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NCT03638258 · ClinicalTrials.gov registry record · Phase 2

The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

A Phase 2 study of Plaque Psoriasis, sponsored by Arcutis Biotherapeutics.

Completed
Registry status
Phase 2
Development phase
331
Enrollment target
20
Study locations

NCT03638258 is a Phase 2 study of Plaque Psoriasis that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 331 participants, below the 409-participant average among 45 other Plaque Psoriasis trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT03638258, a Phase 2 study of Plaque Psoriasis, has completed, sponsored by Arcutis Biotherapeutics.

COMPLETED
Registry status
Phase 2
Development phase
331 participants
Enrollment target
20
Study locations

Study Summary

This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

Conditions Studied

Interventions

  • DRUG Vehicle Cream
  • DRUG Roflumilast Cream 0.3%
  • DRUG Roflumilast Cream 0.15%

Study Locations (20)

Texas

  • Arcutis Clinical Site 19 - College Station
  • Arcutis Clinical Site 37 - Houston
  • Arcutis Clinical Site 13 - Houston
  • Arcutis Clinical Site 23 - San Antonio
  • Arcutis Clinical Site 24 - Webster

California

  • Arcutis Clinical Site 35 - Beverly Hills
  • Arcutis Clinical Site 29 - Northridge
  • Arcutis Clinical Site 28 - San Diego
  • Arcutis Clinical Site 27 - Santa Monica

Florida

  • Arcutis Clinical Site 12 - Miami
  • Arcutis Clinical Site 16 - Sanford

Michigan

  • Arcutis Clinical Site 34 - Clinton Township
  • Arcutis Clinical Site 33 - Detroit

Kentucky

  • Arcutis Clinical Site 21 - Louisville

Minnesota

  • Arcutis Clinical Site 20 - Fridley

New York

  • Arcutis Clinical Site 22 - New York

North Carolina

  • Arcutis Clinical Site 14 - High Point

Trial Details

FieldValue
Enrollment Target 331 participants
Start Date 2018-09-21
Est. Completion 2019-05-29
Phase Phase 2

Sponsor

Arcutis Biotherapeutics

25 total trials

What the Registry Record Tells You About NCT03638258

The ClinicalTrials.gov registry entry for NCT03638258 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 409-participant average among 45 other Plaque Psoriasis trials with a reported enrollment target (19% lower). The listed sponsor is Arcutis Biotherapeutics, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Plaque Psoriasis appearing as the primary indexed condition, and to 3 interventions - of which Vehicle Cream is the first listed.

NCT03638258 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Texas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT03638258 about?

NCT03638258 is a clinical study titled "The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis". This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

What is the current status of trial NCT03638258?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 331 participants. The study started on 2018-09-21. Estimated completion is 2019-05-29.

What conditions does trial NCT03638258 study?

This clinical trial studies the following conditions: Plaque Psoriasis.

What interventions are being tested in trial NCT03638258?

The interventions under investigation include: Vehicle Cream (DRUG), Roflumilast Cream 0.3% (DRUG), Roflumilast Cream 0.15% (DRUG).

Who is sponsoring clinical trial NCT03638258?

This trial is sponsored by Arcutis Biotherapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03638258 being conducted?

This trial has 20 study locations across California, Florida, Kentucky, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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