Reducing or stopping dupilumab treatment in children with controlled atopic dermatitis
Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
This study is testing whether children aged 1-17 with controlled atopic dermatitis can safely stop or lower their dupilumab treatment to see how it affects their skin condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | dupilumab, tralokinumab, abrocitinib, upadacitinib, methotrexate |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06116526 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the feasibility of discontinuing or reducing the dose of dupilumab in children aged 1-17 years who have maintained control of atopic dermatitis (AD) while on the medication. Participants will be randomly assigned to one of three groups: stopping dupilumab, reducing the dose, or continuing the standard dose. The study involves five visits for skin examinations and questionnaires to assess AD severity and symptoms. Additionally, there will be follow-up contacts every twelve weeks to monitor symptoms and medication use during the observational period.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 17 years who have well-controlled atopic dermatitis on dupilumab for at least 12 months.
Not a fit: Patients currently taking other systemic medications for atopic dermatitis or those with poorly controlled atopic dermatitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine safe strategies for reducing or stopping dupilumab treatment in children, potentially minimizing medication exposure and side effects.
How similar studies have performed: While this approach is novel in the context of dupilumab, similar studies evaluating treatment de-escalation in chronic conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Univerisity — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Joy Wan, MD MSCE — Johns Hopkins University
- Study coordinator: Zeena Mestari, BA
- Email: zmestar1@jh.edu
- Phone: +1 (848) 702-4101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.