- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012448
The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Nicole Nechiporchik
- Phone Number: 734-936-7519
- Email: nnechipo@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Nicole Nechiporchik
- Phone Number: 734-936-7519
- Email: nnechipo@umich.edu
-
Principal Investigator:
- Mio Nakamura, MD, MS
-
Sub-Investigator:
- Johann Gudjonsson, MD, PhD
-
Sub-Investigator:
- Allison Billi, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dupilumab
All patients will receive 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Week 0, week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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'.
|
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
|
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'.
|
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
|
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'.
|
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
|
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'.
|
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
|
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'.
|
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
|
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'.
|
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
|
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'.
|
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
|
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'.
|
Week 0, 24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mio Nakamura, MD, MS, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00227361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dermal Hypersensitivity Reaction
-
Université de SherbrookeTerminatedAnaphylaxis | Biphasic Anaphylactic Reaction | Rebound Anaphylactic ReactionCanada
-
AllerganCompletedDermal NoduleUnited States
-
Rajavithi HospitalChulalongkorn UniversityCompletedHypersensitivity ReactionThailand
-
Medical University of BialystokCompletedHypersensitivity Reaction
-
Hospices Civils de LyonCompletedAnaphylaxis | Allergic ReactionFrance
-
Centre Hospitalier Régional Metz-ThionvilleCompleted
-
University Hospital, GrenobleTerminatedAllergic Hypersensitivity Drug Reaction Versus Non-allergic Hypersensitivity Drug Reaction Cross ReactionFrance
-
Groupe Hospitalier Paris Saint JosephActive, not recruitingAllergic Reaction | Beta Lactam Adverse ReactionFrance
-
University Hospital, AntwerpNot yet recruitingHypersensitivity | Anaphylaxis | Allergic Reaction | Perioperative Complication | Immediate Hypersensitivity | Hypersensitivity, Drug | Anaphylactic ReactionBelgium
-
Clinica Universidad de Navarra, Universidad de...CompletedAnaphylactic ReactionSpain
Clinical Trials on Dupilumab
-
Brigham and Women's HospitalRegeneron PharmaceuticalsRecruiting
-
Akron Children's HospitalRegeneron Pharmaceuticals; Ohio State UniversityNot yet recruiting
-
University of MichiganRegeneron PharmaceuticalsRecruiting
-
Northwestern UniversityRecruitingSkin DiseasesUnited States
-
SanofiRegeneron PharmaceuticalsRecruitingChronic Rhinosinusitis With Nasal PolyposisFrance, Réunion
-
University of California, San FranciscoRecruiting
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAsthma; EosinophilicSpain
-
Montefiore Medical CenterRegeneron PharmaceuticalsRecruitingChronic Rhinosinusitis With Nasal PolypsUnited States
-
Johns Hopkins UniversityDoris Duke Charitable FoundationRecruiting