Atopic DermatitisPhase 4NCT05858619
Molecular Signatures of Cutaneous Dupilumab Response
A Phase 4 study testing Dupilumab in people with Atopic Dermatitis, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions. 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?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Feb 2028
- 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
- 18 years of age or older
- atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7
Who cannot join
- Known pregnancy
- Known immunodeficiencies
- Known parasitic infection -
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
University of California, San Francisco
San Francisco, California, 94143
Jeffrey Cheng, MD, PhD, rashes@ucsf.edu
About this study
This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.
Read the detailed description
This is a one-arm, open-label study to examine the effect of dupilumab. Dupilumab is a FDA-approved medication for the treatment of atopic dermatitis. This study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. Fifteen subjects with moderate to severe atopic dermatitis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.
- Conditions
- Atopic Dermatitis
- Being tested
- 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.
DupilumabDrug
dupilumab 600 mg injection initially and then 300 mg every other week
| Study group | Role | What they receive |
|---|---|---|
| dupilumab treatment | Experimental | Treatment with IL4RA inhibitor Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
Change in EASI score from baseline to 8-12 weeks. Scores range from 0 to 72, with higher scores indicating more severity.
Measured: baseline and 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (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.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Cheng, MD, PhD, Principal investigator, University of California, San FranciscoRaymond Cho, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858619
- Sponsor's protocol ID
- 21-35748
- Status last verified
- Jun 2026
- First submitted
- 4 May 2023
- Last updated
- 4 Jun 2026
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Signatures of Cutaneous Dupilumab Response
- ClinicalTrials.gov ID
- NCT05858619
- Acronym / sponsor ID
- 21-35748
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 15 May 2023 (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.
This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.
Detailed description
This is a one-arm, open-label study to examine the effect of dupilumab. Dupilumab is a FDA-approved medication for the treatment of atopic dermatitis. This study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. Fifteen subjects with moderate to severe atopic dermatitis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dupilumab treatment | Experimental | Drug: DupilumabTreatment with IL4RA inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7
Key exclusion criteria (3 listed)
- Known pregnancy
- Known immunodeficiencies
- Known parasitic infection -
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 |
|---|---|---|
| Dupilumabdupilumab 600 mg injection initially and then 300 mg every other week | Drug | dupilumab treatment |
Primary outcome
Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
Time frame: baseline and 8-12 weeks
Change in EASI score from baseline to 8-12 weeks. Scores range from 0 to 72, with higher scores indicating more severity.
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 4 Jun 2026.
- 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.
Jeffrey Cheng, MD, PhD principal investigator
University of California, San Francisco
Raymond Cho, MD, PhD principal investigator
University of California, San Francisco
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 in people with Atopic Dermatitis, run by University of California, San Francisco 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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 Jeffrey Cheng, MD, PhD (415 575 0524, rashes@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks (time frame: baseline and 8-12 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 4 Jun 2026.