125 Participants NeededMy employer runs this trial

ARQ-234 for Eczema

Recruiting at 4 trial locations
AM
Overseen ByArcutis Medical Information

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ARQ-234, an experimental therapy, to assess its safety and effectiveness in people. It targets individuals with moderate to severe eczema (atopic dermatitis) who have not responded well to creams or other treatments. The trial evaluates different doses to determine the optimal and safest amount. Those who have had eczema for at least six months and experience significant daily discomfort may be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that participants must be able to discontinue prohibited medications. It's best to discuss your specific medications with the trial team to see if they are allowed.

Is there any evidence suggesting that ARQ-234 is likely to be safe for humans?

Recent studies have shown that ARQ-234 may benefit people with atopic dermatitis, also known as eczema, offering hope for its effects. However, as ARQ-234 is still in the early stages of human testing, detailed safety information is not yet available.

The primary goal of this early phase is to assess the safety of ARQ-234 and how well people tolerate it, including monitoring for any side effects. Since this marks the first human testing of ARQ-234, researchers proceed with caution. They begin with low doses and gradually increase them to observe reactions. This careful approach aims to ensure safety as much as possible.

Although detailed information is limited, testing in humans suggests promise based on earlier lab and animal studies. Participants in this study will contribute to gathering crucial safety information.12345

Why do researchers think this study treatment might be promising for eczema?

Unlike other treatments for eczema, which often include topical steroids or calcineurin inhibitors, ARQ-234 is unique because it targets the underlying inflammatory pathways in a novel way. Researchers are excited about ARQ-234 because it introduces a new mechanism of action that could potentially provide relief with fewer side effects. Additionally, ARQ-234's innovative approach may offer faster results, which is a significant improvement over the slow-acting nature of many current therapies.

What evidence suggests that ARQ-234 might be an effective treatment for eczema?

Research shows that ARQ-234 works by attaching to a specific part of the immune system called CD200R. This connection might help calm overactive immune cells, restoring balance to the immune system. A similar drug targeting CD200R showed promise in early studies for people with moderate to severe eczema, suggesting this method could be effective. Although direct evidence of ARQ-234's effectiveness in humans is not yet available, its mechanism has shown potential benefits in managing eczema symptoms. Participants in this trial will receive either ARQ-234 or a placebo to evaluate its effectiveness.26789

Who Is on the Research Team?

DB

David Berk, MD

Principal Investigator

Arcutis Biotherapeutics

Are You a Good Fit for This Trial?

This trial is for healthy adults or adults aged 18-65 with moderate to severe atopic dermatitis (eczema) who haven't responded well to standard treatments. Participants must meet weight requirements, use effective birth control, and not have serious infections, immune problems, recent cancers, or other major health issues.

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
See 6 more

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
See 24 more

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

Trial Overview

The study tests different doses of a new drug called ARQ-234 compared to placebo in both healthy volunteers and people with moderate to severe eczema. It aims to find out how safe the drug is and how the body responds over single or multiple doses.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ARQ-234Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arcutis Biotherapeutics, Inc.

Lead Sponsor

Trials
22
Recruited
7,600+

Citations

Arcutis Begins Enrolling Phase 1a/1b Study Evaluating ARQ ...

ARQ-234 binds to CD200R and has the potential to restore immune homeostasis by inducing inhibitory signaling on immune cells. CD200R has been ...

637 - ARQ-234: a high affinity CD200-Fc fusion protein for the ...

A CD200R agonist antibody has demonstrated efficacy in an early phase clinical trial of moderate to severe atopic dermatitis patients.

ARQ-234 for Eczema · Recruiting Participants for Phase ...

This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234.

The translational revolution in atopic dermatitis - PMC

Efficacy And Safety of Lebrikizumab in Moderate-to-Severe Atopic Dermatitis: Results from Two Phase 3, Randomized, Double-Blinded, Placebo-Controlled Trials.

Arcutis Launches First-in-Human Trial of CD200R Agonist ...

Arcutis announced its first-in-human phase 1a/1b trial of ARQ-234, a CD200R agonist, in healthy volunteers and adults with moderate to severe ...

Arcutis Begins Enrolling Phase 1a/1b Study Evaluating ...

The study's primary objectives are to evaluate the safety and tolerability of ARQ-234 and clinical improvement in adults with moderate to severe ...

ARQ-234

In recent preclinical and clinical studies, CD200R has been validated as a target in atopic dermatitis with evidence of durable biologic response, even after ...

Novel CD200R Agonist ARQ-234 Advances to First-in ...

The double-blind, randomized, placebo-controlled ARQ-234-131 study will assess safety, tolerability, pharmacokinetics, and early signs of ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41288059/

Efficacy and safety of Ivarmacitinib in moderate-to-severe ...

Conclusion: Ivarmacitinib demonstrates good efficacy and a favorable safety profile in moderate-to-severe AD patients, irrespective of previous ...