A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

NCT ID: NCT03539601

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-27
• Study Completion Date: 2020-12-11

Brief Summary

This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD.

A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to <18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.

Detailed Description

Approximately 600 subjects will be enrolled in the study, of which at least 150 subjects aged 2-6; at least 140 subjects aged 7-11; at least 120 subjects aged 12-17 and up to 90 subjects will be adults. Subjects must have mild-moderate AD involving at least 5% treatable %BSA assessed on baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD involved, excluding the scalp.

Eligible subjects will be randomized at the Baseline/Day 1 visit. Randomization will be stratified by eligibility for TCS or TCI treatment as per national approved labels. Cohort 1 will be for subjects who are eligible for TCS therapy, and Cohort 2 will be for subjects who are not eligible for TCS therapy but eligible for TCI therapy. The investigational products will be applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1.

The primary efficacy endpoint is the percent change from baseline in the Eczema Area and Severity Index (EASI) total score at Day 29.

For the efficacy comparison of crisaborole versus vehicle, subjects from both Cohort 1 and Cohort 2 are included in the analysis, adjusted for cohort effect. For the efficacy comparison of crisaborole versus TCS, only subjects from Cohort 1 are included in the analysis. For the comparison of crisaborole versus TCI, only subjects from Cohort 2 are included in the analysis.

Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.

Scheduled study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (End of treatment/Early termination), Day 43 or 14 Days after last dose if subject is terminated early from treatment. A follow up telephone call will be made by site staff to the subjects/subject's legally acceptable guardian(s) on Day 60 or at least 28 days after last dose if subject is terminated early from treatment. The Day 60 visit will be completed in the clinic for subjects enrolled in the OCT sub-study.

To further explore the benefit/risk of crisaborole ointment, 2%, a sub-study to evaluate differences in atrophic skin changes across study treatment groups in Cohort 1 will be conducted at select sites.

The sub-study will include obtaining Optical coherence tomography (OCT) imaging to evaluate atrophic changes in epidermal thickness during and after treatment with study investigational product in Cohort 1. This sub-study also provides an opportunity to explore differences in Transepidermal Water Loss (TEWL) and cutaneous inflammatory and barrier biomarkers associated with AD within the stratum corneum (SC) across treatment groups in Cohort 1. The Aquaflux (an evaporimeter) will be used in this sub-study to evaluate TEWL during and after treatment at select sub-study centers. Tape-strips will also be used in this sub-study to evaluate SC biomarkers from AD lesional and non-lesional skin.

This sub-study will include approximately 60 subjects from Cohort 1 that are enrolled in the main study (C3291037). Subjects will follow the main study assessments and visits as per the schedule of activities for the main study but will also follow additional procedures as described in the protocol. The telephone call at Day 60 in the main study is replaced with an in-clinic visit for sub-study participants.

Conditions

Atopic Dermatitis

Study Design

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

Study Groups

Crisaborole ointment, 2%

This treatment arm will be administered both in Cohort 1 and Cohort 2.

Group Type: EXPERIMENTAL

Crisaborole ointment, 2%

Intervention Type: DRUG

Applied twice a day (BID)

Hydrocortisone butyrate cream, 0.1%

This treatment arm will be administered in Cohort 1 only.

Group Type: ACTIVE_COMPARATOR

Hydrocortisone butyrate cream, 0.1%

Intervention Type: DRUG

Applied BID

Pimecrolimus cream, 1%

This treatment arm will be administered in Cohort 2 only.

Group Type: ACTIVE_COMPARATOR

Pimecrolimus cream, 1%

Intervention Type: DRUG

Applied BID

Crisaborole Vehicle

This treatment arm will be administered both in Cohort 1 and Cohort 2.

Group Type: PLACEBO_COMPARATOR

Crisaborole Vehicle

Intervention Type: DRUG

Applied BID

Interventions

Crisaborole ointment, 2%

Applied twice a day (BID)

Intervention Type: DRUG

Hydrocortisone butyrate cream, 0.1%

Applied BID

Intervention Type: DRUG

Pimecrolimus cream, 1%

Applied BID

Intervention Type: DRUG

Crisaborole Vehicle

Applied BID

Intervention Type: DRUG

Other Intervention Names

Eucrisa; Locoid 0.1%; Elidel

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.

Subjects in Cohort 1 are excluded if they have a contraindication for treatment with hydrocortisone butyrate cream 0.1%

Subjects in Cohort 2 are excluded if they have a contraindication for treatment with pimecrolimus cream, 1%

• Minimum Eligible Age: 2 Years
• 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

Dermatology Trial Associates

Bryant, Arkansas, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Park Avenue Dermatology

Orange Park, Florida, United States

Lenus Research & Medical Group, LLC

Sweetwater, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

DS Research

Louisville, Kentucky, United States

M3-Wake Research, Inc.

Raleigh, North Carolina, United States

Arlington Research Center, Inc.

Arlington, Texas, United States

Tanner Clinic

Layton, Utah, United States

Virginia Clinical Research, Inc

Norfolk, Virginia, United States

Klinikum der Universitat Munchen

München, Bavaria, Germany

Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz

Bad Bentheim, Lower Saxony, Germany

Universitatsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Universitatsklinikum Schleswig-Holstein, Campus Lubeck

Lübeck, Schleswig-Holstein, Germany

ISA - Interdisciplinary Study Association GmbH

Berlin, , Germany

Universitaetsklinikum Frankfurt

Frankfurt am Main, , Germany

UOSD Dermatologia Gen. ed Oncologica DU, PO San Salvatore

L’Aquila, AQ, Italy

DiSSal Sezione di Dermatologia Az. Ospedaliera Universitaria

Genova, GE, Italy

Ospedale San Pietro Fatebenefratelli

Roma, RM, Italy

Azienda Ospedaliero - Universitaria Policlinico Tor Vergata

Roma, ROME, Italy

Barbara Rewerska Diamond Clinic

Krakow, Malopolska, Poland

Silmedic sp. z o.o

Katowice, , Poland

Krakowskie Centrum Medyczne sp. z o.o.

Krakow, , Poland

Klinika Ambroziak Sp. z O. O.

Warsaw, , Poland

ROYALDERM Agnieszka Nawrocka

Warsaw, , Poland

Barn och Ungdomskliniken

Örebro, , Sweden

Avdelningen for Kliniska Provningar

Örebro, , Sweden

Universitatsklinik fuer Dermatologie

Bern, , Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Universitats-Kinderspital Zurich

Zurich, , Switzerland

Rame Medical Ltd, Penntorr Health

Torpoint, Cornwall, United Kingdom

NHS Tayside, Ninewells Hospital and Medical School

Dundee, Scotland, United Kingdom

Countries

United States; Germany; Italy; Poland; Sweden; Switzerland; United Kingdom

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=C3291037

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

Other Identifiers

2018-001043-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C3291037

Identifier Type: -

Identifier Source: org_study_id