ARQ-234 for Eczema

Overseen By Arcutis Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Arcutis Biotherapeutics, Inc.

Must not be taking: Biologics, Antimicrobials

Disqualifiers: Renal impairment, Hepatic impairment, Malignancy, others

Compensation: Varies

Number of Visits: Unknown

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

David Berk, MD

Principal Investigator

Arcutis Biotherapeutics

Are You a Good Fit for This Trial?

Inclusion Criteria

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 must have 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 must agree to condom use during the study and for 4 months after last dose if sexually active with a pregnant partner or a female of childbearing potential

Able and willing to provide written informed consent

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Single Ascending Dose (SAD)

ARQ-234 is assessed in single ascending dose cohorts in healthy volunteers and participants with atopic dermatitis

4-6 weeks

Phase 1b Multiple Ascending Dose (MAD)

ARQ-234 is assessed in multiple ascending dose cohorts in participants with atopic dermatitis

6-8 weeks

Phase 1b Proof-of-Concept (POC) Expansion

ARQ-234 is assessed in participants with atopic dermatitis in an expansion cohort

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ARQ-234

How Is the Trial Designed?

Group I: ARQ-234 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Arcutis Biotherapeutics, Inc.

Lead Sponsor

Trials

22

Recruited

7,600+