A Phase 4 interventional study of Dupilumab in Dermal Hypersensitivity Reaction, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by University of Michigan · Phase 4, Interventional, and Treatment
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.
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.
68 studies on the registry are indexed under Exanthema; 11 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 45 interventional studies indexed under Exanthema.
Browse Exanthema studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will receive dupilumab.
Drug: Dupilumab
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.
Also known as: Dupixent
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: Week 0, 24 weeks
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dupilumab