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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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:
Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
Agree to use emollients daily.

Criterios de exclusión

Had investigational product permanently discontinued at any time during a previous Baricitinib study.
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
OR
Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following 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:
Monoclonal antibody for less than 5 half-lives prior to randomization.
Received prior treatment with any oral Janus kinase (JAK) inhibitor.
Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
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.

Ubicaciones

CEDIC-Centro de Investigaciones Clinicas

Caba, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, Argentina

Fundacion CIDEA

Ciudad Autonoma Buenos Aires, Argentina

Instituto de Neumonología y Dermatología

Ciudad Autonoma Buenos Aires, Argentina

Psoriahue Medicina Interdisciplinaria

Ciudad Autonoma Buenos Aires, Argentina

Parra Dermatología

Mendoza, Argentina

A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Baricitinib

Placebo

Ubicaciones

CEDIC-Centro de Investigaciones Clinicas

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires Skin

Fundacion CIDEA

Instituto de Neumonología y Dermatología

Psoriahue Medicina Interdisciplinaria

Parra Dermatología

Patrocinadores