ARQ-234

DEVELOPMENT STEP NDA

SPONSOR MATRIX Arcutis Biotherapeutics [ARQT]

MECHANISM TARGET // UNMAPPED_TARGET

[THERAPEUTIC_PROFILE]

Target Indications

Atopic Dermatitis

Mechanism Abstract

A small molecule inhibitor of phosphodiesterase-4

[CLINICAL_TRIALS_REGISTRY]

TOTAL EXTRACTED1

RECRUITING STATUS1

COMPLETED RUNS0

REGISTRY & PHASE

TESTED CONDITION

STUDY TITLE & LIFECYCLE TIMELINES

STATUS

➔

P-1NCT07453602

Atopic Dermatitis (AD)Eczema

N=125Est. Finish: 2028-04

Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234

recruiting

ENROLLMENT PATIENT CAPACITY125 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2026-03-02(actual)

Primary End:2028-04(estimated)

Study Finish:2028-04(estimated)

OFFICIAL PROTOCOL 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.

[INVESTIGATORS_&_FACILITY_ROSTER]

David Berk, MDSTUDY DIRECTOR — Arcutis Biotherapeutics

Clinical Site 101CONTACT — Clinical Site 101

Arcutis Medical InformationCONTACT — Arcutis Biotherapeutics, Inc.

[PRIMARY_SUCCESS_ENDPOINTS]

Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)

Analysis Window: 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.