Atopic DermatitisDRSNCT03411837
Dupilumab Phase 4 Study
An observational study of Atopic Dermatitis, run by Northwestern University at 1 site in United States.
Trial summary
The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 31 Aug 2019
- 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
- Child, Adult, Older adult
Study population: Patients diagnosed with moderate-to-severe atopic dermatitis on dupilumab
Who may be able to join
- Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care.
- Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD.
Who cannot join
- Patients not on dupilumab
- Those who do not comply with the study requirements
- Those who do not provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Dupilumab Registry Study
The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.
Read the detailed description
The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab
- Keywords
- Atopic Dermatitis, dupilumab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabBiological
Also called Dupixent
Biologic (monoclonal antibody)
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Patients with moderated-to-severe atopic dermatitis who are receiving dupilumab as a standard of care Receives: Biological: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantified Itch Survey
Measured: 1 to 3 months
Quantified Sleep Survey
Measured: 1 to 3 months
Quantified Quality of Life Survey
Measured: 1 to 3 months
Secondary outcomes (3)
Occurrence of any AEs by 24 months
Will be determined based off of patient reported safety events
Measured: 24 months
Occurrence of any infections by 24 months
Will be determined based off of patient reported safety events
Measured: 24 months
Occurrence of any SAEs by 24 months
Will be determined based off of patient reported safety events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start16 Oct 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Investigator moved from institution.
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 Northwestern UniversityThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Silverberg, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411837
- Sponsor's protocol ID
- STU00088226
- Acronym
- DRS
- Status last verified
- Oct 2021
- First submitted
- 13 Nov 2017
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab Registry Study
- ClinicalTrials.gov ID
- NCT03411837
- Acronym / sponsor ID
- DRS / STU00088226
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, dupilumab
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator moved from institution.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 26 Jan 2018 (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.
The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.
Detailed description
The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | – | Biological: DupilumabPatients with moderated-to-severe atopic dermatitis who are receiving dupilumab as a standard of care |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with moderate-to-severe atopic dermatitis on dupilumab
Key inclusion criteria (2 listed)
- Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care.
- Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD.
Key exclusion criteria (3 listed)
- Patients not on dupilumab
- Those who do not comply with the study requirements
- Those who do not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentBiologic (monoclonal antibody) | Biological | Dupilumab |
Primary outcome
Quantified Itch Survey
Time frame: 1 to 3 months
Quantified Sleep Survey
Time frame: 1 to 3 months
Quantified Quality of Life Survey
Time frame: 1 to 3 months
3 secondary outcomes
Occurrence of any AEs by 24 months
Time frame: 24 months
Occurrence of any infections by 24 months
Time frame: 24 months
Occurrence of any SAEs by 24 months
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Investigator moved from institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Northwestern University at 1 site in United States.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Oct 2021. 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 United States. 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 was stopped early (reason given: Investigator moved from institution.). Results are not available in the source record.
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?
Quantified Itch Survey (time frame: 1 to 3 months). The study lists 3 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 12 Oct 2021.