Recruiting
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
I4V-MC-JAIP - ClinicalTrials.gov - NCT03952559
The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.
How long will I be in the trial?
The study will last about 224 weeks and may include up to 28 visits.
Recruiting
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
I4V-MC-JAIP - ClinicalTrials.gov - NCT03952559
The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.
How long will I be in the trial?
The study will last about 224 weeks and may include up to 28 visits.
Key Requirements
Age :
2-17
Sex:
All
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
2-17
Sex
All
Participants must
Participants must have been diagnosed with moderate to severe atopic dermatitis (eczema) for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old)
Participants must not have had satisfactory results with existing medications applied to the skin within 6 months before screening
Participants must be willing to stop taking certain eczema treatments
Participants must agree to use a lotion or cream that softens the skin daily
Participants must NOT
Participants must not have other skin conditions (such as psoriasis or lupus) or a history of skin diseases or infections that did not respond to treatment or require frequent hospitalization and/or IV treatment
Participants must not have a skin infection that requires antibiotics
Participants must not have been treated with corticosteroids given by injection within 6 weeks prior to treatment assignment and are not expected to need corticosteroid injections during the study
Participants must not have uncontrolled high blood pressure, major surgery (within the last two months or planned to take place during the study), or recent blood clot, heart attack, chest pain, stroke, heart failure or any other serious or unstable disease or infection
Female participants must not be pregnant or breastfeeding
Trial Summary
Conditions the trial is for
Atopic Dermatitis (Eczema)
What the trial is testing?
Baricitinib, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
465
Trial Dates
May 2019 - April 2026
Trial Phase
3
Enter your postal code to find the nearest site
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
2-17
Sex
All
Participants must
Participants must have been diagnosed with moderate to severe atopic dermatitis (eczema) for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old)
Participants must not have had satisfactory results with existing medications applied to the skin within 6 months before screening
Participants must be willing to stop taking certain eczema treatments
Participants must agree to use a lotion or cream that softens the skin daily
Participants must NOT
Participants must not have other skin conditions (such as psoriasis or lupus) or a history of skin diseases or infections that did not respond to treatment or require frequent hospitalization and/or IV treatment
Participants must not have a skin infection that requires antibiotics
Participants must not have been treated with corticosteroids given by injection within 6 weeks prior to treatment assignment and are not expected to need corticosteroid injections during the study
Participants must not have uncontrolled high blood pressure, major surgery (within the last two months or planned to take place during the study), or recent blood clot, heart attack, chest pain, stroke, heart failure or any other serious or unstable disease or infection
Female participants must not be pregnant or breastfeeding
Trial Summary
Conditions the trial is for
Atopic Dermatitis (Eczema)
What the trial is testing?
Baricitinib, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
465
Trial Dates
May 2019 - April 2026
Trial Phase
3
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