A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.
Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.
Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions:
Exclusion Criteria:
OR
Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:
Inclusion Criteria:
Exclusion Criteria:
Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
Have been treated with the following therapies:
Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
Have had major surgery within the past eight weeks or are planning major surgery during the study.
Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
Have specific laboratory abnormalities.
Have received certain treatments that are contraindicated.
Pregnant or breastfeeding.
Caba, Buenos Aires C1425DES, Argentina
Ciudad Autonoma Buenos Aires, C1055AA0, Argentina
Ciudad Autonoma Buenos Aires, C1121ABE, Argentina
Ciudad Autonoma Buenos Aires, C1425BEA, Argentina
Ciudad Autonoma Buenos Aires, C1425DKG, Argentina
Plzen-Bory, Plzeň Region 305 99, Czechia
Ústí nad Labem, Ustecký Kraj 40113, Czechia
Grenoble Cédex 9, 38043, France
Aachen, 52074, Germany
New Delhi, National Capital Territory of Delhi 110 029, India
Ichikawa-shi, Chiba 272-0033, Japan
Matsudo-shi, Chiba 271-0092, Japan
Inashiki-gun, Ibaraki 300-0395, Japan
Kashima-machi, Kamimashiki-gun, Kumamoto 861-3101, Japan
Nishi-ku Sakai-shi, Osaka 593-8324, Japan
Toyonaka-shi, Osaka 560-0085, Japan
Ohmiya-ku,Saitama-shi, Saitama 330-0854, Japan
Chiyoda-ku, Tokyo 102-0072, Japan
Chiyoda-Ku, Tokyo 102-8798, Japan
Chuo-ku, Tokyo 103-0025, Japan
Chuo-ku, Tokyo 104-0031, Japan
Edogawa-ku, Tokyo 133-0057, Japan
Nerima-ku, Tokyo 178-0063, Japan
Setagaya-ku, Tokyo 158-0097, Japan
Shinagawa-KU, Tokyo 141-8625, Japan
Tachikawa-shi, Tokyo 190-0023, Japan
Takaoka-shi, Toyama 9330871, Japan
Morelia, Michoacan Morelia CP 58249, Mexico
Bialystok, Podlaskie Voivodeship 15-375, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-229, Poland