Dupilumab De-escalation in Pediatric Atopic Dermatitis

NCT ID: NCT06116526

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-04-30

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dupilumab - discontinuation

Participants will discontinue their dupilumab treatment for atopic dermatitis.

Group Type: EXPERIMENTAL

Dupilumab - Discontinuation

Intervention Type: DRUG

Drug injections are discontinued.

Dupilumab - dose reduction

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.

Group Type: EXPERIMENTAL

Dupilumab - Dose Reduction

Intervention Type: DRUG

The drug is given as a subcutaneous injection.

Dupilumab - standard dosing

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

Group Type: EXPERIMENTAL

Dupilumab - Standard Dose

Intervention Type: DRUG

The drug is given as a subcutaneous injection.

Interventions

Dupilumab - Discontinuation

Drug injections are discontinued.

Intervention Type: DRUG

Dupilumab - Dose Reduction

The drug is given as a subcutaneous injection.

Intervention Type: DRUG

Dupilumab - Standard Dose

The drug is given as a subcutaneous injection.

Intervention Type: DRUG

Other Intervention Names

Dupixent; Dupixent; Dupixent

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joy Wan, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Univerisity

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zeena Mestari, BA

Role: CONTACT

zmestar1@jh.edu

‭+1 (848) 702-4101‬

Rebecca Urbonas, BS

Role: CONTACT

rurbona1@jh.edu

813-300-1317

Facility Contacts

Zeena Mestari, BA

Role: primary

Zmestar1@jh.edu

848-702-4101

References

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.

Reference Type: BACKGROUND

PMID: 27616422 (View on PubMed)

Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1.

Reference Type: BACKGROUND

PMID: 32738956 (View on PubMed)

Other Identifiers

IRB00405441

Identifier Type: -

Identifier Source: org_study_id