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

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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: ATx201; Drug: ATx201 OINTMENT vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria
    • UNION therapeutics Investigational Site 5
  • Sofia, Bulgaria
    • UNION therapeutics Investigational Site 2
  • Sofia, Bulgaria
    • UNION therapeutics Investigational Site 3
  • Sofia, Bulgaria
    • UNION therapeutics Investigational Site 4
• Denmark
  • Herlev, Denmark
    • UNION therapeutics Investigational Site 1
• Poland
  • Bydgoszcz, Poland
    • UNION therapeutics Investigational Site 6
  • Nowy Targ, Poland
    • UNION therapeutics Investigational Site 7
  • Skierniewice, Poland
    • UNION therapeutics Investigational Site 9
  • Wrocław, Poland
    • UNION therapeutics Investigational Site 8
  • Łódź, Poland
    • UNION therapeutics Investigational Site 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATx201 OINTMENT 4%	Drug: ATx201; Topical; Other Names: ATx201 OINTMENT
Experimental: ATx201 OINTMENT 7%	Drug: ATx201; Topical; Other Names: ATx201 OINTMENT
Experimental: ATx201 OINTMENT vehicle	Drug: ATx201 OINTMENT vehicle; ATx201 OINTMENT vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)	EASI mean change from baseline at Week 6	Baseline to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to Week 6
change from baseline in Investigator Global Assessment (IGA) scoring	Distribution of IGA scores and change from baseline	Baseline to Week 6
Mean change from baseline in Target lesion Total Sign Score (TSS)	Target lesion TSS mean change from baseline	Baseline to Week 6

Collaborators and Investigators

• Sponsor: UNION therapeutics
• Investigators: Study Chair: Philippe Andres, Dr., UNION therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): October 22, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

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: ATx201-207

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