Dupilumab De-escalation in Pediatric Atopic Dermatitis

NCT06116526 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00405441
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Successful Dose Reduction of Dupilumab

  Successful de-escalation is defined as maintaining a reduced dose (i.e., less frequent administration) of dupilumab after initial de-escalation on week 0. Patients who require re-escalating the dose of dupilumab to standard dosing or adding other systemic treatments for their AD will be regarded as treatment failure.

  From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

• Percentage of Participants with Successful Discontinuation of Dupilumab

  Successful discontinuation is defined as maintaining discontinuation of dupilumab after initial discontinuation on week 0. Patients who require resumption of dupilumab or beginning other systemic treatments for their AD will be regarded as treatment failure.

  From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

Secondary Outcomes (14)

• Change in Investigator's Global Assessment (IGA) Scores

  From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

• Change in Eczema Area and Severity Index (EASI) Scores

  From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

• Change in Patient Oriented Eczema Measure (POEM) Scores

  From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score

  From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score

  From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

Study Arms (3)

Dupilumab - discontinuation

EXPERIMENTAL

Participants will discontinue their dupilumab treatment for atopic dermatitis.

Drug: Dupilumab - Discontinuation

Dupilumab - dose reduction

EXPERIMENTAL

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.

Drug: Dupilumab - Dose Reduction

Dupilumab - standard dosing

EXPERIMENTAL

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

Drug: Dupilumab - Standard Dose

Interventions

Dupilumab - Discontinuation DRUG

Drug injections are discontinued.

Also known as: Dupixent

Dupilumab - discontinuation

Dupilumab - Dose Reduction DRUG

The drug is given as a subcutaneous injection.

Also known as: Dupixent

Dupilumab - dose reduction

Dupilumab - Standard Dose DRUG

The drug is given as a subcutaneous injection.

Also known as: Dupixent

Dupilumab - standard dosing

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Johns Hopkins Univerisity

Baltimore, Maryland, 21210, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 27616422 BACKGROUND

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

  PMID: 32738956 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Joy Wan, MD MSCE

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeena Mestari, BA

CONTACT

‭+1 (848) 702-4101‬; zmestar1@jh.edu

Rebecca Urbonas, BS

CONTACT

813-300-1317; rurbona1@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are unblinded to the trial arm. Clinical outcomes will be assessed by a blinded investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)