Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:18 PM
Study NCT ID:
NCT07453602
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234
Sponsor:
Arcutis Biotherapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1a/1b, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234 in Healthy Volunteers and Subjects With Moderate to Severe Atopic Dermatitis.
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: