Purpose

This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to <12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.

Condition

Eligibility

Eligible Ages
Between 6 Years and 11 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Children aged 6 to <12 years at the time of informed consent/assent. • No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. Disease Characteristics: 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[19]; and - 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); and - Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy Other Inclusion Criteria: Body weight ≥15 kg

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply: Medical Conditions: 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. A copy or summary of the evaluation should be placed in the site source documents. Have any of the following medical conditions: - Infections: - Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) 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 (single episode) 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. - Other Conditions: - 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/Concomitant Therapy: 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. Prior/Concurrent Clinical Study Experience: Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Abrocitinib
Abrocitinib administered as liquid oral suspension.
  • Drug: Abrocitinib
    Abrocitinib administered as liquid oral suspension.
    Other names:
    • PF-04965842
Placebo Comparator
Matching Placebo
Placebo administered as liquid oral suspension.
  • Other: Placebo
    Placebo administered as liquid oral suspension.

Recruiting Locations

Cahaba Dermatology & Skin Health Center, LLC
Birmingham 4049979, Alabama 4829764 35244

Arkansas Research Trials
North Little Rock 4124112, Arkansas 4099753 72117

Solutions Through Advanced Research
Jacksonville 4160021, Florida 4155751 32256

Miami Dermatology and Laser Research
Miami 4164138, Florida 4155751 33133

Dawes Fretzin Clinical Research Group, LLC
Indianapolis 4259418, Indiana 4921868 46250

Tribe Clinical Research, LLC
Greenville 4580543, South Carolina 4597040 29607

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.