Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis

NCT04360187 | Completed Phase 3 Results FDA Drug

• 1 other identifier: C3291032
• Study Type: interventional
• Target: 391
• Locations: 3 countries
• Sites: 39

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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29

  The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

  Baseline, Day 29

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  An adverse event was considered as a treatment-emergent adverse event (TEAE) if the event started after the first dose of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.

  Baseline up to Day 60

• Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

  Laboratory parameters included: hematology and chemistry. Clinically significant laboratory abnormalities are defined as abnormal values that have clinical manifestations or require medical intervention. Clinically significant laboratory criteria included Hemoglobin \<0.8 x lower limit of normal (LLN), Leukocytes \>1.5 x upper limit of normal (ULN), Lymphocytes \<0.8 x LLN, Lymphocytes/Leukocytes \>1.2 x ULN, Neutrophils \<0.8 x LLN, Neutrophils \>1.2x ULN, Neutrophils/Leukocytes \<0.8 x LLN, Basophils/Leukocytes \>1.2 x ULN, Eosinophils \>1.2 x ULN, Eosinophils/Leukocytes \>1.2 x ULN, Monocytes \>1.2 x ULN, Monocytes/Leukocytes (%) \>1.2 x ULN, Bicarbonate \<0.9 x LLN, and Glucose \>1.5x ULN.

  Baseline up to Day 29

• Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs

  Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participants in the seated position, after having sat/lied calmly for at least 5 minutes. Clinically significant vital signs criteria included Diastolic Blood Pressure (DBP) Value \<50 mmHg, DBP Change ≥20 mmHg increase, DBP Change ≥20 mmHg decrease, Pulse Rate Value \>120 beats per minute (bpm), Systolic Blood Pressure (SBP) Value \<90 mmHg, SBP Change ≥30 mmHg increase, SBP Change ≥30mmHg decrease

  Baseline up to Day 29

Secondary Outcomes (22)

• Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29

  Baseline, Day 29

• Percentage of Participants Achieving Success in ISGA at Day 29

  Baseline, Day 29

• Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years

  Baseline, Week 4

• Percentage of Participants Achieving Success in ISGA Over Time

  Baseline, Day 8, Day 15, Day 22, Day 29

• Percentage of Participants Achieving Improvement in ISGA Over Time

  Baseline, Day 8, Day 15, Day 22, Day 29

Study Arms (2)

Crisaborole ointment

EXPERIMENTAL

Crisaborole ointment application twice daily for 28 days

Drug: Crisaborole Ointment

Crisaborole Placebo Vehicle

PLACEBO COMPARATOR

Vehicle Ointment application twice daily for 28 days

Drug: Crisaborole Placebo Vehicle

Interventions

Crisaborole Ointment DRUG

Crisaborole ointment 2%

Crisaborole ointment

Crisaborole Placebo Vehicle DRUG

Placebo for crisaborole ointment

Crisaborole Placebo Vehicle

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (39)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

Location

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518026, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The First hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin

Jinan, Shandong, 250022, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Hangzhou Third Hospital

Hangzhou, Zhejiang, 310009, China

Location

Zhejiang Provincial People's Hospital/Dermatology Department

Hangzhou, Zhejiang, 310014, China

Location

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

The first Affiliated hospital of Wenzhou medical University

Wenzhou, Zhejiang, 325000, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Beijing Children's Hospital, Capital Medical University

Beijing, 100045, China

Location

The Second Affiliated Hospital of Army Medical University,PLA

Chongqing, 400037, China

Location

Children's Hospital of Shanghai

Shanghai, 200062, China

Location

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, 300120, China

Location

Miyata Dermatology Clinic

Matsudo, Chiba, 271-0092, Japan

Location

Shirao Clinic of Pediatrics and Pediatric Allergy

Hiroshima, Hiroshima, 734-0023, Japan

Location

Motomachi Dermatology Clinic

Asahikawa-shi, Hokkaido, 070-0810, Japan

Location

Chitose dermatology and plastic surgery clinic

Chitose Shi, Hokkaido, 066-0021, Japan

Location

Takagi Dermatological Clinic

Obihiro, Hokkaido, 080-0013, Japan

Location

Yoshimura Child Clinic

Akashi, Hyōgo, 674-0068, Japan

Location

Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic

Kobe, Hyōgo, 658-0082, Japan

Location

Nomura Dermatology Clinic

Yokohama, Kanagawa, 221-0825, Japan

Location

Noguchi Dermatology Clinic

Kamimashiki-gun, Kumamoto, 861-3101, Japan

Location

Yoshioka Dermatology Clinic

Neyagawa, Osaka, 572-0838, Japan

Location

Kume Clinic

Sakai, Osaka, 593-8324, Japan

Location

Mildix Skin Clinic

Adachi-ku, Tokyo, 120-0034, Japan

Location

Yoga Allergy Clinic

Setagaya-ku, Tokyo, 158-0097, Japan

Location

Sugamo Kobayashi Derma Clinic

Toshima-Ku, Tokyo, 170-0002, Japan

Location

Sugamo Sengoku Dermatology

Toshima-Ku, Tokyo, 170-0002, Japan

Location

Hoshikuma Dermatology・Allergy Clinic

Fukuoka, 814-0171, Japan

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Related Publications (1)

• Ma L, Tao X, Liu S, Cheng H, Fang R, Zhao Y, Cha A, Encinas GA, Zhou Y, Deng Y, Zhang J. Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged >/= 2 Years with Mild to Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 May;14(5):1229-1243. doi: 10.1007/s13555-024-01156-6. Epub 2024 May 15.

  PMID: 38748345 DERIVED

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 24, 2020
• Study Start: July 27, 2020
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: June 7, 2022
• Results First Posted: May 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (1); CN (22); JP (16)