Atopic DermatitisPhase 4NCT05285839
Dupixent and Narrowband UVB for Atopic Dermatitis
A Phase 4 study testing Dupixent in people with Atopic Dermatitis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupixent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 15 Dec 2024
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or female adult ≥ 18 years of age;
- Diagnosis of moderate to severe atopic dermatitis as defined at baseline by:
- EASI score of 16 or greater,
- IGA score of 3 or greater
- BSA of 10% or greater,
Who cannot join
- Subjects with previous exposure to dupilumab.
- Known or suspected hypersensitivity to dupilumab or any of its excipients.
- History of photosensitivity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Eczema Treatment Center of New Jersey
East Windsor, New Jersey, 08520
Elise Nelson, 609-443-4500 ext. 1402, enelson@windsordermatology.com
Jerry Bagel, MD
About this study
Official title: Single Center, Pilot Study to Evaluate the Effectiveness and Safety of Dupilumab in Combination With Narrowband UVB (nUVB) Phototherapy in the Treatment of Moderate-to-Severe Atopic Dermatitis
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
Read the detailed description
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
- Conditions
- Atopic Dermatitis
- Being tested
- Dupixent
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupixentDrug
dupilumab 300mg
| Study group | Role | What they receive |
|---|---|---|
| Dupixent and Narrowband UVB | Experimental | Dupixent and Narrowband UVB Receives: Drug: Dupixent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators Global Assessment Score of score of 0 or 1
Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start19 Apr 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285839
- Sponsor's protocol ID
- ETC01
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Pilot Study to Evaluate the Effectiveness and Safety of Dupilumab in Combination With Narrowband UVB (nUVB) Phototherapy in the Treatment of Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05285839
- Acronym / sponsor ID
- ETC01
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 18 Mar 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.
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
Detailed description
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupixent and Narrowband UVB | Experimental | Drug: DupixentDupixent and Narrowband UVB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female adult ≥ 18 years of age;
- Diagnosis of moderate to severe atopic dermatitis as defined at baseline by:
Key exclusion criteria (3 listed)
- Subjects with previous exposure to dupilumab.
- Known or suspected hypersensitivity to dupilumab or any of its excipients.
- History of photosensitivity.
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 |
|---|---|---|
| Dupixentdupilumab 300mg | Drug | Dupixent and Narrowband UVB |
Primary outcome
Investigators Global Assessment Score of score of 0 or 1
Time frame: 12 weeks
Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 Dupixent in people with Atopic Dermatitis, run by Psoriasis Treatment Center of Central New Jersey 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 5 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: looking for participants now, as of the sponsor's last update on 15 Mar 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise Nelson (6094434500, enelson@windsordermatology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigators Global Assessment Score of score of 0 or 1 (time frame: 12 weeks). 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 15 Mar 2024.