Dupilumab De-escalation in Pediatric Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dupilumab - Discontinuation, Dupilumab - Dose Reduction, Dupilumab - Standard Dose.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 1 year — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
Overview
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.
Interventions
- Drug Dupilumab - Discontinuation
Drug injections are discontinued. - Drug Dupilumab - Dose Reduction
The drug is given as a subcutaneous injection. - Drug Dupilumab - Standard Dose
The drug is given as a subcutaneous injection.
Primary outcome measures
- Percentage of Participants with Successful Dose Reduction of Dupilumab [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Percentage of Participants with Successful Discontinuation of Dupilumab [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
Secondary outcome measures (12)
- Change in Investigator's Global Assessment (IGA) Scores [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Eczema Area and Severity Index (EASI) Scores [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient Oriented Eczema Measure (POEM) Scores [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Children's Dermatology Life Quality Index (CDLQI) score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Family Dermatology Life Quality Index (FDLQI) score [Time frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins Univerisity — Baltimore
Publications
- 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. PMID 27616422
- Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1. PMID 32738956
Identifiers
NCT: NCT06116526 · IRB00405441