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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: ATx201; Drug: ATx201 OINTMENT vehicle

• Registration Number: NCT04339985
• Lead Sponsor: UNION therapeutics

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.

Study Timeline

• Study Start: 2019-10-22
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-09
• Primary Completion: 2020-10-22
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATx201 OINTMENT 4%	ATx201	ATx201 OINTMENT 4%
ATx201 OINTMENT 7%	ATx201	ATx201 OINTMENT 7%
ATx201 OINTMENT vehicle	ATx201 OINTMENT vehicle	ATx201 OINTMENT vehicle

Primary Outcome Measures

Name	Time	Method
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)	Baseline to Week 6	EASI mean change from baseline at Week 6

Secondary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA) success	Baseline to Week 6	IGA success with defined improvement from baseline; success defined as clear (0) or almost clear (1) with ≥2 grade improvement from baseline
Mean change from baseline in Target lesion Total Sign Score (TSS)	Baseline to Week 6	Target lesion TSS mean change from baseline
change from baseline in Investigator Global Assessment (IGA) scoring	Baseline to Week 6	Distribution of IGA scores and change from baseline

Trial Locations

Locations (10)

UNION therapeutics Investigational Site 7; 🇵🇱 Nowy Targ, Poland

UNION therapeutics Investigational Site 10; 🇵🇱 Łódź, Poland

UNION therapeutics Investigational Site 5; 🇧🇬 Pleven, Bulgaria

UNION therapeutics Investigational Site 6; 🇵🇱 Bydgoszcz, Poland

UNION therapeutics Investigational Site 2; 🇧🇬 Sofia, Bulgaria

UNION therapeutics Investigational Site 3; 🇧🇬 Sofia, Bulgaria

UNION therapeutics Investigational Site 4; 🇧🇬 Sofia, Bulgaria

UNION therapeutics Investigational Site 9; 🇵🇱 Skierniewice, Poland

UNION therapeutics Investigational Site 1; 🇩🇰 Herlev, Denmark

UNION therapeutics Investigational Site 8; 🇵🇱 Wrocław, Poland