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Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Severe Atopic Dermatitis (Liberty AD PRESCHOOL)

Overview

Información sobre este estudio

This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in patients 6 months to less than 6 years of age with severe atopic dermatitis (AD).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  1. Diagnosis of AD according to the American Academy of Dermatology consensus criteria at the screening visit
  2. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s)
  3. IGA = 4 at screening and baseline visits
  4. EASI ≥21 at screening and baseline visits
  5. Body Surface Area (BSA) ≥15% at screening and baseline visits

Exclusion Criteria

  1. Participation in a prior dupilumab clinical study
  2. History of important side effects of medium potency topical corticosteroids (only applicable for part B of the study)
  3. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
  4. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
  5. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
  6. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit
  7. History of malignancy at any time before the baseline visit
  8. Diagnosed active endoparasitic infections or at high risk of these infections
  9. Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Megha Tollefson, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20416018

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