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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-22

Study Completion Date

2021-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Approx. 210 subjects randomized and 16 subjects will be in an open-label sub-study

Study Groups

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ATx201 OINTMENT 4%

Group Type EXPERIMENTAL

ATx201

Intervention Type DRUG

Topical

ATx201 OINTMENT 7%

Group Type EXPERIMENTAL

ATx201

Intervention Type DRUG

Topical

ATx201 OINTMENT vehicle

Group Type EXPERIMENTAL

ATx201 OINTMENT vehicle

Intervention Type DRUG

ATx201 OINTMENT vehicle

Interventions

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ATx201

Topical

Intervention Type DRUG

ATx201 OINTMENT vehicle

Intervention Type DRUG

Other Intervention Names

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ATx201 OINTMENT

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No