Dermal Hypersensitivity ReactionPhase 4NCT06012448
The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction
A Phase 4 study testing Dupilumab in people with Dermal Hypersensitivity Reaction, run by University of Michigan at 1 site in United States.
Trial summary
This research is studying a drug called dupilumab to learn about its safety and its effect as a treatment for participants with dermal hypersensitivity reaction. This study will help better understand why and how dermal hypersensitivity reaction occurs and how dupilumab might help treat this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermal Hypersensitivity Reaction
- 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 25 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of chronic idiopathic DHR as defined by presence of clinical and histopathologic features of DHR for at least 6 weeks without an underlying cause or associated trigger
- Moderate-to-severe DHR as defined by greater or equal 5% total body-surface-area (TBSA) involvement and IGA of greater or equal to 3.
- Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
- Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.
Who cannot join
- Subjects meeting 1 or more of the following criteria at screening or baseline:
- Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
- Reporting asthma that has not been well-controlled (ie, symptoms occurring on >2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months.
- Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
- Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
- Confirmed or suspected COVID-19 infection within 4 weeks before the screening or baseline visit.
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- Previous treatment with dupilumab.
- Pregnant women (positive urine pregnancy test result at the screening visit or the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study.
- History of, current, or suspected lymphoproliferative disease or malignancy of any organ system within the last 5 years, except for basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the baseline visit.
- History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, i.e., monoclonal antibody) or to lidocaine.
- Known active or latent tuberculosis (TB) infection.
- Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
- History of or current confounding skin condition (i.e., active atopic dermatitis, chronic urticaria, psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).
- Planned or expected major surgical procedure during the clinical study.
- Currently participating or participated in any other study of a drug or device, within the past 8 weeks before the screening visit, or is in an exclusion period (if verifiable) from a previous study.
- History of alcohol or substance abuse within 6 months of the screening.
- History of poor wound healing or keloid formation.
Trial locations and contacts
1 site in 1 country.
About this study
This research is studying a drug called dupilumab to learn about its safety and its effect as a treatment for participants with dermal hypersensitivity reaction. This study will help better understand why and how dermal hypersensitivity reaction occurs and how dupilumab might help treat this condition.
Read the detailed description
Dermal hypersensitivity reaction is a skin rash that can happen as a reaction to a known trigger or it can happen for unknown reasons. Not a lot is known about why the rash occurs and what happens to the immune system to cause this rash. Dupilumab, a biologic drug that is given as an injection under the skin, may treat dermal hypersensitivity reaction. This study tries to better understand dermal hypersensitivity reaction and how the immune system responds to dupilumab.
- Conditions
- Dermal Hypersensitivity Reaction
- Being tested
- Dupilumab
- Keywords
- Skin rash, Dupilumab, Skin biopsies
- Medical subject headings
- Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
Patients will start by getting dupilumab 600 milligram (mg) subcutaneously at week 0, followed by 300 mg every 2 weeks starting at week 2. The last dose will be given at week 24.
In addition, participants will have visits at the research site for examinations, provide health information, laboratory draws, skin biopsies (at certain time points). Participation in the study will last approximately 28 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | All patients will receive dupilumab. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Th2 immune cell population in lesional Dermal hypersensitivity reaction (DHR) skin at week 16 compared to week 0.
Measured: Week 0, week 16
Secondary outcomes (16)
Changes in Total Body surface area (TBSA) in patients with DHR treated with dupilumab at week 2 from week 0.
The TBSA involvement of DHR will be assessed by the investigator or trained designee for each part of the body (the possible highest score for each region is head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined.
Measured: Week 0, week 2
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 8 from week 0.
The TBSA involvement of DHR will be assessed by the investigator or trained designee for each part of the body (the possible highest score for each region is head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined.
Measured: Week 0, week 8
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 16 from week 0.
The TBSA involvement of DHR will be assessed by the investigator or trained designee for each part of the body (the possible highest score for each region is head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined.
Measured: Week 0, week 16
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 24 from week 0.
The TBSA involvement of DHR will be assessed by the investigator or trained designee for each part of the body (the possible highest score for each region is head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined.
Measured: Week 0, week 24
Changes in Investigator Global Assessment (IGA) in patients with DHR treated with dupilumab at week 2 from week 0.
The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of Dermal Hypersensitivity Reaction and the clinical response to a treatment. Treatment success is defined as 0 (clear) or 1 (almost clear) and a 2-point improvement from baseline.
Measured: Week 0, 2 weeks
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 8 from week 0.
The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of Dermal Hypersensitivity Reaction and the clinical response to a treatment. Treatment success is defined as 0 (clear) or 1 (almost clear) and a 2-point improvement from baseline.
Measured: Week 0, 8 weeks
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 16 from week 0.
The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of Dermal Hypersensitivity Reaction and the clinical response to a treatment. Treatment success is defined as 0 (clear) or 1 (almost clear) and a 2-point improvement from baseline.
Measured: Week 0, 16 weeks
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 24 from week 0.
The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of Dermal Hypersensitivity Reaction and the clinical response to a treatment. Treatment success is defined as 0 (clear) or 1 (almost clear) and a 2-point improvement from baseline.
Measured: Week 0, 24weeks
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 2 from week 0.
This scale is used to report the intensity of pruritus during the last 24 hours. The Average Pruritus NRS (AP NRS) provides a measure of overall pruritus intensity over a given period and has clinical relevance to both subjects and physicians because peak pruritus may show higher intensity but short duration. Participants will select from a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Week 0, 2 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 8 from week 0.
