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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
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 moreINTEGUMENT-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
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