Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Anacor Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02118792
First received: April 15, 2014
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: AN2728 Topical Ointment, 2%
Drug: Matching vehicle control
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Primary Efficacy Endpoint: Proportion of subjects achieving success in ISGA at Day 29 in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Through 36 days ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Time to success in ISGA in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Through 29 days ] [ Designated as safety issue: No ]
  • Change from baseline in signs of AD in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Time to improvement in pruritus in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Through 29 days ] [ Designated as safety issue: No ]
  • Dermatology related QoL scores in the AN2728 treated group compared to the vehicle treated group [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: March 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AN2728 Topical Ointment, 2%
AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days
Drug: AN2728 Topical Ointment, 2%
Placebo Comparator: Matching vehicle control
Matching vehicle control, applied twice daily for up to 28 days
Drug: Matching vehicle control

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 and male subjects with female partners 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118792

Contacts
Contact: Robin Blumenthal, PhD 650-223-8597 clinicaltrials@anacor.com

Locations
United States, Virginia
Anacor Investigational Site Recruiting
Henrico, Virginia, United States
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Chair: Xiaoming Lin, RN, BSN, MS Anacor Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02118792     History of Changes
Other Study ID Numbers: AN2728-AD-302
Study First Received: April 15, 2014
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Anacor Pharmaceuticals, Inc.:
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 27, 2014