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Monoclonal Antibodies
Tralokinumab + Topical Corticosteroids for Eczema (TRAPEDS 2 Trial)
Phase 3
Recruiting
Research Sponsored by LEO Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented inadequate response to mid-strength TCS within 6 months before the screening visit.
Body weight ≥9 kg at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 16 to 52
Awards & highlights
Pivotal Trial
Summary
This trial aims to test the safety and effectiveness of using tralokinumab injections along with topical corticosteroids to treat moderate-to-severe atopic dermatitis in children and infants. The
Who is the study for?
This trial is for children and infants aged 6 months to under 12 years with moderate-to-severe atopic dermatitis (eczema) who haven't improved with mid-strength topical corticosteroids. They must weigh at least 9 kg, have had AD for a minimum of 3-12 months depending on age, and show significant itchiness or scratching.
What is being tested?
The trial tests if tralokinumab injections plus topical corticosteroids are more effective than placebo plus TCS in treating eczema. Children will be randomly assigned to treatments for the first 16 weeks; then all get tralokinumab + TCS. Infants receive only the actual drug from the start.
What are the potential side effects?
Tralokinumab may cause injection site reactions, eye inflammation, allergic reactions, and infections. Topical corticosteroids can thin the skin, cause discoloration, or lead to hormone level changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin condition didn't improve after using a prescribed cream in the last 6 months.
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My body weight is at least 9 kg.
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I am between 6 months and 12 years old.
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I have been diagnosed with atopic dermatitis according to specific criteria.
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My skin condition affects more than 10% of my body.
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I have had atopic dermatitis for the required time based on my age.
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My itch score is 4 or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 16 to 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 16 to 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening.
Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening.
Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening.
+34 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Tralokinumab + TCS for subjects aged 6 months to <2 yearsExperimental Treatment1 Intervention
Dose and dosing frequency for each subject will depend on the subject's body weight.
Group II: Tralokinumab + TCS for subjects aged 2 to <12 yearsExperimental Treatment1 Intervention
Dose and dosing frequency for each subject will depend on the subject's body weight.
Group III: Placebo + TCS for subjects aged 2 to <12 yearsExperimental Treatment1 Intervention
Dose and dosing frequency for each subject will depend on the subject's body weight.
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Who is running the clinical trial?
LEO PharmaLead Sponsor
271 Previous Clinical Trials
188,678 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
10,117 Total Patients Enrolled