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

NCT03539601 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: C32910372018-001043-31
• Study Type: interventional
• Target: 237
• Locations: 7 countries
• Sites: 32

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis, Crisaborole ointment 2%, TCS, TCI

Outcome Measures

Primary Outcomes (5)

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

  EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and percent (%) body surface area (%BSA) affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae, groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) based upon %BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%), 6 (90 to 100%). Total EASI score (aged \>=8 years) =0.1\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + Exu + Lu) + 0.3\*At\*(Et + It +Ext + Lt) + 0.4\*Al\*(El + Il + Exl + Ll); for aged 2 to \<8 years =0.2\*Ah\*(Eh + Ih + Exh + Lh) + 0.2\*Au\*(Eu + Iu + Exu + Lu) + 0.3\*At\*(Et +It + Ext + Lt) + 0.3\*Al\*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.

  Baseline, Day 29

• Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Discontinuations Due to AEs and SAEs

  An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs are events between the first dose of study drug up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A SAE is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event.

  From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days)

• Number of Participants With Local Tolerability Adverse Events (AEs)

  Local tolerability AEs included application and instillation site reactions, application site discharge, application site erythema, application site exfoliation, application site pain, application site pruritus, application site swelling, dermatitis and eczema, dermatitis atopic, dermatitis contact, eczema, skin irritation, telangiectasia and related conditions, and urticarias.

  From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days)

• Number of Participants With Clinically Significant Changes in Vital Signs

  Vital sign measurements included temperature, respiratory rate, pulse rate, and blood pressure. Temperature, respiratory rate, pulse rate, and blood pressure were taken in the seated or supine position, after the participant has been sitting or lying calmly for a minimum of 5 minutes (when possible for younger children). Position of recording was consistent within participant through-out the study.

  Screening up to Day 29

• Number of Participants With Clinically Significant Abnormal Laboratory Parameters

  Hematology parameters included with criteria greater than (\>) 1.2\*upper limit of normal (ULN): leukocytes (10\^3 per cubic millimeter \[10\^3/mm\^3\]), lymphocytes (10\^3/mm\^3), lymphocytes/leukocytes (%), neutrophils (10\^3/mm\^3), neutrophils/leukocytes (%), basophils/leukocytes (%), eosinophils (10\^3/mm\^3), eosinophils/leukocytes (%), monocytes (10\^3/mm\^3), monocytes/leukocytes (%). Clinical chemistry included parameters: aspartate aminotransferase (units per liter \[U/L\]) (\>3.0\* ULN), alanine aminotransferase (U/L) (\>3.0\* ULN), alkaline phosphatase (U/L) (\>3.0\* ULN), creatinine (milligram per deciliter \[mg/dL\]) (\>1.3\* ULN), potassium (milliequivalent per liter \[mEq/L\]) (\>1.1\* ULN), bicarbonate (mEq/L) (\>1.1\* ULN).

  Screening up to Day 29

Secondary Outcomes (20)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15 and 22

  Baseline, Day 8, 15 and 22

• Number of Participants Who Achieved Success in the Investigator's Static Global Assessment (ISGA) (ISGA Score of Clear [0] or Almost Clear [1] With At-least a 2-Grade Improvement From Baseline) at Day 8, 15, 22 and 29

  Day 8, 15, 22 and 29

• Number of Participants Who Achieved Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 8, 15, 22 and 29

  Day 8, 15, 22 and 29

• Number of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15, 22 and 29

  Day 8, 15, 22 and 29

• Time to First Improvement From Baseline in Eczema Area and Severity Index (EASI) Total Score of Greater Than or Equal to (>=) 75%

  Baseline up to Day 43

Study Arms (4)

Crisaborole ointment, 2%

EXPERIMENTAL

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

Drug: Crisaborole ointment, 2%

Hydrocortisone butyrate cream, 0.1%

ACTIVE COMPARATOR

This treatment arm will be administered in Cohort 1 only.

Drug: Hydrocortisone butyrate cream, 0.1%

Pimecrolimus cream, 1%

ACTIVE COMPARATOR

This treatment arm will be administered in Cohort 2 only.

Drug: Pimecrolimus cream, 1%

Crisaborole Vehicle

PLACEBO COMPARATOR

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

Drug: Crisaborole Vehicle

Interventions

Crisaborole ointment, 2% DRUG

Applied twice a day (BID)

Also known as: Eucrisa

Crisaborole ointment, 2%

Hydrocortisone butyrate cream, 0.1% DRUG

Applied BID

Also known as: Locoid 0.1%

Hydrocortisone butyrate cream, 0.1%

Pimecrolimus cream, 1% DRUG

Applied BID

Also known as: Elidel

Pimecrolimus cream, 1%

Crisaborole Vehicle DRUG

Applied BID

Crisaborole 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.
• 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%

Sponsors & Collaborators

• Pfizer: lead

Study Sites (32)

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Lenus Research & Medical Group, LLC

Sweetwater, Florida, 33172, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

M3-Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Virginia Clinical Research, Inc

Norfolk, Virginia, 23502, United States

Location

Klinikum der Universitat Munchen

München, Bavaria, 80337, Germany

Location

Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Universitatsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitatsklinikum Schleswig-Holstein, Campus Lubeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

UOSD Dermatologia Gen. ed Oncologica DU, PO San Salvatore

L’Aquila, AQ, 67100, Italy

Location

DiSSal Sezione di Dermatologia Az. Ospedaliera Universitaria

Genova, GE, 16132, Italy

Location

Ospedale San Pietro Fatebenefratelli

Roma, RM, 00189, Italy

Location

Azienda Ospedaliero - Universitaria Policlinico Tor Vergata

Roma, ROME, 00133, Italy

Location

Barbara Rewerska Diamond Clinic

Krakow, Malopolska, 31559, Poland

Location

Silmedic sp. z o.o

Katowice, 40-282, Poland

Location

Krakowskie Centrum Medyczne sp. z o.o.

Krakow, 31-501, Poland

Location

Klinika Ambroziak Sp. z O. O.

Warsaw, 02-953, Poland

Location

ROYALDERM Agnieszka Nawrocka

Warsaw, 02-962, Poland

Location

Barn och Ungdomskliniken

Örebro, 701 85, Sweden

Location

Avdelningen for Kliniska Provningar

Örebro, 703 62, Sweden

Location

Universitatsklinik fuer Dermatologie

Bern, 3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1004, Switzerland

Location

Universitats-Kinderspital Zurich

Zurich, 8032, Switzerland

Location

Rame Medical Ltd, Penntorr Health

Torpoint, Cornwall, PL11 2TB, United Kingdom

Location

NHS Tayside, Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Mandibulofacial Dysostosis

Interventions

crisaborole; pimecrolimus

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; Craniofacial Dysostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Coloboma; Eye Diseases, Hereditary; Eye Diseases; Congenital Abnormalities

Limitations and Caveats

Study was terminated early by sponsor. Decision was not due to safety/efficacy concerns, but was related to business, portfolio reprioritization. Sub-study planned as per Amendment 3 was not initiated, as sub study site setup didn't complete prior to study termination.

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

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 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigational products above are masked for appearance, and will be placed into identical cartons. Once removed from the product cartons, the investigational products could be discerned from each other based on commercial product tube shape/size and should only be handled by unblinded site personnel. Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: April 27, 2018
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: January 10, 2022
• Results First Posted: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

SE (2); CH (3); GB (2); DE (6); IT (4); US (10); PL (5)