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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339985
• Other study ID #: ATx201-207
• Status: Completed
• Phase: Phase 2
• Start date: October 22, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: UNION therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 31, 2021
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ATx201
Topical
• ATx201 OINTMENT vehicle
ATx201 OINTMENT vehicle

Locations

Country	Name	City	State
Bulgaria	UNION therapeutics Investigational Site 5	Pleven
Bulgaria	UNION therapeutics Investigational Site 2	Sofia
Bulgaria	UNION therapeutics Investigational Site 3	Sofia
Bulgaria	UNION therapeutics Investigational Site 4	Sofia
Denmark	UNION therapeutics Investigational Site 1	Herlev
Poland	UNION therapeutics Investigational Site 6	Bydgoszcz
Poland	UNION therapeutics Investigational Site 10	Lódz
Poland	UNION therapeutics Investigational Site 7	Nowy Targ
Poland	UNION therapeutics Investigational Site 9	Skierniewice
Poland	UNION therapeutics Investigational Site 8	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
UNION therapeutics

Countries where clinical trial is conducted

Bulgaria,  Denmark,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	change from baseline in Investigator Global Assessment (IGA) scoring	Distribution of IGA scores and change from baseline	Baseline to Week 6
Secondary	Mean change from baseline in Target lesion Total Sign Score (TSS)	Target lesion TSS mean change from baseline	Baseline to Week 6