This scale is used to report the intensity of pruritus during the last 24 hours. The Average Pruritus NRS (AP NRS) provides a measure of overall pruritus intensity over a given period and has clinical relevance to both subjects and physicians because peak pruritus may show higher intensity but short duration. Participants will select from a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Week 0, 8 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 16 from week 0.
This scale is used to report the intensity of pruritus during the last 24 hours. The Average Pruritus NRS (AP NRS) provides a measure of overall pruritus intensity over a given period and has clinical relevance to both subjects and physicians because peak pruritus may show higher intensity but short duration. Participants will select from a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Week 0, 16 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 24 from week 0.
This scale is used to report the intensity of pruritus during the last 24 hours. The Average Pruritus NRS (AP NRS) provides a measure of overall pruritus intensity over a given period and has clinical relevance to both subjects and physicians because peak pruritus may show higher intensity but short duration. Participants will select from a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Week 0, 24 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 2 from week 0.
This scale is used to report the intensity of pruritus during the last 24 hours. The maximum itch intensity will be noted by the participants by indicating on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Week 0, 2 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 8 from week 0.
This scale is used to report the intensity of pruritus during the last 24 hours. The maximum itch intensity will be noted by the participants by indicating on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Week 0, 8 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 16 from week 0.
This scale is used to report the intensity of pruritus during the last 24 hours. The maximum itch intensity will be noted by the participants by indicating on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Week 0, 16 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 24 from week 0.
This scale is used to report the intensity of pruritus during the last 24 hours. The maximum itch intensity will be noted by the participants by indicating on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Measured: Week 0, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start2 Oct 2023
- Primary completion7 Jan 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermal Hypersensitivity ReactionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Mio Nakamura, University of Michigan
- Investigators
- Mio Nakamura, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012448
- Sponsor's protocol ID
- HUM00227361
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2023
- Last updated
- 12 Jan 2026
- Results posted
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction
- ClinicalTrials.gov ID
- NCT06012448
- Acronym / sponsor ID
- HUM00227361
- Conditions
- Dermal Hypersensitivity Reaction
- Keywords
- Skin rash, Dupilumab, Skin biopsies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 25 Aug 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 research is studying a drug called dupilumab to learn about its safety and its effect as a treatment for participants with dermal hypersensitivity reaction. This study will help better understand why and how dermal hypersensitivity reaction occurs and how dupilumab might help treat this condition.
Detailed description
Dermal hypersensitivity reaction is a skin rash that can happen as a reaction to a known trigger or it can happen for unknown reasons. Not a lot is known about why the rash occurs and what happens to the immune system to cause this rash. Dupilumab, a biologic drug that is given as an injection under the skin, may treat dermal hypersensitivity reaction. This study tries to better understand dermal hypersensitivity reaction and how the immune system responds to dupilumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabAll patients will receive dupilumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established diagnosis of chronic idiopathic DHR as defined by presence of clinical and histopathologic features of DHR for at least 6 weeks without an underlying cause or associated trigger
- Moderate-to-severe DHR as defined by greater or equal 5% total body-surface-area (TBSA) involvement and IGA of greater or equal to 3.
- Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
- Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.
Key exclusion criteria (17 listed)
- Subjects meeting 1 or more of the following criteria at screening or baseline:
- Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
- Reporting asthma that has not been well-controlled (ie, symptoms occurring on >2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months.
- Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
- Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
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: DupixentPatients will start by getting dupilumab 600 milligram (mg) subcutaneously at week 0, followed by 300 mg every 2 weeks starting at week 2. The last dose will be given at week 24. In addition, participants will have visits at the research site for examinations, provide health information, laboratory draws, skin biopsies (at certain time points). Participation in the study will last approximately 28 weeks. | Drug | Dupilumab |
Primary outcome
Change in Th2 immune cell population in lesional Dermal hypersensitivity reaction (DHR) skin at week 16 compared to week 0.
Time frame: Week 0, week 16
16 secondary outcomes
Changes in Total Body surface area (TBSA) in patients with DHR treated with dupilumab at week 2 from week 0.
Time frame: Week 0, week 2
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 8 from week 0.
Time frame: Week 0, week 8
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 16 from week 0.
Time frame: Week 0, week 16
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 24 from week 0.
Time frame: Week 0, week 24
Changes in Investigator Global Assessment (IGA) in patients with DHR treated with dupilumab at week 2 from week 0.
Time frame: Week 0, 2 weeks
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 8 from week 0.
Time frame: Week 0, 8 weeks
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 16 from week 0.
Time frame: Week 0, 16 weeks
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 24 from week 0.
Time frame: Week 0, 24weeks
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 2 from week 0.
Time frame: Week 0, 2 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 8 from week 0.
Time frame: Week 0, 8 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 16 from week 0.
Time frame: Week 0, 16 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 24 from week 0.
Time frame: Week 0, 24 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 2 from week 0.
Time frame: Week 0, 2 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 8 from week 0.
Time frame: Week 0, 8 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 16 from week 0.
Time frame: Week 0, 16 weeks
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 24 from week 0.
Time frame: Week 0, 24 weeks
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 12 Jan 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. This study is not recruiting at the moment.
Mio Nakamura, MD, MS principal investigator
University of Michigan
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 Dermal Hypersensitivity Reaction, run by University of Michigan 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 4 inclusion and 17 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 12 Jan 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?
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?
Change in Th2 immune cell population in lesional Dermal hypersensitivity reaction (DHR) skin at week 16 compared to week 0. (time frame: Week 0, week 16). 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 Jan 2026.