A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis

A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment

This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Crisaborole 2%; Drug: Vehicle

Detailed Description

Approximately 700 participants will be enrolled in an run-in period to receive crisaborole, BID for up to a maximum of 8 weeks to identify crisaborole responders. A responder is defined as a participant who achieves both ISGA and EASI50 success. ISGA success is defined as achieving a score of 0 or 1 with at least 2 grade improvement from baseline; and the EASI50 success is defined as at least 50% improvement from baseline. Non responders at the end of the 8-week run-in period will be discontinued from the study.

Approximately 250 responders will be randomized (1:1 ratio) to enter the double-blind maintenance treatment period to receive crisaborole or vehicle QD for 52 weeks, with follow-up assessments every 4 weeks. If a flare occurs and if the participant meets the criteria for having a flare (ISGA ≥2), the participant will switch to enter a flare treatment period to receive open-label crisaborole BID for up to 12 weeks with follow-up assessments every 4 weeks. If the flare has resolved (ISGA ≤1) the participant will resume maintenance treatment and respective visit schedule. If a flare does not resolve after 3 consecutive treatment courses the participant will discontinue the study. A flare treatment period may comprise up to 3 consecutive treatment courses with crisaborole BID (each course is 4 weeks).

An end of study (EOS) safety follow-up is required 4 weeks after the last study treatment of any treatment period.

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Maroubra, New South Wales, Australia, 2035
      • Australian Clinical Research Network
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Center
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research , Inc
    • North York, Ontario, Canada, M2M 4J5
      • North York Research Inc.
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research Toronto
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Skinsense Medical Research
• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital Of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Dermatology Hospital of Jiangxi Province
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Fudan University/Dermatology Department
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310009
      • Hangzhou Third Hospital
• Israel
  • Ramat - Gan, Israel, 5265601
    • The Chaim Sheba Medical Center
• Turkey
  • Istanbul, Turkey, 34093
    • Bezmialem Vakıf University Medical Faculty
  • Kayseri, Turkey, 38039
    • Erciyes University Medical Faculty
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates, PC
    • Colorado Springs, Colorado, United States, 80910
      • Colorado Springs Dermatology Clinic, PC
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research LLC
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc
    • Largo, Florida, United States, 33770
      • Olympian Clinical Research
    • Miami, Florida, United States, 33137
      • Baumann Cosmetic and Research Institute
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center, PC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Meridian Clinical Research, LLC
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Tulsa, Oklahoma, United States, 74127
      • Oklahoma State University - Center for Health Sciences
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Fort Worth, Texas, United States, 76244
      • Innovate Research, LLC
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, Inc.
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD. LLP
  • Utah
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology Center
  • Virginia
    • Burke, Virginia, United States, 22015
      • PI-Coor Clinical Research LLC
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane
    • Spokane, Washington, United States, 99204
      • Principle Research Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female
• 3 months of age and older
• Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
• Minimum of 5% BSA affected by atopic dermatitis
• ISGA score of Mild (2) or Moderate (3)

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crisaborole 2%; Crisaborole 2% ointment applied once daily (QD)	Drug: Crisaborole 2%; Crisaborole ointment 2%
Placebo Comparator: Vehicle; Vehicle ointment applied once daily (QD)	Drug: Vehicle; Vehicle ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flare-free maintenance	Flare-free maintenance up until the onset of the first flare during the maintenance period. A flare is defined as a score of 2 or more on the Investigator Static Global Assessment (ISGA).	52 Weeks
Incidence of treatment emergent adverse events	Incidence of treatment emergent adverse events over 52 weeks	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of flare-free days	Number of flare-free days over 52 weeks	52 Weeks
Number of flares	Number of flares over 52 weeks	52 Weeks
Pruritus response maintenance	Maintenance of pruritus scores of ≥50% until onset of first flare. A flare is defined as a score of ≥2 on the Investigator's Static Global Assessment (ISGA).	52 Weeks
Eczema Area and Severity Index (EASI) response maintenance	Maintenance of ≥50% reduction in Eczema Area and Severity Index (EASI50) over 52 weeks	52 weeks
Patient-reported outcome response maintenance	Maintenance of Dermatology Quality of Life Assessments (DQoL) over 52 weeks	52 weeks
Patient-reported outcome response maintenance	Maintenance of Patient Oriented Eczema Measure (POEM) over 52 weeks	52 weeks
Severity of flares	Severity of flare on Investigator's Static Global Assessment (ISGA)	52 weeks
Severity of flares	Severity of flare on Eczema Area and Severity Index (EASI)	52 weeks
Duration of flares	Duration of flare episodes over 52 weeks	52 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Actual): January 19, 2022
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Eczema; Crisaborole
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: C3291035; 2019-000443-28 (EudraCT Number); CRISADE CONTROL (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No