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Phosphodiesterase-4 (PDE4) Inhibitor

ARQ-151 Active for Atopic Dermatitis (INTEGUMENT-I Trial)

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights

INTEGUMENT-I Trial Summary

This study is evaluating whether a cream may help treat atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

INTEGUMENT-I Trial 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
Achievement of at least a 75% (percent) reduction in the Eczema Area and Severity Index (EASI-75) at Week 4
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 1
In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 2
+7 more

INTEGUMENT-I Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARQ-151 Cream 0.15%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
6,987 Total Patients Enrolled
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
7,981 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~157 spots leftby Apr 2025