Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis

Pfizer763 enrolled

Overview

The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

763

Conditions

Dermatitis, Atopic

Interventions

AN2728 Topical Ointment, 2%DRUG

Matching vehicle controlDRUG

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females 2 years and older * Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka * Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp) * Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1 * All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug Exclusion Criteria: * As determined by the study doctor, a medical history that may interfere with study objectives * Unstable AD or any consistent requirement for high potency topical corticosteroids * History of use of biologic therapy (including intravenous immunoglobulin) * Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD * Recent or current participation in another research study * Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study * Participation in a previous AN2728 clinical trial

Locations (1)

Anacor Investigational Site

Stockbridge, Georgia, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29

ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.

Time frame: Day 29

Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.

Time frame: AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36

Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29

Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position. Clinical significance of change from baseline value was determined by investigator.

Time frame: Baseline, Day 29

Data from ClinicalTrials.gov

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Secondary Outcomes

Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29

ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.

Time frame: Day 29

Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA)

Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.

Time frame: Baseline (Day 1) up to Day 29

Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29

Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.

Time frame: Baseline, Day 29