Atopic DermatitisPhase 4NCT04358224
The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment
A Phase 4 study testing Dupilumab Prefilled Syringe in people with Atopic Dermatitis and Eczema, run by Jonathan A. Bernstein, MD at 1 site in United States.
Trial summary
The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Dupilumab Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 18 Nov 2022
- Phase
- Phase 4
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of adult onset atopic dermatitis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
About this study
The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis
Read the detailed description
The study consists of 9 visits. Duplimab will used in the treatment of adult onset atopic dermatitis. Qualified subjects will receive 5 dupilumab open-label injections. Skin biopsies/ skin strips will be obtained at the beginning and the end of treatment. TARC and IgE levels will be obtained at the beginning and end of treatment. Subjects will complete daily diaries assessing atopic dermatitis symptoms. Patient reported out comes will be completed at each visit
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Dupilumab Prefilled Syringe
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab Prefilled SyringeBiological
Also called dupixent
open-label
| Study group | Role | What they receive |
|---|---|---|
| open-label | Other | open-label Receives: Biological: Dupilumab Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to correlate cutaneous transcriptomes with before and after Dupilumab treatment outcomes in patients who meet the clinical diagnostic criteria for adult onset AD.
Data will be analyzed from skin punch biopsies from active skin lesions and uninvolved skin samples before and after treatment
Measured: after 6 months
Secondary outcomes (1)
To investigate possible influence of Dupilumab on serologic protein biomarkers in patients with adult onset AD
Total IgE, TARC and eotaxin will be compared pre and post treatment
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Sep 2020
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan A. Bernstein, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan A. Bernstein, MD, Bernstein Clinical Research Center
- Investigators
- Jonathan Bernstein, Principal investigator, Bernstein Clinial Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358224
- Sponsor's protocol ID
- R668-AD-1830
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: to be determined
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment
- ClinicalTrials.gov ID
- NCT04358224
- Acronym / sponsor ID
- R668-AD-1830
- Conditions
- Atopic Dermatitis, Eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jonathan A. Bernstein, MDUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 24 Apr 2020 (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 utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis
Detailed description
The study consists of 9 visits. Duplimab will used in the treatment of adult onset atopic dermatitis. Qualified subjects will receive 5 dupilumab open-label injections. Skin biopsies/ skin strips will be obtained at the beginning and the end of treatment. TARC and IgE levels will be obtained at the beginning and end of treatment. Subjects will complete daily diaries assessing atopic dermatitis symptoms. Patient reported out comes will be completed at each visit
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open-label | Other | Biological: Dupilumab Prefilled Syringeopen-label |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- history of adult onset atopic dermatitis
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Dupilumab Prefilled SyringeAlso: dupixentopen-label | Biological | open-label |
Primary outcome
The primary objective of this study is to correlate cutaneous transcriptomes with before and after Dupilumab treatment outcomes in patients who meet the clinical diagnostic criteria for adult onset AD.
Time frame: after 6 months
Data will be analyzed from skin punch biopsies from active skin lesions and uninvolved skin samples before and after treatment
1 secondary outcome
To investigate possible influence of Dupilumab on serologic protein biomarkers in patients with adult onset AD
Time frame: after 6 months
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 8 Feb 2023.
- Individual participant dataSharing planned: Yes. to be determined
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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.
Jonathan Bernstein principal investigator
Bernstein Clinial Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab Prefilled Syringe in people with Atopic Dermatitis and Eczema, run by Jonathan A. Bernstein, MD 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 1 inclusion and 1 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 8 Feb 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of this study is to correlate cutaneous transcriptomes with before and after Dupilumab treatment outcomes in patients who meet the clinical diagnostic criteria for adult onset AD. (time frame: after 6 months). 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 8 Feb 2023.