Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Last updated: December 5, 2022
Sponsor: Arcutis Biotherapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Skin Wounds

Rash

Treatment

N/A

Clinical Study ID

NCT04211389
ARQ-151-302
  • Ages > 2
  • All Genders

Study Summary

This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants legally competent to sign and give informed consented and if appropriateassent as required by local laws
  • Males and females ages 2 years and older (inclusive)
  • Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months forchildren) as determined by the Investigator
  • Females of childbearing potential (FOCBP) must have a negative pregnancy test atScreening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP mustagree to use at least one form of highly effective contraception throughout the trial.
  • In good health as judged by the Investigator, based on medical history, physicalexamination, serum chemistry labs, hematology values, and urinalysis.
  • Subjects considered reliable and capable of adhering to the Protocol and visitschedule, according to the judgment of the Investigator.

Exclusion

Exclusion Criteria:

  • Planned excessive exposure of treated area(s) to either natural or artificialsunlight, tanning bed or other LED.
  • Females who are pregnant, wishing to become pregnant during the study, or arebreast-feeding.
  • Previous treatment with ARQ-151 or its active ingredient
  • Subjects with any serious medical condition or laboratory abnormality that wouldprevent study participation or place the subject at significant risk, asdetermined by the Investigator.
  • Subjects with a history of chronic alcohol or drug abuse within 6 months ofinitiation of investigational product
  • Subjects who are unable to communicate, read or understand the local language, orwho display another condition, which in the Investigator's opinion, makes themunsuitable for clinical study participation

Study Design

Total Participants: 442
Study Start date:
December 17, 2019
Estimated Completion Date:
November 23, 2020

Study Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis

Connect with a study center

  • Arcutis Biotherapeutics Clinical Site 207

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 226

    Surrey, British Columbia V3V0C6
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 232

    Winnepeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 234

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 205

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 218

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 235

    Toronto, Ontario M4W 2N2
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 204

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 203

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 239

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 225

    Encino, California 91436
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 220

    San Diego, California 92123
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 208

    Santa Monica, California 90404
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 215

    Santa Monica, California 90503
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 223

    Boynton Beach, Florida 91436
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 237

    DeLand, Florida 32720
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 202

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 228

    Largo, Florida 33770
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 201

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 209

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 214

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 217

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 211

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 213

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 224

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 212

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 216

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 227

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 219

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 231

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 240

    Reno, Nevada 89703
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 236

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 222

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 229

    Broomall, Pennsylvania 19008
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 233

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 221

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 206

    Arlington, Texas 76011
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 238

    Houston, Texas 77030
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 210

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 230

    Richmond, Virginia 23220
    United States

    Site Not Available

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