Recruiting

Dupilumab

Sponsor:

Johns Hopkins University

Code:

NCT06116526

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

Interventions

Dupilumab - Discontinuation

Dupilumab - Dose Reduction

Dupilumab - Standard Dose

Study Details

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.

Conditions

Atopic Dermatitis

Study ID

NCT06116526

Start date

Apr 1, 2024

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dupilumab - discontinuation

Participants will discontinue their dupilumab treatment for atopic dermatitis.

experimental: 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.

experimental: 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

Interventions

Dupilumab - Discontinuation

Drug injections are discontinued.

Dupilumab - Dose Reduction

The drug is given as a subcutaneous injection.

Dupilumab - Standard Dose

The drug is given as a subcutaneous injection.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Zeena Mestari, BA

‭+1 (848) 702-4101‬zmestar1@jh.edu

Rebecca Urbonas, BS

813-300-1317rurbona1@jh.edu

Locations

Johns Hopkins Univerisity

Recruiting

Baltimore, Maryland, United States, 21210

Contacts

Zeena Mestari, BA

848-702-4101Zmestar1@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.