Active not recruiting

A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis (Eczema) Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable (BREEZE-AD4)

I4V-MC-JAIN - ClinicalTrials.gov - NCT03428100

The purpose of this study is to determine the efficacy and safety of baricitinib in combination with corticosteroids applied to the skin in participants with moderate to severe eczema. These participants did not have good results with cyclosporine or were not able to take it for medical reasons.
How long will I be in the trial?
Your participation could last up to 204 weeks and include up to 29 visits to the study center.
Email
Active not recruiting

A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis (Eczema) Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable (BREEZE-AD4)

I4V-MC-JAIN - ClinicalTrials.gov - NCT03428100

The purpose of this study is to determine the efficacy and safety of baricitinib in combination with corticosteroids applied to the skin in participants with moderate to severe eczema. These participants did not have good results with cyclosporine or were not able to take it for medical reasons.
How long will I be in the trial?
Your participation could last up to 204 weeks and include up to 29 visits to the study center.
Email

Key Requirements

Age :

18+

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

18+

Sex

All

Participants must

Participants must have been diagnosed with moderate to severe eczema for at least 12 months

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 had satisfactory results with existing medications applied to the skin

Participants must not be candidates for cyclosporine treatment because of one of the following: 1. They are not able to take it for medical reasons, 2. They are intolerant to it or developed toxicity from it, or 3. They had unsatisfactory results with it

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 or are currently taking antibiotics that affect the whole body or are applied to the skin

Participants must not have been treated with corticosteroids taken by mouth four weeks before treatment assignment or 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 and must agree to use 2 forms of birth control

Trial Summary

Conditions the trial is for

Atopic Dermatitis (Eczema)

What the trial is testing?

Baricitinib, Placebo, Topical corticosteroid

Could I receive a Placebo?

yes

Enrollment Goal

500

Trial Dates

May 2018 - June 2023

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

18+

Sex

All

Participants must

Participants must have been diagnosed with moderate to severe eczema for at least 12 months

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 had satisfactory results with existing medications applied to the skin

Participants must not be candidates for cyclosporine treatment because of one of the following: 1. They are not able to take it for medical reasons, 2. They are intolerant to it or developed toxicity from it, or 3. They had unsatisfactory results with it

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 or are currently taking antibiotics that affect the whole body or are applied to the skin

Participants must not have been treated with corticosteroids taken by mouth four weeks before treatment assignment or 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 and must agree to use 2 forms of birth control

Trial Summary

Conditions the trial is for

Atopic Dermatitis (Eczema)

What the trial is testing?

Baricitinib, Placebo, Topical corticosteroid

Could I receive a Placebo?

yes

Enrollment Goal

500

Trial Dates

May 2018 - June 2023

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?