Clinical trial NCT04339985: Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD
Official title: A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: UNION therapeutics
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 220
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned by using Interactive Web Response System (IWRS) to one of three treatment groups
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Investigator Global Assessment (IGA) success
timeFrame: Baseline to Week 6
measure: change from baseline in Investigator Global Assessment (IGA) scoring
timeFrame: Baseline to Week 6
measure: Mean change from baseline in Target lesion Total Sign Score (TSS)
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: UNION therapeutics Investigational Site 5
city: Sofia
country: Bulgaria
facility: UNION therapeutics Investigational Site 2
city: Sofia
country: Bulgaria
facility: UNION therapeutics Investigational Site 3
city: Sofia
country: Bulgaria
facility: UNION therapeutics Investigational Site 4
city: Herlev
country: Denmark
facility: UNION therapeutics Investigational Site 1
city: Bydgoszcz
country: Poland
facility: UNION therapeutics Investigational Site 6
city: Nowy Targ
country: Poland
facility: UNION therapeutics Investigational Site 7
city: Skierniewice
country: Poland
facility: UNION therapeutics Investigational Site 9
city: Wrocław
country: Poland
facility: UNION therapeutics Investigational Site 8
city: Łódź
country: Poland
facility: UNION therapeutics Investigational Site 10
Study officials:
affiliation: UNION therapeutics
name: Philippe Andres, Dr.
role: STUDY_CHAIR
References: