Dupilumab De-escalation in Pediatric Atopic Dermatitis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06116526
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniverisityBaltimoreMaryland21210
Zeena Mestari, BA
[email protected]
848-702-4101

Find similar trials in Baltimore, MD

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Johns Hopkins Univerisity· Baltimore, MD

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