This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234 in two populations: healthy volunteers and participants with moderate to severe atopic dermatitis (AD). Healthy volunteers will participate in Single Ascending Dose (SAD) Cohorts 1-5. Participants with moderate to severe AD will be enrolled in SAD Cohorts 6-7, Multiple Ascending Dose (MAD) Cohorts, and a Proof-of-Concept (POC) expansion cohort.
The study consists of 3 parts with staggered initiation: * Part A - Phase 1a SAD: ARQ-234 will be assessed in single ascending dose cohorts in healthy volunteer participants and participants with atopic dermatitis. * Part B - Phase 1b MAD: ARQ-234 will be assessed in multiple ascending cohorts in participants with atopic dermatitis. * Part C - Phase 1b POC Expansion: ARQ-234 will be assessed in participants with atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Clinical Site 106
Plainfield, Indiana, United States
RECRUITINGClinical Site 101
Fair Lawn, New Jersey, United States
RECRUITINGClinical Site 102
College Station, Texas, United States
RECRUITINGClinical Site 104
San Antonio, Texas, United States
RECRUITINGClinical Site 109
South Jordan, Utah, United States
RECRUITINGNumber and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)
Time frame: From screening to the last follow up visit for each study part (Part A: 16 weeks, Part B: 30 weeks, Part C: 30 weeks)
Percent change from Baseline in the Eczema Area and Severity Index (EASI) score, a validated measure of disease severity in atopic dermatitis.
Time frame: From Baseline to Week 16
Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile
Time frame: From Baseline to Week 16
Percentage of participants achieving at least a 50% improvement from baseline in EASI total score (EASI-50)
Time frame: From Baseline to Week 16
Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75)
Time frame: From Baseline to Week 16
Absolute change and percent change from baseline in the percentage of body surface area affected by atopic dermatitis
Time frame: From Baseline to Week 16
Absolute change and percent change from baseline in itch severity as measured by the Itch Numeric Rating Scale
Time frame: From Baseline to Week 16
Absolute change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score
Time frame: From Baseline to Week 16
Percentage of participants achieving at least a 50% improvement from baseline in SCORAD total score
Time frame: From Baseline to Week 16
Percentage of participants achieving at least a 75% improvement from baseline in SCORAD score
Time frame: From Baseline to Week 16
Absolute change and percent change from baseline in Patient-Oriented Eczema Measure (POEM) score
Time frame: From Baseline to Week 16
Percentage of participants achieving a Validated Investigator's Global Assessment (vIGA-AD) score of 0 (Clear) or 1 (Almost Clear) with at least a 2-grade improvement from baseline
Time frame: From Baseline to Week 16
Percentage of participants with a vIGA-AD score of 0 (Clear)
Time frame: From Baseline to Week 16
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