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

UNION Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: ATx201 OINTMENT vehicle; Drug: ATx201

Study type: Interventional

Funder types: Industry

Identifiers

NCT04339985

ATx201-207

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 3 patient groups

ATx201 OINTMENT 4%

Experimental group

Description:

ATx201 OINTMENT 4%

Treatment:

Drug: ATx201

ATx201 OINTMENT 7%

Experimental group

Description:

ATx201 OINTMENT 7%

Treatment:

Drug: ATx201

ATx201 OINTMENT vehicle

Experimental group

Description:

ATx201 OINTMENT vehicle

Treatment:

Drug: ATx201 OINTMENT vehicle