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Monoclonal Antibodies

Dupilumab - standard dosing for Atopic Dermatitis

Phase 4
Recruiting
Led By Joy Wan, MD MSCE
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through week 16 (active protocol phase) and week 17 through week 52 (observational phase)
Awards & highlights

Study Summary

This trial will test if children aged 1-17 years with atopic dermatitis can stop or reduce their dupilumab treatment, which has been controlling their condition effectively.

Who is the study for?
This trial is for children aged 1-17 with well-controlled atopic dermatitis (eczema) who have been on dupilumab for at least a year. They must understand English and follow study procedures. A parent or guardian's consent (and child's assent if applicable) is required.Check my eligibility
What is being tested?
The study tests whether it's feasible to stop giving dupilumab or reduce its dose in kids who've had their eczema under control with the standard dose of this medication. It’s a pilot trial where participants are randomly assigned to continue, stop, or reduce the drug.See study design
What are the potential side effects?
Dupilumab may cause side effects like injection site reactions, eye problems, cold sores in your mouth or on your lips, and inflammation of your blood vessels. Rarely, it might lead to more serious issues like allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through week 16 (active protocol phase) and week 17 through week 52 (observational phase)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through week 16 (active protocol phase) and week 17 through week 52 (observational phase) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Successful Discontinuation of Dupilumab
Percentage of Participants with Successful Dose Reduction of Dupilumab
Secondary outcome measures
Adverse Events After Dupilumab Dose-reduction or Discontinuation
Change in Children's Dermatology Life Quality Index (CDLQI) score
Change in Eczema Area and Severity Index (EASI) Scores
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dupilumab - standard dosingExperimental Treatment1 Intervention
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 II: Dupilumab - dose reductionExperimental Treatment1 Intervention
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 III: Dupilumab - discontinuationExperimental Treatment1 Intervention
Participants will discontinue their dupilumab treatment for atopic dermatitis.

Find a Location

Who is running the clinical trial?

Doris Duke Charitable FoundationOTHER
61 Previous Clinical Trials
260,056 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,267 Previous Clinical Trials
14,837,532 Total Patients Enrolled
Joy Wan, MD MSCEPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
400 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall patient enrollment count for this particular research investigation?

"Indeed, the details from clinicaltrials.gov indicate an ongoing search for participants in this research endeavor. This investigation was initially shared on April 1st, 2024 and received its most recent update on April 9th, 2024. The objective is to enlist a total of 30 volunteers from one designated location."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary aim of this research is to assess the success rate of discontinuing Dupilumab, evaluated from baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase). Secondary goals include evaluating changes in Eczema Area and Severity Index (EASI) scores. The EASI score measures atopic dermatitis severity based on clinical signs across body regions using a scale ranging from absent to severe. Furthermore, assessing alterations in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire scores aims to gauge the extent of depressive symptoms experienced by patients over a week"

Answered by AI

Are there still opportunities for individuals to participate in this ongoing clinical trial?

"Indeed, the details on clinicaltrials.gov imply that this particular medical study is actively pursuing eligible participants. Initially shared on April 1st, 2024, and most recently revised on April 9th, 2024, the trial aims to enroll a total of 30 patients at a single designated site."

Answered by AI

Am I eligible to be a part of this medical study?

"This research is seeking 30 participants aged between 1 year and 17 years with atopic dermatitis. Eligible individuals must meet the subsequent criteria: Age range from 1 to under 18, any gender identity, belonging to any racial or ethnic group, Submission of signed consent by a parent or legal guardian along with informed assent if necessary, Confirmation of atopic dermatitis diagnosis by a healthcare provider, Administration of dupilumab for no less than one year for managing atopic dermatitis symptoms, Demonstrated well-controlled atopic dermatitis while on dupilumab in the past six months (as defined by POEM"

Answered by AI

What is the level of safety associated with reducing the dosage of Dupilumab for individuals?

"Our team at Power ranks the safety of Dupilumab - dose reduction as 3 out of 3, given that this Phase 4 trial signifies approval for treatment."

Answered by AI

Are individuals above the age of 40 being sought for enrollment in this study?

"Applicants deemed eligible for this study must fall within the age range of 1 year to 17 years. Notably, there are 93 ongoing clinical trials catering to individuals under 18 and 176 aimed at those above 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dupilumab De-escalation in Pediatric Atopic Dermatitis
2024. "Dupilumab De-escalation in Pediatric Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06116526.
All > Atopic Dermatitis
~20 spots leftby Apr 2026
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