Clinical trial NCT06116526: Dupilumab De-escalation in Pediatric Atopic Dermatitis
Official title: Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2023-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD) control on dupilumab.

Detailed description: Participants will be randomly assigned to one of three groups: discontinuation of dupilumab; reduction of dupilumab dose; or continuation of standard dupilumab dose. During the active study treatment period, participants will be asked to complete 5 study visits. At these visits, a physician will conduct a skin examination to assess atopic dermatitis (AD) severity and participants will complete questionnaires about their AD symptoms and severity. During the observational period, participants will be asked to complete questionnaires about their AD symptoms and medication use every twelve weeks, for a total of 3 follow-up contacts. The purpose of this study is to evaluate the feasibility and sustainability of reducing or discontinuing dupilumab in children with well-controlled AD.

Eligibility criteria: Inclusion Criteria:

* Aged 1 to \<18 years old, either sex, any race or ethnicity
* Provide signed informed consent by parent or legal guardian and informed assent if applicable
* Has a physician confirmed diagnosis of atopic dermatitis
* Has received dupilumab for at least 12 months for the treatment of atopic dermatitis
* Has had well-controlled atopic dermatitis on dupilumab within last 6 months (defined as POEM\<=7, EASI\<=7, or IGA\<=2)
* Able to speak English
* Able and willing to adhere to all study procedures

Exclusion Criteria:

* Taking concurrent systemic medication for atopic dermatitis (e.g., methotrexate, cyclosporine, tralokinumab, abrocitinib, upadacitinib, systemic corticosteroids)
* Using concurrent phototherapy for atopic dermatitis
* Taking dupilumab for a clinical indication other than atopic dermatitis (such as asthma or eosinophilic esophagitis)
* Poor control of atopic dermatitis
* Poor control of asthma or eosinophilic esophagitis
* Has used an investigational drug within 90 days or plan to use an investigational drug during the study period
* Does not have health insurance or will lose health insurance during the study period

Primary outcomes:
measure: Percentage of Participants with Successful Dose Reduction of Dupilumab
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Percentage of Participants with Successful Discontinuation of Dupilumab
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
Secondary outcomes:
measure: Change in Investigator's Global Assessment (IGA) Scores
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Eczema Area and Severity Index (EASI) Scores
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Patient Oriented Eczema Measure (POEM) Scores
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Children's Dermatology Life Quality Index (CDLQI) score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Change in Family Dermatology Life Quality Index (FDLQI) score
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Changes in Utilization of Topical Medications for Atopic Dermatitis
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
measure: Adverse Events After Dupilumab Dose-reduction or Discontinuation
timeFrame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Univerisity
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joy Wan, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drucker AM, Wang AR, Li WQ, Sevetson E, Block JK, Qureshi AA. The Burden of Atopic Dermatitis: Summary of a Report for the National Eczema Association. J Invest Dermatol. 2017 Jan;137(1):26-30. doi: 10.1016/j.jid.2016.07.012. Epub 2016 Sep 8.
citation: Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1.