AD patients, who are eligible for dupilumab reimbursement in Taiwan
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Used regimens
Time frame: At baseline (Day 1)
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)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Concomitant therapies
Time frame: At baseline (Day 1)
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Treatment durations
Time frame: At baseline (Day 1)
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)
26 secondary outcomes
Characterization of the patients who receive dupilumab for AD: Medical history
Time frame: At baseline (Day 1)
Characterization of the patients who receive dupilumab for AD: Socio-demographic data
Time frame: 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)
Time frame: At baseline (Day 1)
Characterization of the patients who receive dupilumab for AD: Reason for initiation of dupilumab
Time frame: At baseline (Day 1)
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)
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)
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
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
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
Characterization of real-world use patterns of dupilumab for AD: Longest duration of use
Time frame: Up to 12 months
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
Characterization of real-world use patterns of dupilumab for AD: Concomitant therapies taken for AD
Time frame: Up to 12 months
Effectiveness of dupilumab: change from baseline in Eczema Area and Severity Index (EASI)
Time frame: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in body surface area (of AD involvement) (BSA)
Time frame: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Investigator global assessment scale (IGA)
Time frame: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Scoring of Atopic Dermatitis (SCORAD)
Time frame: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Patient-Oriented Eczema Measure (POEM)
Time frame: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Atopic Dermatitis Control Tools (ADCT)
Time frame: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Pruritus Numerical Rating Scale (NRS)
Time frame: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Sleep NRS
Time frame: Day 0, Months 3, 6, 9 and 12
Effectiveness of dupilumab: change from baseline in Dermatology Life Quality Index (DLQI)
Time frame: Day 0, Months 3, 6, 9 and 12
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
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
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
Safety: Number of patients with at least 1 adverse event (AE)
Time frame: Day 0 to Month 12
Safety: Annualized event rates of AEs
Time frame: Day 0 to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Sanofi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Used regimens (time frame: At baseline (Day 1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.