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A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
150 patients around the world
Available in United States, Mexico
Different questionnaires will be used to find out how the participant's eczema is doing
during the research study. An electronic diary, which looks like a cellular phone, will
be used to collect the questionnaire information and other research study-related
information. It will also be used to remind participants to take the test medicine each
day and to fill out the questionnaires. Participants will also be asked to wear something
on their wrist that looks like a children's wristwatch so we can know when they are
scratching their skin because of their atopic dermatitis. Laboratory tests, physical
examinations and vital signs (height, weight, temperature, blood pressure and heart rate)
will be conducted before and during the research study to monitor your child's health.
Participants will need to come to the clinic for research study visits and at other times
during the research study, the research study doctor or nurse will call the participants
to find out the participant is doing.
Pfizer
1Research sites
150Patients around the world
This study is for people with
Eczema
Dermatitis
Atopic dermatitis
Requirements for the patient
To 11 Years
All Gender
Medical requirements
- Children aged 6 to 12 years at the time of informed consent/assent.No contraception methods are required for male participants.Participants who meet all of the following AD criteria.A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria.A diagnosis of moderate-to-severe AD at the baseline visit must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4.Documented history within 6 months of the screening visit of inadequate response to treatment with topical medical therapy for AD for at least 4 weeks and are candidates for systemic therapy.Body weight ≥15 kg.
- Participants are excluded from the study if any of the following criteria apply.Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study.Have any of the following medical conditions.Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 or have superficial skin infections within 1 week of Day 1.History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.Have a history of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.Infection with HIV, hepatitis B, and/or hepatitis C.Evidence of active TB or inadequately treated latent TB.Skin Conditions: Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.Documented history of skeletal dysplasia.Documented history of retinal detachment.History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.Prior history of leukemia, lymphoma, sarcoma or any other malignancy.Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.Prior treatment with a systemic JAK inhibitor for AD.Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.
Sites
Servicios Hospitalarios de México, S.A. de C.V.
SponsorPfizer
Study typeInterventional
Conditions
EczemaAtopic dermatitis
Requirements
To 11 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06807268
