Dermatitis AtopicAD-impaCTNCT05214326
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
An observational study of Dermatitis Atopic, run by Sanofi at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dermatitis Atopic
- How many people
- 187 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 Jan 2022to 21 Mar 2023
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with moderate to severe atopic dermatitis, initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Arab Emirates1 site
Investigational site United Arab Emirates
United Arab Emirates
About this study
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
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.
Read more
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.
Read the detailed description
24 weeks
- Conditions
- Dermatitis Atopic
- 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 moderate to severe atopic dermatitis | Participants initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 24
Secondary outcomes (10)
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.
Measured: At weeks 4, 12, and 24
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.
Measured: At weeks 4 and 12
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).
Measured: At week 24
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).
Measured: From baseline (week 0) to week 24
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).
Measured: Baseline (week 0) to week 24
Adverse events (AEs) related to dupilumab use
Number of patients experiencing adverse events (AEs) related to dupilumab use.
Measured: Baseline (week 0) to week 24
Serious adverse events (SAEs) related to dupilumab use
Number of patients experiencing serious adverse events (SAEs) related to dupilumab use.
Measured: Baseline (week 0) to week 24
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.
Measured: Baseline (week 0) to week 24
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.
Measured: Baseline (week 0) to week 24
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.
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start18 Jan 2022
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis AtopicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trial Transparency Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214326
- Sponsor's protocol ID
- OBS17399
- Other IDs
- U1111-1269-6618, OBS17399
- Acronym
- AD-impaCT
- Status last verified
- Nov 2023
- First submitted
- 23 Dec 2021
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05214326
- Acronym / sponsor ID
- AD-impaCT / OBS17399
- Conditions
- Dermatitis Atopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 28 Jan 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 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.
Detailed description
24 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with moderate to severe atopic dermatitis | – | –Participants initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with moderate to severe atopic dermatitis, initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.
Key inclusion criteria (6 listed)
- Having moderate to severe atopic dermatitis:
- 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.
Key exclusion criteria (6 listed)
- 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.
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
Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)
Time frame: At week 24
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.
10 secondary outcomes
Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT
Time frame: At weeks 4, 12, and 24
Percentages (%) of patients with ADCT score less than 7
Time frame: At weeks 4 and 12
Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)
Time frame: At week 24
Mean change in SCORAD
Time frame: From baseline (week 0) to week 24
Number of patients with at least one type-2 inflammation comorbidity
Time frame: Baseline (week 0) to week 24
Adverse events (AEs) related to dupilumab use
Time frame: Baseline (week 0) to week 24
Serious adverse events (SAEs) related to dupilumab use
Time frame: Baseline (week 0) to week 24
Adverse events of special interest (AESI) related to dupilumab use
Time frame: Baseline (week 0) to week 24
Treatment interruption due to any adverse drug reaction (ADR), AE, SAE, or AESI
Time frame: Baseline (week 0) to week 24
Treatment satisfaction: Number of patients achieving patient global assessment of treatment effect (PGATE) level very good
Time frame: At week 24
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 29 Nov 2023.
- 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.
Trial Transparency Clinical Sciences & Operations study director
Sanofi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis Atopic, run by Sanofi at 3 sites in 3 countries.
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 6 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kuwait, Saudi Arabia, United Arab Emirates. 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?
Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT) (time frame: At week 24). 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 29 Nov 2023.