ARQ-234 for Eczema
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a Single Ascending Dose (SAD)
ARQ-234 is assessed in single ascending dose cohorts in healthy volunteers and participants with atopic dermatitis
Phase 1b Multiple Ascending Dose (MAD)
ARQ-234 is assessed in multiple ascending dose cohorts in participants with atopic dermatitis
Phase 1b Proof-of-Concept (POC) Expansion
ARQ-234 is assessed in participants with atopic dermatitis in an expansion cohort
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arcutis Biotherapeutics, Inc.
Lead Sponsor
Citations
1.
investors.arcutis.com
investors.arcutis.com/news-releases/news-release-details/arcutis-begins-enrolling-phase-1a1b-study-evaluating-arq-234/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.
5.
practicaldermatology.com
practicaldermatology.com/news/arcutis-launches-first-in-human-trial-of-cd200r-agonist-arq-234-in-atopic-dermatitis/2485894/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 ...
8.
dermatologytimes.com
dermatologytimes.com/view/novel-cd200r-agonist-arq-234-advances-to-first-in-human-study-in-adNovel 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 ...
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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.