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Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ATx201
ATx201 OINTMENT vehicle
Sponsored by
UNION therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (main ones):

  1. Diagnosis of AD using the Hanifin and Rajka criteria and minimum 1-year history with a current IGA score of 2 or 3 and treatable BSA ≥5% but ≤36% (treatable BSA includes all lesions present at screening except scalp)
  2. Age ≥12 and <60 years
  3. Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Day 1.
  4. Subject or LAR able to understand and provide signed informed consent. Assent is also required of adolescents.
  5. Normally active and otherwise in good health by medical history and physical examination

Exclusion Criteria (main ones):

  1. Actively infected AD (ie, requiring antimicrobial therapy as determined by the investigator)
  2. Acute exacerbation or flare in the 4 weeks prior to the Day 1 visit that necessitates treatment with a high potency corticosteroid (such as clobetasol propionate or betamethasone dipropionate), or antibiotics, or prednisolone
  3. Enrollment in an ATx201 study in the previous 6 months
  4. Allergy or history of significant adverse reaction to ATx201 or related compounds, or to any of the excipients used
  5. Underlying skin condition that may interfere with the placement of study treatment or impede clinical evaluations (including active Herpes simplex)
  6. Current acute or chronic condition unless considered clinically irrelevant and stable by the investigator
  7. The presence of a condition the investigator believes would interfere with the ability to provide informed consent or assent, or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk
  8. Unable or unwilling to comply with study procedures
  9. Exposure to any IP within 30 days prior to randomization

There are also some specific criteria related to prior or concomitant therapy

Sites / Locations

  • UNION therapeutics Investigational Site 5
  • UNION therapeutics Investigational Site 2
  • UNION therapeutics Investigational Site 3
  • UNION therapeutics Investigational Site 4
  • UNION therapeutics Investigational Site 1
  • UNION therapeutics Investigational Site 6
  • UNION therapeutics Investigational Site 7
  • UNION therapeutics Investigational Site 9
  • UNION therapeutics Investigational Site 8
  • UNION therapeutics Investigational Site 10

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ATx201 OINTMENT 4%

ATx201 OINTMENT 7%

ATx201 OINTMENT vehicle

Arm Description

ATx201 OINTMENT 4%

ATx201 OINTMENT 7%

ATx201 OINTMENT vehicle

Outcomes

Primary Outcome Measures

Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
EASI mean change from baseline at Week 6

Secondary Outcome Measures

Investigator Global Assessment (IGA) success
IGA success with defined improvement from baseline; success defined as clear (0) or almost clear (1) with ≥2 grade improvement from baseline
change from baseline in Investigator Global Assessment (IGA) scoring
Distribution of IGA scores and change from baseline
Mean change from baseline in Target lesion Total Sign Score (TSS)
Target lesion TSS mean change from baseline

Full Information

First Posted
March 23, 2020
Last Updated
April 28, 2021
Sponsor
UNION therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04339985
Brief Title
Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD
Official Title
A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
October 22, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNION therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis
Detailed Description
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis. Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201 OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive blocks in 1:1:1 ratio for the active groups and vehicle. Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly assigned by using Interactive Web Response System (IWRS) to one of three treatment groups
Masking
ParticipantInvestigator
Masking Description
Approx. 210 subjects randomized and 16 subjects will be in an open-label sub-study
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATx201 OINTMENT 4%
Arm Type
Experimental
Arm Description
ATx201 OINTMENT 4%
Arm Title
ATx201 OINTMENT 7%
Arm Type
Experimental
Arm Description
ATx201 OINTMENT 7%
Arm Title
ATx201 OINTMENT vehicle
Arm Type
Experimental
Arm Description
ATx201 OINTMENT vehicle
Intervention Type
Drug
Intervention Name(s)
ATx201
Other Intervention Name(s)
ATx201 OINTMENT
Intervention Description
Topical
Intervention Type
Drug
Intervention Name(s)
ATx201 OINTMENT vehicle
Intervention Description
ATx201 OINTMENT vehicle
Primary Outcome Measure Information:
Title
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
Description
EASI mean change from baseline at Week 6
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Investigator Global Assessment (IGA) success
Description
IGA success with defined improvement from baseline; success defined as clear (0) or almost clear (1) with ≥2 grade improvement from baseline
Time Frame
Baseline to Week 6
Title
change from baseline in Investigator Global Assessment (IGA) scoring
Description
Distribution of IGA scores and change from baseline
Time Frame
Baseline to Week 6
Title
Mean change from baseline in Target lesion Total Sign Score (TSS)
Description
Target lesion TSS mean change from baseline
Time Frame
Baseline to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (main ones): Diagnosis of AD using the Hanifin and Rajka criteria and minimum 1-year history with a current IGA score of 2 or 3 and treatable BSA ≥5% but ≤36% (treatable BSA includes all lesions present at screening except scalp) Age ≥12 and <60 years Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Day 1. Subject or LAR able to understand and provide signed informed consent. Assent is also required of adolescents. Normally active and otherwise in good health by medical history and physical examination Exclusion Criteria (main ones): Actively infected AD (ie, requiring antimicrobial therapy as determined by the investigator) Acute exacerbation or flare in the 4 weeks prior to the Day 1 visit that necessitates treatment with a high potency corticosteroid (such as clobetasol propionate or betamethasone dipropionate), or antibiotics, or prednisolone Enrollment in an ATx201 study in the previous 6 months Allergy or history of significant adverse reaction to ATx201 or related compounds, or to any of the excipients used Underlying skin condition that may interfere with the placement of study treatment or impede clinical evaluations (including active Herpes simplex) Current acute or chronic condition unless considered clinically irrelevant and stable by the investigator The presence of a condition the investigator believes would interfere with the ability to provide informed consent or assent, or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk Unable or unwilling to comply with study procedures Exposure to any IP within 30 days prior to randomization There are also some specific criteria related to prior or concomitant therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Andres, Dr.
Organizational Affiliation
UNION therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
UNION therapeutics Investigational Site 5
City
Pleven
Country
Bulgaria
Facility Name
UNION therapeutics Investigational Site 2
City
Sofia
Country
Bulgaria
Facility Name
UNION therapeutics Investigational Site 3
City
Sofia
Country
Bulgaria
Facility Name
UNION therapeutics Investigational Site 4
City
Sofia
Country
Bulgaria
Facility Name
UNION therapeutics Investigational Site 1
City
Herlev
Country
Denmark
Facility Name
UNION therapeutics Investigational Site 6
City
Bydgoszcz
Country
Poland
Facility Name
UNION therapeutics Investigational Site 7
City
Nowy Targ
Country
Poland
Facility Name
UNION therapeutics Investigational Site 9
City
Skierniewice
Country
Poland
Facility Name
UNION therapeutics Investigational Site 8
City
Wrocław
Country
Poland
Facility Name
UNION therapeutics Investigational Site 10
City
Łódź
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD

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