Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
Johns Hopkins Univerisity
RECRUITING
Baltimore
Contact Information
Primary
Rebecca Urbonas, BS
rurbona1@jh.edu
813-300-1317
Backup
Sumrah Jilani, BS
sjilani3@jhmi.edu
989-395-6412
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Doris Duke Charitable Foundation
Leads: Johns Hopkins University