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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03304470
Recruitment Status : Completed
First Posted : October 9, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
UNION therapeutics

Tracking Information
First Submitted Date  ICMJE September 25, 2017
First Posted Date  ICMJE October 9, 2017
Last Update Posted Date March 20, 2018
Actual Study Start Date  ICMJE September 25, 2017
Actual Primary Completion Date March 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
Incidence of local and systemic treatment-emergent adverse events [ Time Frame: 34 days ]
# of TEAEs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: ATx201 2% Cream
    Anhydrous Cream
  • Drug: ATx201 Cream Vehicle
    Anhydrous Cream
Study Arms  ICMJE
  • Experimental: ATx201 2% CREAM
    Intervention: Drug: ATx201 2% Cream
  • Placebo Comparator: ATx201 Cream Vehicle
    Intervention: Drug: ATx201 Cream Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2018)
31
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2017)
30
Actual Study Completion Date  ICMJE March 5, 2018
Actual Primary Completion Date March 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03304470
Other Study ID Numbers  ICMJE ATx201-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party UNION therapeutics
Study Sponsor  ICMJE UNION therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Philippe Prokocimer Sponsor CMO
PRS Account UNION therapeutics
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP