NCT06116526 Dupilumab De-escalation in Pediatric Atopic Dermatitis
| NCT ID | NCT06116526 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Johns Hopkins University |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2024-04-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Joy Wan, MD MSCE
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06116526 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06116526 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06116526 currently recruiting?
Yes, NCT06116526 is actively recruiting participants. Contact the research team at zmestar1@jh.edu for enrollment information.
Where is the NCT06116526 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06116526 clinical trial?
NCT06116526 is sponsored by Johns Hopkins University. The principal investigator is Joy Wan, MD MSCE at Johns Hopkins University. The trial plans to enroll 30 participants.
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