Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

NCT01602341 | Completed Phase 2 Results

• 1 other identifier: AN2728-AD-204
• Study Type: interventional
• Target: 86
• Locations: 2 countries
• Sites: 17

Brief Summary

The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (4)

• Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8

  ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

  Baseline, Day 8

• Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15

  ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

  Baseline, Day 15

• Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22

  ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

  Baseline, Day 22

• Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29

  ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.

  Baseline, Day 29

Secondary Outcomes (6)

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  Baseline up to Day 29

• Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

  Baseline up to Day 29

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

  Baseline up to Day 29

• Number of Participants With Treatment-Emergent Adverse Events By Severity

  Baseline up to Day 29

• Number of Participants With Local Tolerability Symptoms

  Baseline up to Day 29

Study Arms (2)

AN2728 Topical Ointment, 2% QD vs 0.5% QD

EXPERIMENTAL

AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion Treatments will be randomly assigned to target lesions A and B.

Drug: AN2728 Topical Ointment, 2% QD; Drug: AN2728 Topical Ointment, 0.5% QD

AN2728 Topical Ointment, 2% BID vs 0.5% BID

EXPERIMENTAL

AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion. Treatments will be randomly assigned to target lesions A and B.

Drug: AN2728 Topical Ointment, 2% BID; Drug: AN2728 Topical Ointment, 0.5% BID

Interventions

AN2728 Topical Ointment, 2% QD DRUG

AN2728 Topical Ointment, 2% QD

AN2728 Topical Ointment, 2% QD vs 0.5% QD

AN2728 Topical Ointment, 0.5% QD DRUG

AN2728 Topical Ointment, 0.5% QD

AN2728 Topical Ointment, 2% QD vs 0.5% QD

AN2728 Topical Ointment, 2% BID DRUG

AN2728 Topical Ointment, 2% BID

AN2728 Topical Ointment, 2% BID vs 0.5% BID

AN2728 Topical Ointment, 0.5% BID DRUG

AN2728 Topical Ointment, 0.5% BID

AN2728 Topical Ointment, 2% BID vs 0.5% BID

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female 12 to 17 years of age, inclusive
• Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
• Total body surface area (BSA) of atopic dermatitis involvement ≤35%
• Presence of two comparable target lesions
• Willing and able to comply with study instructions and commit to attending all visits
• Females of childbearing potential must use a highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study.
• Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

You may not qualify if:

• Significant confounding conditions as assessed by study doctor
• Unstable or actively infected AD
• Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
• History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
• Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
• Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
• Current pregnancy or lactation, or intent to become pregnant during the study
• Known sensitivity to any of the components of the study drug
• Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
• Participated in a previous AN2728 clinical study

Sponsors & Collaborators

• Pfizer: lead

Study Sites (17)

Anacor Investigational Site

Fremont, California, United States

Location

Anacor Investigational Site

Miami, Florida, United States

Location

Anacor Investigational Site

Lousiville, Kentucky, United States

Location

Anacor Investigational Site

Detroit, Michigan, United States

Location

Anacor Investigational Site

Albuquerque, New Mexico, United States

Location

Anacor Investigational Site

Stony Brook, New York, United States

Location

Anacor Investigational Site

High Point, North Carolina, United States

Location

Anacor Investigational Site

Portland, Oregon, United States

Location

Anacor Investigational Site

Knoxville, Tennessee, United States

Location

Anacor Investigational Site

Salt Lake City, Utah, United States

Location

Anacor Investigational Site

Norfolk, Virginia, United States

Location

Anacor Investigational Site

Phillip, Australian Capital Territory, 2606, Australia

Location

Anacor Investigational Site

Kogarah, New South Wales, 2217, Australia

Location

Anacor Investigational Site

Wooloongabba, Queensland, Australia

Location

Anacor Investigational Site

Box Hill, Victoria, Australia

Location

Anacor Investigational Site

Parkville, Victoria, Australia

Location

Anacor Investigational Site

Fremantle, Western Australia, 6160, Australia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

BID protein, human

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

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

001-800-718-1021

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 21, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

AU (6); US (11)