A Multicenter, Randomized, Double-Blind, Bilateral, Vehicle-Controlled Study of the Safety and Efficacy of ALX-101 Topical Gel Administered Twice Daily in Adult and Adolescent Subjects With Moderate Atopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- ALX-101 Gel 1.5% and ALX-101 Gel Vehicle
- Conditions
- Atopic Dermatitis
- Sponsor
- Ralexar Therapeutics, Inc.
- Enrollment
- 209
- Locations
- 35
- Primary Endpoint
- Physician's Global Assessment (PGA)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of ALX-101 Gel 1.5% and 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 42 days to adult and adolescent subjects with moderate atopic dermatitis.
Detailed Description
The main objectives of this study are to: * Evaluate the safety and tolerability of ALX-101 Gel 1.5% and 5% when applied topically in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle * Evaluate the dose-response relationship of ALX-101 Gel 1.5% and 5% when applied topically twice daily in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible for the study, subjects must fulfill all of the following criteria:
- •Subject is at least 12 years of age
- •Subject has a clinical diagnosis of stable AD characterized by:
- •Eczema (acute, subacute, chronic)
- •Typical morphology and distribution with age-specific patterns
- •Chronic or relapsing history
- •Subject must have active AD covering 4-24% body surface area (BSA) (right and left treatment areas combined)
- •Bilateral treatment areas of AD must be 5 cm apart
- •Presence of AD with comparable bilateral target evaluation areas on (right and left sides of body) and within each bilateral treatment area:
- •a. Bilateral target evaluation areas must each have active AD covering 0.5 -2% body surface area (BSA)
Exclusion Criteria
- •Any subject who meets one or more of the following criteria will not be included in this study:
- •Subject has spontaneously improving or rapidly deteriorating AD
- •Subject has clinically infected AD
- •Subject has any signs or symptoms associated with topical AD therapy (e.g., history of anaphylaxis, hypersensitivity reactions, skin atrophy, striae, pigmentary changes) which, in the investigator's opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation
- •Subject has used any systemic immunosuppressive or immunomodulatory therapy (e.g., etanercept, alefacept, infliximab) within 16 weeks prior to Visit 1
- •Subject has used any phototherapy (e.g., ultraviolet A, ultraviolet B) which, in the investigator's opinion, might affect AD within 4 weeks prior to Visit 1
- •Subject has used any systemic therapy (e.g., systemic corticosteroids \[intranasal and inhaled corticosteroids are allowed\]), prednisone cyclosporine, immunosuppressants/immunomodulators, Janus Kinase (JAK) inhibitors, methotrexate, cytostatics) within 4 weeks prior to Visit 1 which, in the investigator's opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation
- •Subject has used any systemic antibiotics within 2 weeks prior to Visit 1
- •Subject has used any topical AD therapy (e.g., corticosteroids, calcineurin inhibitors, topical H1 and H2 antihistamines, topical antimicrobials, and other medicated topical agents) on the planned treatment area(s) within one week prior to Visit 1
- •Subject has used emollients/moisturizers on the planned treatment area(s) within 4 hours prior to Visit 1
Arms & Interventions
ALX-101 Gel 1.5% vs. ALX-101 Gel Vehicle
ALX-101 Gel 1.5% applied twice daily for 42 days to one treatment area and ALX-101 Gel Vehicle applied twice daily for 42 days to a second treatment area. Treatments will be randomly assigned to bilateral target areas.
Intervention: ALX-101 Gel 1.5% and ALX-101 Gel Vehicle
ALX-101 Gel 5% vs. ALX-101 Gel Vehicle
ALX-101 Gel 5% applied twice daily for 42 days to one treatment area and ALX-101 Gel Vehicle applied twice daily for 42 days to a second treatment area. Treatments will be randomly assigned to bilateral target areas.
Intervention: ALX-101 Gel 5% and ALX-101 Gel Vehicle
Outcomes
Primary Outcomes
Physician's Global Assessment (PGA)
Time Frame: Day 42
The primary effectiveness analysis will be based on mean change in PGA score from baseline (Visit 2) to Visit 6.