The Immunologic Effects of Dupilumab in the Treatment of... | NCT06012448

NCT06012448

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Description Module

Label	Type	Description	Intervention Names
Dupilumab	Experimental	All patients will receive dupilumab.	Drug: Dupilumab

Name	Type	Description	Arm Group Labels	Other Names
Dupilumab	Drug	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.

Outcomes Module

Measure	Description	Time Frame
Change in Th2 immune cell population in lesional Dermal hypersensitivity reaction (DHR) skin at week 16 compared to week 0.		Week 0, week 16

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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.

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases