Atopic Dermatitis (AD), Eczema
Conditions
Keywords
ARQ-234
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALARQ-234
ARQ-234 subcutaneous injectable solution
DRUGPlacebo
Placebo subcutaneous injectable solution
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
(All Participants): * Able and willing to provide written informed consent. * Adults 18-65 years (inclusive) at consent. * Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator). * Contraception requirements: Females of childbearing potential: negative pregnancy tests at screening and baseline and agree to use highly effective contraception (plus barrier method) during the study and for 4 months after last dose. Males if sexually active with a pregnant partner or a female of childbearing potential, agree to condom use during the study and for 4 months after last dose. * Body weight by study part: Part A (SAD) \& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive) Inclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C): * Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening. * Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-AD 3-4, EASI ≥16 at Baseline. * Inadequate response, intolerance, or medical inappropriateness of topical AD therapies (and/or prior systemic AD therapy failure within the last year may qualify as inadequate response).
Exclusion criteria
(All Participants): * Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator). * Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions). * Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol). * History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics). * History of attempted suicide or significant current risk, per investigator). * Chronic or significant infection history or positive screening tests for hepatitis B, hepatitis C, HIV, or tuberculosis (including positive QuantiFERON or history of active/latent TB). * Known/suspected immunosuppression or history of invasive opportunistic infections or unusually frequent/recurrent/prolonged infections (per investigator). * Recent herpes zoster that poses risk or may affect interpretation (per investigator). * Malignancy within 5 years prior to screening * Positive urine drug screen at screening (Part A/Part B only) or drug/alcohol abuse within 12 months, or other condition likely to impair compliance (per investigator). * Unable to discontinue prohibited medications/treatments per protocol. * Major surgery within 4 weeks prior to baseline or planned during participation. * Participation in another trial or receipt of investigational product within 12 weeks (or 5 half-lives, whichever longer) before baseline. * Prior cell-depleting therapy (e.g., rituximab) within 6 months prior to baseline (or until lymphocytes normalize, whichever longer). * Blood products within 4 weeks prior to baseline or planned during participation. * Live (attenuated) vaccines within 28 days prior to baseline or planned during the study. * Pregnant or breastfeeding, or planning pregnancy during the study or within 4 months after last dose. * Known/suspected allergy to ARQ-234 or its excipients. * Unable to communicate/understand the local language or otherwise unsuitable per investigator. * Family member of study staff or sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE) | 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. | From Baseline to Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile | From Baseline to Week 16 |
| Percentage of participants achieving at least a 50% improvement from baseline in EASI total score (EASI-50) | From Baseline to Week 16 |
| Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75) | From Baseline to Week 16 |
| Absolute change and percent change from baseline in the percentage of body surface area affected by atopic dermatitis | From Baseline to Week 16 |
| Absolute change and percent change from baseline in itch severity as measured by the Itch Numeric Rating Scale | From Baseline to Week 16 |
| Absolute change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score | From Baseline to Week 16 |
| Percentage of participants achieving at least a 50% improvement from baseline in SCORAD total score | From Baseline to Week 16 |
| Percentage of participants achieving at least a 75% improvement from baseline in SCORAD score | From Baseline to Week 16 |
| Absolute change and percent change from baseline in Patient-Oriented Eczema Measure (POEM) score | 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 | From Baseline to Week 16 |
| Percentage of participants with a vIGA-AD score of 0 (Clear) | From Baseline to Week 16 |
Countries
United States
Contacts
CONTACTArcutis Medical Information
STUDY_DIRECTORDavid Berk, MD
Arcutis Biotherapeutics
Outcome results
None listed