A Study in Subjects With Moderate Atopic Dermatitis

NCT03175354 | Completed Phase 2 FDA Drug

• 1 other identifier: ALX-101-ATOP-202
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 35

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.

Conditions

Atopic Dermatitis; Eczema, Atopic

Outcome Measures

Primary Outcomes (1)

• Physician's Global Assessment (PGA)

  The primary effectiveness analysis will be based on mean change in PGA score from baseline (Visit 2) to Visit 6.

  Day 42

Study Arms (2)

ALX-101 Gel 1.5% vs. ALX-101 Gel Vehicle

EXPERIMENTAL

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.

Drug: ALX-101 Gel 1.5% and ALX-101 Gel Vehicle

ALX-101 Gel 5% vs. ALX-101 Gel Vehicle

EXPERIMENTAL

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.

Drug: ALX-101 Gel 5% and ALX-101 Gel Vehicle

Interventions

ALX-101 Gel 1.5% and ALX-101 Gel Vehicle DRUG

Bilateral application of ALX-101 Gel 1.5% and ALX-101 Gel Vehicle

ALX-101 Gel 1.5% vs. ALX-101 Gel Vehicle

ALX-101 Gel 5% and ALX-101 Gel Vehicle DRUG

Bilateral application of ALX-101 Gel 5% and ALX-101 Gel Vehicle

ALX-101 Gel 5% vs. ALX-101 Gel Vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Pruritus
• 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)
• Bilateral target evaluation areas of AD must each have a Physician's Global Assessment score of 3 ("moderate") to be treated
• Subject Visit 1 photographs are approved for enrollment by dermatology assessor
• If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
• Subject is non-pregnant and non-lactating

You may not qualify if:

• 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
• Subject is currently using H1 antihistamines (e.g., diphenhydramine, terfenadine) UNLESS a stable dose has been used for at least 14 days prior to Visit 1
• Subject has a history of sensitivity to any of the ingredients in the study medications
• Subject has any known concomitant dermatologic or medical condition which, in the investigator's opinion, might impair evaluation of the bilateral treatment and/or target evaluation areas of AD being treated or which exposes the subject to an unacceptable risk by study participation (e.g., psoriasis, lichen planus, lichen simplex chronicus,…)
• Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

Sponsors & Collaborators

• Ralexar Therapeutics, Inc.: lead

Study Sites (35)

Ralexar Investigational Site 35

Anniston, Alabama, 36207, United States

Location

Ralexar Investigational Site 21

Birmingham, Alabama, 35209, United States

Location

Ralexar Investigational Site 18

Laguna Hills, California, 92653, United States

Location

Ralexar Investigational Site 23

Los Angeles, California, 90045, United States

Location

Ralexar Investigational Site 24

Oceanside, California, 92056, United States

Location

Ralexar Investigational Site 34

San Diego, California, 92103, United States

Location

Ralexar Investigational Site 16

San Diego, California, 92108, United States

Location

Ralexar Investigational Site 33

San Diego, California, 92121, United States

Location

Ralexar Investigational Site 27

Santa Monica, California, 90404, United States

Location

Ralexar Investigational Site 1

Miami, Florida, 33143, United States

Location

Ralexar Investigational Site 14

Pinellas Park, Florida, 33781, United States

Location

Ralexar Investigational Site 22

Tampa, Florida, 33618, United States

Location

Ralexar Investigational Site 29

Snellville, Georgia, 30078, United States

Location

Ralexar Investigational Site 17

New Albany, Indiana, 47150, United States

Location

Ralexar Investigational Site 32

Louisville, Kentucky, 40202, United States

Location

Ralexar Investigational Site 7

Louisville, Kentucky, 40241, United States

Location

Ralexar Investigational Site 11

Warren, Michigan, 48088, United States

Location

Ralexar Investigational Site 15

Fridley, Minnesota, 55432, United States

Location

Ralexar Investigational Site 25

Saint Joseph, Missouri, 64506, United States

Location

Ralexar Investigational Site 26

Albuquerque, New Mexico, 87106, United States

Location

Ralexar Investigational Site 20

New York, New York, 10075, United States

Location

Ralexar Investigational Site 30

Stony Brook, New York, 11790, United States

Location

Ralexar Investigational Site 28

Charlotte, North Carolina, 28217, United States

Location

Ralexar Investigational Site 12

Beachwood, Ohio, 44122, United States

Location

Ralexar Investigational Site 5

Cincinnati, Ohio, 45236, United States

Location

Ralexar Investigational Site 3

Oklahoma City, Oklahoma, 73112, United States

Location

Ralexar Investigational Site 8

Johnston, Rhode Island, 02919, United States

Location

Ralexar Investigational Site 6

Spartanburg, South Carolina, 29303, United States

Location

Ralexar Investigational Site 9

Nashville, Tennessee, 37215, United States

Location

Ralexar Investigational Site 19

Austin, Texas, 78745, United States

Location

Ralexar Investigational Site 31

Austin, Texas, 78759, United States

Location

Ralexar Investigational Site 4

Plano, Texas, 75024, United States

Location

Ralexar Investigational Site 2

San Antonio, Texas, 78218, United States

Location

Ralexar Investigational Site 13

Richmond, Virginia, 23220, United States

Location

Ralexar Investigational Site 10

Spokane, Washington, 99202, United States

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 Design

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

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: April 26, 2017
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

US (35)