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

Dermatitis, Atopic Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118792
• Other study ID #: AN2728-AD-302
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2014
• Last updated: August 10, 2016
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: August 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 764
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AN2728 Topical Ointment, 2%

• Matching vehicle control

Locations

Country	Name	City	State
United States	Anacor Investigational Site	Henrico	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to improvement in pruritus in the AN2728 treated group compared to the vehicle treated group		Through 29 days	No
Other	Dermatology related QoL scores in the AN2728 treated group compared to the vehicle treated group		Day 29	No
Primary	Primary Efficacy Endpoint: Proportion of subjects achieving success in ISGA at Day 29 in the AN2728 treated group compared to the vehicle treated group		Day 29	No
Secondary	Primary Safety Endpoint: Frequency of TEAEs, SAEs, and clinically significant changes in vital signs and clinical laboratory parameters in the AN2728 treated group compared to the vehicle treated group		Through 36 days	Yes
Secondary	Proportion of subjects with an ISGA score of Clear (0) or Almost Clear (1) at Day 29 in the AN2728 treated group compared to the vehicle treated group		Day 29	No
Secondary	Time to success in ISGA in the AN2728 treated group compared to the vehicle treated group		Through 29 days	No
Secondary	Change from baseline in signs of AD in the AN2728 treated group compared to the vehicle treated group		Day 29	No