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PDE4 Inhibitor

ARQ-151 Active for Atopic Dermatitis

Phase 3
Waitlist Available
Research Sponsored by Arcutis Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of a new cream for eczema to a placebo cream.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4.
Secondary outcome measures
In subjects with vIGA-AD score of 'Moderate' at randomization, IGA Success at Week 4
In subjects with vIGA-AD score of 'Moderate' at randomization, achievement of at least 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4
In subjects with vIGA-AD score of 'Moderate' at randomization, vIGA-AD score of 'clear' or 'almost clear' at Week 4
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARQ-151 Cream 0.05%Experimental Treatment1 Intervention
Active comparator
Group II: ARQ-151 Vehicle CreamPlacebo Group1 Intervention
Placebo comparator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARQ-151 Active
2021
Completed Phase 3
~1310

Find a Location

Who is running the clinical trial?

Arcutis Biotherapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
6,989 Total Patients Enrolled
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
7,983 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell me the ARQ-151 Active clinical trial results in terms of patient safety?

"There is some evidence to support the efficacy of ARQ-151 Active, as it has reached Phase 3 in clinical trials. Additionally, there is sufficient data suggesting that ARQ-151 Active is safe for human use."

Answered by AI

Does this research project target seniors specifically?

"This trial is specifically for children aged 2 to 5. In total, there are 110 clinical trials involving pediatric patients and 181 trials for elderly patients."

Answered by AI

What are the goals that participants of this study hope to achieve?

"The primary outcome of this study is IGA Success, which will be evaluated over the course of roughly Week 4. IGA Success is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4. Secondary outcomes include The proportion of randomized subjects with a vIGA-AD score of 'Moderate' at randomization who attain IGA Success and the Proportion of patients with vIGA-AD score of 'clear' or 'almost clear'. The vIGA-AD is a static evaluation of qualitative overall AD severity. This"

Answered by AI

Are numerous hospitals testing this medication in the United States today?

"84 other locations are also running this trial, such as the Arcutis Clinical Site in Bellaire, Sacramento, and Frisco."

Answered by AI

How can I get involved in the research being conducted?

"This clinical trial is looking for 650 participants, between the ages of 2 and 5, who currently have dermatitis. It is important that participants also meet the following criteria: Informed consent by parent(s) or legal guardian as required by local laws., Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1)., Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening., In good health as judged by"

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Arcutis Clinical Site 26
What portion of applicants met pre-screening criteria?
Did not meet criteria
~163 spots leftby Apr 2025