A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis

NCT03304470 | Completed Phase 2

• 1 other identifier: ATx201-003
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, 3-week, single-center, double-blind, randomized, two-arm, vehicle controlled study, with each individual receiving both active and vehicle treatment. Approximately 30 subjects with moderate atopic dermatitis will receive topically applied ATx201 CREAM 2% and matching vehicle once daily for 3 weeks (5 mg/cm2/day), without occlusion. ATx201 and vehicle will be applied on two separate target lesions of moderate atopic dermatitis (lesions of at least 3 × 3 cm, excluding the face, scalp, genitals, hands, and feet, ideally from the same anatomical location).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of local and systemic treatment-emergent adverse events

  \# of TEAEs

  34 days

Secondary Outcomes (3)

• Change from baseline in lesional Total Sign Score at Days 8, 15, and 22.

  22 Days

• Change from baseline in lesional Treatment Areas Assessment at Days 8, 15, and 22

  22 Days

• Change from baseline in skin barrier and biomarker levels at Day 22

  Day 22

Study Arms (2)

ATx201 2% CREAM

EXPERIMENTAL

Drug: ATx201 2% Cream

ATx201 Cream Vehicle

PLACEBO COMPARATOR

Drug: ATx201 Cream Vehicle

Interventions

ATx201 2% Cream DRUG

Anhydrous Cream

ATx201 2% CREAM

ATx201 Cream Vehicle DRUG

Anhydrous Cream

ATx201 Cream Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinically confirmed diagnosis of active atopic dermatitis
• at least a 6-month history of atopic dermatitis and had no significant flares in atopic dermatitis for at least 4 weeks before screening
• ≥2 areas of atopic dermatitis (excluding face, scalp, genitals, hands, and feet) of at least 3 × 3 cm; with a lesional TSS of ≥5 at Day 1 for each treatment area

You may not qualify if:

• breastfeeding, pregnant, or is planning to become pregnant during the study.
• clinically infected atopic dermatitis
• Fitzpatrick's Skin Phototype ≥5
• Presence of any tattoos, scratches, open sores, excessive hair, or skin damages in the target lesion areas
• known to have immune deficiency or is immunocompromised.
• history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
• major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
• clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
• known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
• used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
• used dupilumab within 12 weeks prior to Day 1.
• received any nonbiological investigational product or device within 4 weeks prior to Day 1
• used crisaborole and any other topical PDE-4 inhibitor within 4 weeks prior to Day 1.
• used doxepin within 1 week prior to Day 1.
• used topical products containing urea within 1 week prior to Day 1.

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (1)

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

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 Prokocimer

  Sponsor CMO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 9, 2017
• Study Start: September 25, 2017
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)