Final Clinical Study Report
Protocol C3291027

CLINICAL STUDY REPORT SYNOPSIS
Sponsor: Pfizer, Inc.
Investigational Product: Crisaborole
Clinical Study Report Synopsis: Protocol C3291027
Protocol Title: A Phase 3, Multicenter, Open-Label Study of the Long-Term Safety ofCrisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild toModerate Atopic Dermatitis
Investigators: Refer to Appendix 16.1.4.1 for a list of investigators involved in this study.
Study Centers: This study was conducted at 15 centers in Japan. Refer toAppendix 16.1.4.1 for a list of sites involved in this study.
Publications Based on the Study: None
Study Initiation Date: 14 September 2020
Study Completion Date: 18 December 2020
The study was terminated prematurely due to the Sponsor's business decision and portfolio
reprioritization. The decision was not as a result of any safety or efficacy concerns. No
participants from Study C3291031 enrolled into this study as Study C3291031 was cancelled
due to the Sponsor's business decision before it started.
Report Date: 27 April 2021
Previous Report Date: Not Applicable
Phase of Development: Phase 3Primary and Secondary Study Objectives and Endpoints:
The study objectives, estimands, and endpoints are summarized in Table S1.

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Final Clinical Study Report
Protocol C3291027

CLINICAL STUDY REPORT SYNOPSIS
Table S1. Study Objectives, Estimands, and Endpoints
TypePrimary:
SafetyObjectives

Estimands

 To study the safety ofcrisaborole ointment,
2% applied BID inJapanese pediatric andadult participants withmild to moderate AD

 There was nodefined estimandfor this objectiveand theseendpoints wereanalyzed
descriptivelyEndpoints
 The incidence of treatment
emergent AEs and SAEs

Abbreviations: AD=atopic dermatitis; AE=adverse event; BID=twice daily; SAE=serious adverse event.

METHODS
Study Design: This study was a Phase 3, multicenter, open-label, long-term safety extension
study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants withmild to moderate atopic dermatitis (AD) to support the registration of crisaborole in Japan.
After completion of the study intervention period in Studies C3291032 or C3291031 andconfirmed Study C3291027 eligibility, participants were offered participation in the study
from investigator sites in Japan. The sample size of this study was approximately
150 participants but was determined by the number of participants who completed
Studies C3291032 or C3291031 treatment period and met eligibility criteria of this study.
Diagnosis and Main Criteria for Inclusion: Male or female participants who were patientswith mild to moderate AD aged 2 years or older and met eligibility criteria forStudy C3291032 at the time when entering Study C3291032, and completed treatment periodin Study C3291032 without safety issues; or, male or female participants who were patientswith mild to moderate AD aged 1 month to <24 months and met eligibility criteria forStudy C3291031 at the time when entering study C3291031, and completed treatment period
in Study C3291031 without safety issues were included in the study.
Participants who discontinued early from Studies C3291032 or C3291031 treatment, for any
reason; or who had a significant active systemic or localized infection, including known
actively infected AD were excluded from the study.
Study Treatment: Crisaborole ointment 2% was applied topically as an even layer twice aday (BID) based on a participant’s own AD percentage body surface area adjusted by heightand weight.
Efficacy Evaluations: Not Applicable.
Pharmacokinetic, Pharmacodynamic, Pharmacogenomic, and/or Other Evaluations:
Not Applicable.

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Protocol C3291027

CLINICAL STUDY REPORT SYNOPSIS
The median age for all 40 participants in the study was 10.5 years. The median age for<18 years of age group and ≥18 years of age group was 9.0 and 32.0 years, respectively. Outof 40 participants, 21 were male and 19 were female. All the 40 participants were Asian andnot-Hispanic or Latino.
Efficacy Results: Not Applicable.
Pharmacokinetic, Pharmacodynamic, Pharmacogenomic, Immunogenicity and/or
Other Results: Not Applicable.
Safety Results: In <18 years of age group, all 30 participants enrolled into the study
intervention period. The median duration of crisaborole ointment 2% BID treatment was29.0 days, with a range of 0 to 51 days. In ≥18 years of age group, all 10 participants
enrolled into the study intervention period. The median duration of crisaborole ointment 2%
BID treatment was 29.0 days, with a range of 14 to 56 days.
A total of 14 participants (35.0%) experienced a total of 15 all-causality treatment-emergent
adverse events (TEAEs). In <18 years of age group, 11 participants (36.7%) experienced
12 all-causality TEAEs. In ≥18 years of age group, 3 participants (30.0%) experienced
3 all-causality TEAEs. One participant (2.5%) in <18 years of age group experienced aTEAE of application site pain which was considered treatment-related. There were nodeaths, SAEs or severe AEs reported in either age group in the study. All TEAEs were mildin severity.
Incidence of Adverse Events: The all-causality TEAEs reported in the study are presented bysystem organ class and preferred term (PT) in Table S3. In <18 years of age group, the mostfrequently reported all-causality TEAEs by PT were nasopharyngitis (3 participants) anddermatitis atopic (2 participants), all other TEAEs were reported in 1 participant each. In≥18 years of age group, the all-causality TEAEs by PT were gastroenteritis, wound and joint
effusion (1 participant each).

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CLINICAL STUDY REPORT SYNOPSIS
Most TEAEs were not considered treatment-related, and did not occur in a treatment area.
One treatment-related TEAE which did occur in the treatment area was application site pain
(1 participant) which was mild in severity.
Permanent Discontinuations Due to Adverse Events: One participant in <18 years of age
group discontinued the study due to a TEAE of application site pain on the multiple
treatment areas of the face which was mild in severity and considered as treatment-related,
and the participant discontinued from the study after 13 days of treatment. This event ofapplication site pain is consistent with the known safety profile of crisaborole.
Dose Reductions or Temporary Discontinuations Due to Adverse Events: One participant in<18 years of age group had a TEAE of dermatitis atopic that led to a drug interruption. It
was not related to study treatment.
Conclusions:This study was planned to assess the 1-year-long-term safety of crisaborole ointment 2% inJapanese pediatric and adult participants with mild to moderate AD but terminated due to theSponsor's business decision and portfolio reprioritization. Most of the participants (90%)
were discontinued early from the study after completion of 1 treatment cycle and the median
duration of crisaborole ointment 2% BID treatment was 29.0 days.
There were no deaths, SAEs, or severe AEs reported in the study.
All the TEAEs reported in this study were mild in severity.
The TEAE of application site pain reported in a single participant in <18 years of age group
was considered treatment-related.
A dose reduction or temporary/permanent discontinuation due to TEAEs was reported in
1 participant in <18 years of age group in the study.
Crisaborole ointment 2% was well-tolerated in Japanese pediatric and adult participants withmild to moderate AD in BID regimens. No safety issues of concerns were identified in thisstudy. The safety profile observed in this study is consistent with that observed in previousstudies.

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