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.
Email
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.
Email

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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Trial Locations

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Atopic Dermatitis (Eczema) Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?