Study Condition(s): Atopic Dermatitis

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)

Study Alias: JAIN

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT03428100 {{ currentLocaleObject.registryAnchorText }}

Withdrawn Not yet recruiting

Study Purpose

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.

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18+ years

Time Commitment

Your participation could last up to 108 weeks and include up to 23 visits to the study center.
  • Participants must have been diagnosed with moderate to severe eczema for at least 12 months

  • Participants must not have had satisfactory results with existing medications applied to the skin

  • 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 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

Where to Participate

102 locations are currently available of 119 planned
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