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

NCT ID: NCT04040192

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2022-01-19

Brief Summary

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.

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Crisaborole 2%

Crisaborole 2% ointment applied once daily (QD)

Group Type: EXPERIMENTAL

Crisaborole 2%

Intervention Type: DRUG

Crisaborole ointment 2%

Vehicle

Vehicle ointment applied once daily (QD)

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle ointment

Interventions

Crisaborole 2%

Crisaborole ointment 2%

Intervention Type: DRUG

Vehicle

Vehicle ointment

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

First OC Dermatology

Fountain Valley, California, United States

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, United States

Colorado Springs Dermatology Clinic, PC

Colorado Springs, Colorado, United States

Skin Care Research LLC

Boca Raton, Florida, United States

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, United States

Olympian Clinical Research

Largo, Florida, United States

Baumann Cosmetic and Research Institute

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Skin Specialists PC

Omaha, Nebraska, United States

Ohio Pediatric Research Association, Inc.

Dayton, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Oklahoma State University - Center for Health Sciences

Tulsa, Oklahoma, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Innovate Research, LLC

Fort Worth, Texas, United States

Austin Institute for Clinical Research

Houston, Texas, United States

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States

Center for Clinical Studies, LTD. LLP

Webster, Texas, United States

Jordan Valley Dermatology Center

South Jordan, Utah, United States

PI-Coor Clinical Research LLC

Burke, Virginia, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

Principle Research Solutions

Spokane, Washington, United States

Australian Clinical Research Network

Maroubra, New South Wales, Australia

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Milestone Research , Inc

London, Ontario, Canada

North York Research Inc.

North York, Ontario, Canada

Manna Research Toronto

Toronto, Ontario, Canada

Skinsense Medical Research

Saskatoon, Saskatchewan, Canada

Peking University First Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

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

Wuhan, Hubei, China

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China

Huashan Hospital Fudan University/Dermatology Department

Shanghai, Shanghai Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Hangzhou Third Hospital

Hangzhou, Zhejiang, China

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

Hangzhou, Zhejiang, China

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Bezmialem Vakıf University Medical Faculty

Istanbul, , Turkey (Türkiye)

Erciyes University Medical Faculty

Kayseri, , Turkey (Türkiye)

Countries

United States; Australia; Canada; China; Israel; Turkey (Türkiye)

References

Eichenfield LF, Stein Gold LF, Lynde C, Guenther L, Greenberger S, Chu CY, Ghodsi Z, Vlahos B, Sanders P, Cha A, Canosa JM. Maintenance of Investigator's Static Global Assessment Response with Once-Daily Crisaborole in Participants with Mild to Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Apr;14(4):875-892. doi: 10.1007/s13555-024-01129-9. Epub 2024 Mar 28.

Reference Type: DERIVED

PMID: 38546803 (View on PubMed)

Eichenfield LF, Gower RG, Xu J, Alam MS, Su JC, Myers DE, Sanders P, Vlahos B, Zang C, Lan J, Werth J. Once-Daily Crisaborole Ointment, 2%, as a Long-Term Maintenance Treatment in Patients Aged >/= 3 Months with Mild-to-Moderate Atopic Dermatitis: A 52-Week Clinical Study. Am J Clin Dermatol. 2023 Jul;24(4):623-635. doi: 10.1007/s40257-023-00780-w. Epub 2023 May 15.

Reference Type: DERIVED

PMID: 37184828 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3291035

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Other Identifiers

2019-000443-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRISADE CONTROL

Identifier Type: OTHER

Identifier Source: secondary_id

C3291035

Identifier Type: -

Identifier Source: org_study_id