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

NCT04339985 | Completed Phase 2

• 1 other identifier: ATx201-207
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 10

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Investigator Global Assessment (IGA) success

  Baseline to Week 6

• change from baseline in Investigator Global Assessment (IGA) scoring

  Baseline to Week 6

• Mean change from baseline in Target lesion Total Sign Score (TSS)

  Baseline to Week 6

Study Arms (3)

ATx201 OINTMENT 4%

EXPERIMENTAL

ATx201 OINTMENT 4%

Drug: ATx201

ATx201 OINTMENT 7%

EXPERIMENTAL

ATx201 OINTMENT 7%

Drug: ATx201

ATx201 OINTMENT vehicle

EXPERIMENTAL

ATx201 OINTMENT vehicle

Drug: ATx201 OINTMENT vehicle

Interventions

ATx201 DRUG

Topical

Also known as: ATx201 OINTMENT

ATx201 OINTMENT 4%; ATx201 OINTMENT 7%

ATx201 OINTMENT vehicle DRUG

ATx201 OINTMENT vehicle

ATx201 OINTMENT vehicle

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (10)

UNION therapeutics Investigational Site 5

Pleven, Bulgaria

Location

UNION therapeutics Investigational Site 2

Sofia, Bulgaria

Location

UNION therapeutics Investigational Site 3

Sofia, Bulgaria

Location

UNION therapeutics Investigational Site 4

Sofia, Bulgaria

Location

UNION therapeutics Investigational Site 1

Herlev, Denmark

Location

UNION therapeutics Investigational Site 6

Bydgoszcz, Poland

Location

UNION therapeutics Investigational Site 10

Lodz, Poland

Location

UNION therapeutics Investigational Site 7

Nowy Targ, Poland

Location

UNION therapeutics Investigational Site 9

Skierniewice, Poland

Location

UNION therapeutics Investigational Site 8

Wroclaw, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Philippe Andres, Dr.

  UNION therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Approx. 210 subjects randomized and 16 subjects will be in an open-label sub-study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly assigned by using Interactive Web Response System (IWRS) to one of three treatment groups

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 9, 2020
• Study Start: October 22, 2019
• Primary Completion: October 22, 2020
• Study Completion: March 31, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5); DK (1); BU (4)