A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Crisaborole ointment 2%	Phase 4

Detailed Description:

Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD-involved, excluding the scalp.

In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA, excluding the scalp, and must complete all PK assessments to be included in the PK analysis. Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled. Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments. Only selected study sites will participate in the PK assessment.

Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28 days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination), Day 36, and Day 57 (end of study).

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	125 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A PHASE 4, MULTICENTER, OPEN-LABEL SAFETY STUDY OF CRISABOROLE OINTMENT 2% IN CHILDREN AGED 3 MONTHS TO LESS THAN 24 MONTHS WITH MILD TO MODERATE ATOPIC DERMATITIS
Actual Study Start Date :	January 16, 2018
Estimated Primary Completion Date :	April 11, 2019
Estimated Study Completion Date :	April 11, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Crisaborole ointment 2%; Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.	Drug: Crisaborole ointment 2%; Applied BID; Other Name: Eucrisa

Outcome Measures

Primary Outcome Measures :

1. Number of subjects with incidence of treatment adverse events and serious adverse events [ Time Frame: Screening ]
   Incidence of treatment emergent AEs (including application site reactions) and SAEs. The investigator is to record all directly observed AE's and all AEs spontaneously reported by the subject's parent(s) / legal guardian. In addition, each study subject's parent(s) / legal guardian will be questioned about the occurence of AEs in a non-leading manner.
2. Number of subjects with clinically significant change from baseline in height / length in (cm) [ Time Frame: Day 1 (Baseline), Day 29 (end of treatment/early termination) ]
   Standing height will be measured using a wall mounted device or alternatively, Length is measured from top of the head to the heel of one foot. Clinical significance will be determined at the investigator's discretion.
3. Number of subjects with clinically significant change from baseline in weight (kg) [ Time Frame: Screening, Day 1 (Baseline), Day 29 (end of treatment/early termination). ]
   Weight will be measured using a scale with appropriate range and resolution which must be placed on a stable, flat surface. Subjects must remove shoes, bulky layers of clothing and jackets so that only light clothing remains. Clinical significance will be determined at the investigator's discretion.
4. Number of subjects with clinically significant changes from baseline in Vital Signs [ Time Frame: Screening, Day 1 (Baseline), Day 8, Day 15, Day 29 (end of treatment/early termination) ]
   Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) will be obtained with participant in the seated or supine position, after the subject has been seated or lying face up for 5 minutes. Clinical significance of vital signs will be determined at the investigator's discretion.
5. Number of subjects with clinically significant changes from baseline in ECG. [ Time Frame: Screening OR Day 1 (Baseline), Day 8, Day 29 (end of treatment/early termination) ]
   A single supine 12-lead ECG will be performed at each of the timepoints. Assessment should be performed after the subject has rested quietly and precede measurements of vital signs and blood draws. ECG interpretation will be provided to the site by a central reader, assessing relevance of abnormal findings. The investigator will assess the findings based on the subject's clinical presentation and determine clinical significance for a given subject.
6. Number of subjects with change from baseline in clinical laboratory parameters. [ Time Frame: Screening, Day 29 (end of treatment/early termination) ]
   Laboratory parameters includes: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, glucose non-fasting, creatinine, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein, lactate, calculation of osmolal gap and calculation of anion gap). Clinical significance of laboratory parameters will be determined at the investigator's discretion.
7. Number of subjects with incidence of treatment adverse events and serious adverse events [ Time Frame: Day 1 (Baseline) ]
   Incidence of treatment emergent AEs (including potential hypersensitivity and/or application site reactions) and SAEs. The investigator is to record all directly observed AE's and all AEs spontaneously reported by the subject's parent(s) / legal guardian. In addition, each study subject's parent(s) / legal guardian will be questioned about the occurence of AEs in a non-leading manner.
8. Number of subjects with incidence of treatment adverse events and serious adverse events [ Time Frame: Day 8 ]
   Incidence of treatment emergent AEs (including potential hypersensitivity and/or application site reactions) and SAEs. The investigator is to record all directly observed AE's and all AEs spontaneously reported by the subject's parent(s) / legal guardian. In addition, each study subject's parent(s) / legal guardian will be questioned about the occurence of AEs in a non-leading manner.
9. Number of subjects with incidence of treatment adverse events and serious adverse events [ Time Frame: Day 15 ]
   Incidence of treatment emergent AEs (including potential hypersensitivity and/or application site reactions) and SAEs. The investigator is to record all directly observed AE's and all AEs spontaneously reported by the subject's parent(s) / legal guardian. In addition, each study subject's parent(s) / legal guardian will be questioned about the occurence of AEs in a non-leading manner.
10. Number of subjects with incidence of treatment adverse events and serious adverse events [ Time Frame: Day 22 ]
    Incidence of treatment emergent AEs (including potential hypersensitivity and/or application site reactions) and SAEs. The investigator is to record all directly observed AE's and all AEs spontaneously reported by the subject's parent(s) / legal guardian. In addition, each study subject's parent(s) / legal guardian will be questioned about the occurence of AEs in a non-leading manner.
11. Number of subjects with incidence of treatment adverse events and serious adverse events [ Time Frame: Day 29 (end of treatment/early termination) ]
    Incidence of treatment emergent AEs (including potential hypersensitivity and/or application site reactions) and SAEs. The investigator is to record all directly observed AE's and all AEs spontaneously reported by the subject's parent(s) / legal guardian. In addition, each study subject's parent(s) / legal guardian will be questioned about the occurence of AEs in a non-leading manner.
12. Number of subjects with incidence of treatment adverse events and serious adverse events [ Time Frame: Day 36 ]
    Incidence of treatment emergent AEs (including potential hypersensitivity and/or application site reactions) and SAEs. The investigator is to record all directly observed AE's and all AEs spontaneously reported by the subject's parent(s) / legal guardian. In addition, each study subject's parent(s) / legal guardian will be questioned about the occurence of AEs in a non-leading manner.
13. Number of subjects with incidence of treatment adverse events and serious adverse events [ Time Frame: Day 57 (End of study) ]
    Incidence of treatment emergent AEs (including potential hypersensitivity and/or application site reactions) and SAEs. The investigator is to record all directly observed AE's and all AEs spontaneously reported by the subject's parent(s) / legal guardian. In addition, each study subject's parent(s) / legal guardian will be questioned about the occurence of AEs in a non-leading manner.

Eligibility Criteria

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Ages Eligible for Study:	3 Months to 23 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD

Exclusion Criteria:

Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)

Contacts and Locations

Contacts

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

  Show 35 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here.  To obtain contact information for a study center near you, click here. 

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Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT03356977 History of Changes
Other Study ID Numbers:	C3291002; CARE 1 ( Other Identifier: Alias Study Number )
First Posted:	November 29, 2017
Last Update Posted:	March 5, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL:	https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic	Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases