A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis

A Double-Blind, Randomized, Intraindividual, Vehicle-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Topically Applied ATx201 in Subjects With Moderate Atopic Dermatitis

This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle controlled study, with each individual receiving both active and vehicle treatment. Approximately 30 subjects with moderate atopic dermatitis will receive topically applied ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands, and feet, ideally from the same anatomical location).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: ATx201 2% Cream; Drug: ATx201 Cream Vehicle

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2K 4L5
      • Innovaderm Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• clinically confirmed diagnosis of active atopic dermatitis
• at least a 6-month history of atopic dermatitis and had no significant flares in atopic dermatitis for at least 4 weeks before screening
• ≥2 areas of atopic dermatitis (excluding face, scalp, genitals, hands, and feet) of at least 3 × 3 cm; with a lesional TSS of ≥5 at Day 1 for each treatment area

Exclusion Criteria:

• breastfeeding, pregnant, or is planning to become pregnant during the study.
• clinically infected atopic dermatitis
• Fitzpatrick's Skin Phototype ≥5
• Presence of any tattoos, scratches, open sores, excessive hair, or skin damages in the target lesion areas
• known to have immune deficiency or is immunocompromised.
• history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
• major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
• clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
• known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
• used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
• used dupilumab within 12 weeks prior to Day 1.
• received any nonbiological investigational product or device within 4 weeks prior to Day 1
• used crisaborole and any other topical PDE-4 inhibitor within 4 weeks prior to Day 1.
• used doxepin within 1 week prior to Day 1.
• used topical products containing urea within 1 week prior to Day 1.
• used nonurea-containing emollient anywhere on the body from 1 day before Day 1.
• used systemic antibiotics or topical antibiotics on the treated areas within 2 weeks prior to Day 1.
• used any topical medicated treatment for atopic dermatitis within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials, medical devices, and bleach baths.
• used systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Day 1 (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids).
• received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
• excessive sun exposure, is planning a trip to a sunny climate, has received ultraviolet phototherapy, or has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products (excluding the treatment areas) and protective apparel are recommended when exposure cannot be avoided.
• known or suspected allergy to ATx201 or any component of the investigational product.
• known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
• history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
• history of hypertrophic scarring or keloid formation in scars or suture sites.
• taking anticoagulant medication, such as heparin, low molecular weight-heparin, warfarin, or antiplatelets (nonsteroidal anti-inflammatory drugs and aspirin ≤81 mg will not be considered antiplatelets) within 2 weeks prior to Day 1, or has a contraindication to skin biopsies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATx201 2% CREAM	Drug: ATx201 2% Cream; Anhydrous Cream
Placebo Comparator: ATx201 Cream Vehicle	Drug: ATx201 Cream Vehicle; Anhydrous Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of local and systemic treatment-emergent adverse events	# of TEAEs	34 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in lesional Total Sign Score at Days 8, 15, and 22.	22 Days
Change from baseline in lesional Treatment Areas Assessment at Days 8, 15, and 22	22 Days
Change from baseline in skin barrier and biomarker levels at Day 22	Day 22

Collaborators and Investigators

• Sponsor: UNION therapeutics
• Investigators: Study Director: Philippe Prokocimer, Sponsor CMO

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): March 5, 2018
• Study Completion (Actual): March 5, 2018

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ATx201-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No