A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis
Status: | Enrolling by invitation |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/5/2019 |
Start Date: | June 27, 2018 |
End Date: | September 18, 2021 |
A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult
participants with moderate to severe atopic dermatitis (AD), who have completed participation
in study BREEZE-AD5/Study JAIW (NCT03435081). This 116-week outpatient study, includes a
treatment period of approximately 104-weeks and up to 11 planned study visits.
participants with moderate to severe atopic dermatitis (AD), who have completed participation
in study BREEZE-AD5/Study JAIW (NCT03435081). This 116-week outpatient study, includes a
treatment period of approximately 104-weeks and up to 11 planned study visits.
Inclusion Criteria:
- Have been discontinued from study JAIW, and completed at least 16 weeks on treatment.
Exclusion Criteria:
- Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction
[MI], unstable angina, unstable arterial hypertension, severe heart failure, or
cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed
during a previous baricitinib study that, in the opinion of the investigator, pose an
unacceptable risk to the participant if investigational product continues to be
administered.
- Have a known hypersensitivity to baricitinib or any component of this investigational
product.
- Had investigational product permanently discontinued at any time during a previous
baricitinib study, except for participants who had investigational product
discontinued during originating study because of rescue with an oral systemic AD
therapy (e.g., corticosteroid, cyclosporine, methotrexate).
- Had temporary investigational product interruption continue at the final study visit
of a previous baricitinib study and, in the opinion of the investigator, this poses an
unacceptable risk for the participant's participation in the study.
- Pregnant or breastfeeding.
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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17271 Brookhurst Street
Fountain Valley, California 92708
Fountain Valley, California 92708
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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314 Martin Luther King Junior Way
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Tacoma, Washington 98405
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Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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