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

ConditionsAtopic Dermatitis (AD)Eczema
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArcutis Biotherapeutics, Inc.

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • ARQ-234

    Biological/Vaccine

    ARQ-234 subcutaneous injectable solution

  • Placebo

    Drug

    Placebo subcutaneous injectable solution

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: ARQ-234Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number 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)
2

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

Secondary outcomes

1

Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile

Time frame
From Baseline to Week 16
2

Percentage of participants achieving at least a 50% improvement from baseline in EASI total score (EASI-50)

Time frame
From Baseline to Week 16
3

Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75)

Time frame
From Baseline to Week 16
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arcutis Biotherapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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