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Monoclonal Antibodies

Dupilumab Dosing for Eczema

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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through week 16 (active protocol phase) and week 17 through week 52 (observational phase)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Successful Discontinuation of Dupilumab

Percentage of Participants with Successful Dose Reduction of Dupilumab

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out