Clinical trial NCT06012448: The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction
Official title: The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermal Hypersensitivity Reaction
Keywords: Skin rash
Dupilumab
Skin biopsies
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2023-08-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change in Th2 immune cell population in lesional Dermal hypersensitivity reaction (DHR) skin at week 16 compared to week 0.
timeFrame: Week 0, week 16
Secondary outcomes:
measure: Changes in Total Body surface area (TBSA) in patients with DHR treated with dupilumab at week 2 from week 0.
timeFrame: Week 0, week 2
measure: Changes in Total Body surface area in patients with DHR treated with dupilumab at week 8 from week 0.
timeFrame: Week 0, week 8
measure: Changes in Total Body surface area in patients with DHR treated with dupilumab at week 16 from week 0.
timeFrame: Week 0, week 16
measure: Changes in Total Body surface area in patients with DHR treated with dupilumab at week 24 from week 0.
timeFrame: Week 0, week 24
measure: Changes in Investigator Global Assessment (IGA) in patients with DHR treated with dupilumab at week 2 from week 0.
timeFrame: Week 0, 2 weeks
measure: Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 8 from week 0.
timeFrame: Week 0, 8 weeks
measure: Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 16 from week 0.
timeFrame: Week 0, 16 weeks
measure: Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 24 from week 0.
timeFrame: Week 0, 24weeks
measure: Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 2 from week 0.
timeFrame: Week 0, 2 weeks
measure: Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 8 from week 0.
timeFrame: Week 0, 8 weeks
measure: Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 16 from week 0.
timeFrame: Week 0, 16 weeks
measure: Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 24 from week 0.
timeFrame: Week 0, 24 weeks
measure: Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 2 from week 0.
timeFrame: Week 0, 2 weeks
measure: Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 8 from week 0.
timeFrame: Week 0, 8 weeks
measure: Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 16 from week 0.
timeFrame: Week 0, 16 weeks
measure: Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 24 from week 0.
timeFrame: Week 0, 24 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mio Nakamura, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: