Clinical trial NCT04360187: Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
Official title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 391
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).


Eligibility criteria: Inclusion Criteria:

- Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.

Exclusion Criteria:

* Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.
* Has participated in a previous crisaborole clinical study.

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29
timeFrame: Baseline, Day 29
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 60
measure: Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
timeFrame: Baseline up to Day 29
measure: Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
timeFrame: Baseline up to Day 29
Secondary outcomes:
measure: Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29
timeFrame: Baseline, Day 29
measure: Percentage of Participants Achieving Success in ISGA at Day 29
timeFrame: Baseline, Day 29
measure: Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years
timeFrame: Baseline, Week 4
measure: Percentage of Participants Achieving Success in ISGA Over Time
timeFrame: Baseline, Day 8, Day 15, Day 22, Day 29
measure: Percentage of Participants Achieving Improvement in ISGA Over Time
timeFrame: Baseline, Day 8, Day 15, Day 22, Day 29
measure: Percent Change From Baseline in EASI Total Score Over Time
timeFrame: Baseline, Day 8, Day 15, Day 22, Day 29
measure: Change From Baseline in Percent Body Surface Area (%BSA) Over Time
timeFrame: Baseline, Day 8, Day 15, Day 22, Day 29
measure: Percentage of Participants Achieving EASI-50 Over Time
timeFrame: Baseline, Day 8, Day 15, Day 22, Day 29
measure: Percentage of Participants Achieving EASI-75 Over Time
timeFrame: Baseline, Day 8, Day 15, Day 22, Day 29
measure: Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4
measure: Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4
measure: Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
timeFrame: Baseline, Day 15, Day 29
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time
timeFrame: Baseline, Day 15, Day 29
measure: Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time
timeFrame: Baseline, Day 15, Day 29
measure: Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time
timeFrame: Baseline, Day 15, Day 29
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years
timeFrame: Baseline, Day 15, Day 29
measure: Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years
timeFrame: Baseline, Day 15, Day 29
measure: Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4
measure: Patient Global Impression of Change (PGIC) Score
timeFrame: Day 8, Day 15, Day 22, Day 29
measure: Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4
measure: Observer Reported Global Impression of Change (OGIC) Score
timeFrame: Day 8, Day 15, Day 22, Day 29
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changchun
country: China
facility: The First hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Third Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital/Dermatology Department
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Wenzhou
country: China
facility: The first Affiliated hospital of Wenzhou medical University
state: Zhejiang
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Army Medical University,PLA
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
city: Matsudo City
country: Japan
facility: Miyata Dermatology Clinic
state: Chiba
city: Hiroshima-shi
country: Japan
facility: Shirao Clinic of Pediatrics and Pediatric Allergy
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Motomachi Dermatology Clinic
state: Hokkaido
city: Chitose Shi
country: Japan
facility: Chitose dermatology and plastic surgery clinic
state: Hokkaido
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Akashi-City
country: Japan
facility: Yoshimura Child Clinic
state: Hyōgo
city: Kobe-City
country: Japan
facility: Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic
state: Hyōgo
city: Yokohama-shi
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Kamimashiki-gun
country: Japan
facility: Noguchi Dermatology Clinic
state: Kumamoto
city: Neyagawa
country: Japan
facility: Yoshioka Dermatology Clinic
state: Osaka
city: Sakai-City
country: Japan
facility: Kume Clinic
state: Osaka
city: Adachi-ku
country: Japan
facility: Mildix Skin Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Yoga Allergy Clinic
state: Tokyo
city: Toshima-Ku
country: Japan
facility: Sugamo Kobayashi Derma Clinic
state: Tokyo
city: Toshima-Ku
country: Japan
facility: Sugamo Sengoku Dermatology
state: Tokyo
city: Fukuoka
country: Japan
facility: Hoshikuma Dermatology・Allergy Clinic
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: