Safety, Pharmacokinetics and Efficacy of FMX114 Versus Vehicle in Adults With Atopic Dermatitis

NCT04927572 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VY2021-01
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 7

Brief Summary

A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial with Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Mean Change from Baseline in Atopic Dermatitis Severity Index (ADSI) score at Day 29

  Day 29

• Incidence, type and severity of adverse events (AEs) at Day 43

  Day 43

Study Arms (2)

FMX114

EXPERIMENTAL

Drug: FMX114

Vehicle

PLACEBO COMPARATOR

Other: Vehicle

Interventions

FMX114 DRUG

Active Comparator

FMX114

Vehicle OTHER

Placebo Comparator

Vehicle

Eligibility Criteria

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

You may qualify if:

• Subjects must have the ability to understand and be willing to sign an informed consent form.
• Aged ≥ 18 years, at time of screening visit.
• Weight ≥ 40 kg, at time of screening visit.
• Diagnosis of Atopic Dermatitix with a total body surface area (BSA) of AD involvement of ≤ 35% excluding involvement of face, scalp and groin at screening and Day 1, prior to first dose.
• Atopic dermatitis should be present for at least 3 months with stable disease for ≥ 1 month at the time of the screening visit and on Day 1, prior to dose administration.
• Have the presence of at least 2 comparable target AD lesions (size approximately 10 to 200 cm2), located on the trunk, upper extremities or lower extremities. In addition, the 2 target lesions:
• must have ADSI score of ≥ 6 and ≤ 12 AND a between-lesion difference in ADSI of ≤ 1.
• must be separated by ≥ 10 cm.
• Positive varicella zoster virus (VZV) antibody test at the screening visit. At the discretion of the Investigator, subjects who return a negative result may be re-screened following a full VZV vaccination course.
• Medically healthy in the opinion of the Investigator without significant abnormalities at the screening visit and prior to dose administration on Day 1, including:
• Physical examination without any clinically relevant findings (excluding findings relating to AD).
• Systolic blood pressure in the range of 90 to 160 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position.
• Heart rate in the range of 45 to 100 bpm (inclusive) after 5 minutes rest in supine.
• Body temperature (tympanic or oral), between 35.5°C and 37.7°C (inclusive).
• Electrocardiogram findings (ventricular HR, PR interval, QRS duration, QT interval and QTcF) within normal ranges (site-specific normal ranges may be used).

You may not qualify if:

• In the opinion of the Investigator, subject has unstable or actively infected AD at the screening visit, or prior to dose administration on Day 1.
• Active impetigo at any of the target lesions.
• Concomitant dermatologic conditions (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may, in the opinion of the Investigator, interfere with evaluations of the subject's response to study drug.
• Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
• Evidence or history of active, latent or inadequately treated tuberculosis (TB) infection at the screening visit.
• Evidence or history of disseminated or recurrent herpes zoster infection.
• Clinically significant active infection (in the opinion of the Investigator) within 2 weeks prior to first dose application on Day 1.
• Any known or suspected premalignant or malignant disease within the last 5 years (excluding successfully treated basal cell carcinomas).
• Have received AD-directed therapy within the following timeframes prior to dose administration on Day 1:
• Ultraviolet A (UVA) or Ultraviolet B (UVB) therapy within 2 weeks.
• Systemic or topical corticosteroids within the past 2 weeks.
• Other topical anti-inflammatory therapy e.g. Janus kinase (JAK) inhibitors, calcineurin inhibitors, Phosphodiesterase-4 inhibitors within the past 2 weeks.
• Systemic JAK inhibitors within the past 12 weeks.
• Systemic biologic therapy within the past 12 weeks.
• Bleach or other antiseptic baths (e.g., potassium permanganate) within the past 2 weeks.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (7)

Investigator #9

Miami, Florida, 33173, United States

Location

Investigator #14

Miami, Florida, 33175, United States

Location

Investigator #12

Miramar, Florida, 33027, United States

Location

Investigator #13

Sugarloaf, Pennsylvania, 18249, United States

Location

Investigator #5

Phillip, Australian Capital Territory, 2606, Australia

Location

Investigator #6

Darlinghurst, New South Wales, 2010, Australia

Location

Investigational Site #1

Adelaide, South Australia, 5000, Australia

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 16, 2021
• Study Start: October 13, 2021
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); AU (3)