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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 5, 2018

Interventions

  • Drug: ATx201 2% Cream
    • Anhydrous Cream
  • Drug: ATx201 Cream Vehicle
    • Anhydrous Cream

Arms, Groups and Cohorts

  • Experimental: ATx201 2% CREAM
  • Placebo Comparator: ATx201 Cream Vehicle

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of local and systemic treatment-emergent adverse events
    • Time Frame: 34 days
    • # of TEAEs

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AntibioTx A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philippe Prokocimer, Study Director, Sponsor CMO

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