Dupilumab De-escalation in Pediatric Atopic Dermatitis

Johns Hopkins University

Status and phase: Enrolling; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab - Dose Reduction; Drug: Dupilumab - Discontinuation; Drug: Dupilumab - Standard Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT06116526

IRB00405441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 3 patient groups

Dupilumab - discontinuation

Experimental group

Description:

Participants will discontinue their dupilumab treatment for atopic dermatitis.

Treatment:

Drug: Dupilumab - Discontinuation

Dupilumab - dose reduction

Experimental group

Description:

Participants whose standard dupilumab dosing for atopic dermatitis is 200 mg or 300 mg every 2 weeks will decrease drug administration to every 4 weeks, and participants whose standard dupilumab dosing is 200 mg or 300 mg every 4 weeks will decrease administration to every 8 weeks.

Treatment:

Drug: Dupilumab - Dose Reduction

Dupilumab - standard dosing

Experimental group

Description:

Participants will continue to receive standard maintenance dupilumab dosing for atopic dermatitis according to FDA labeling, as indicated below. Infants ≥6 months and Children \<6 years: 5 to \<15 kg: 200 mg every 4 weeks. 15 to \<30 kg: 300 mg every 4 weeks Children ≥6 years and Adolescents ≤17 years: 15 to \<30 kg: 300 mg every 4 weeks 30 to \<60 kg: 200 mg every other week ≥60 kg: 300 mg every other week

Treatment:

Drug: Dupilumab - Standard Dose