Estudio de fase 3, multicéntrico, aleatorizado, doble cie... | EligiMed

Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de baricitinib en combinación con corticosteroides tópicos en pacientes adultos con dermatitis atópica moderada a grave. BREEZE-AD7.

CompletadoFase 3ClinicalTrials.gov

ID: NCT03733301Tipo: INTERVENTIONALInicio: 16 de nov de 2018Fin estimado: 22 de ago de 2019

Resumen

El propósito de este estudio es evaluar la eficacia y seguridad de baricitinib en combinación con corticosteroides tópicos (CT) en participantes con dermatitis atópica moderada a grave.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months.
Have had inadequate response 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

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 episodes 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 less than 4 weeks prior to randomization.
Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection 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 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.

Intervenciones

drug

Baricitinib

Administered orally.

drug

Topical corticosteroid

Administered as standard-of-care.

drug

Placebo

Administered orally.

Ubicaciones

Centro de Investigaciones Metabólicas (CINME) - Comite

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

Patrocinadores

PrincipalEli Lilly and Company

ColaboradorIncyte Corporation

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