Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Last updated: January 3, 2025
Sponsor: Arcutis Biotherapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Warts

Rash

Psoriasis And Psoriatic Disorders

Treatment

Topical roflumilast

Clinical Study ID

NCT04286607
ARQ-151-306
  • Ages 2-11
  • All Genders

Study Summary

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants legally competent to sign and give informed consent or informed consentof legal guardian, and, if age appropriate, assent by the subject, as required bylocal laws

  • Males and females ages 2 years and older (inclusive)

  • Subjects with chronic plaque psoriasis who meet eligibility criteria and:

  1. Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or

  2. Are naïve to treatment with ARQ-151 cream (Cohort 2)

  • Females of childbearing potential (FOCBP) must have a negative pregnancy test at allstudy visits. In addition, sexually active FOCBP must agree to use at least one formof highly effective contraception throughout the trial.

Exclusion

Exclusion Criteria:

  • Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) thatprecluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.

  • 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.

  • Subjects with any serious medical condition or laboratory abnormality that wouldprevent study participation or place the subject at significant risk, as determinedby 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: 333
Treatment Group(s): 1
Primary Treatment: Topical roflumilast
Phase: 3
Study Start date:
February 12, 2020
Estimated Completion Date:
January 22, 2024

Study Description

This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis

Connect with a study center

  • Arcutis Biotherapeutics Clinical Site 132

    Calgary, Alberta T1Y 0B4
    Canada

    Site Not Available

  • 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 103

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 133

    Mississauga, Ontario L5H 1G9
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 140

    Ottawa, Ontario K2C 3N2
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 109

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 235

    Toronto, Ontario M4W 2N2
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 106

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 204

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 107

    Montreal, Quebec H3Z 2S6
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 126

    Québec, Quebec G1V4X7
    Canada

    Site Not Available

  • Arcutis Clinical Site 601

    Santo Domingo,
    Dominican Republic

    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 127

    Encinitas, California 92024
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 225

    Encino, California 91436
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 509

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 112

    Fremont, California 94538
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 120

    Irvine, California 92697
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 508

    Los Angeles, California 90057
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 511

    Rancho Santa Margarita, California 92688
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 123

    San Diego, California 92123
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 220

    San Diego, California 92123
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 136

    San Francisco, California 94132
    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 118

    Delray Beach, Florida 33484
    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 131

    Miami, Florida 33174
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 201

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 137

    Ocala, Florida 34470
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 105

    Sanford, Florida 32771
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 209

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Arcutis Clinical Site 602

    Boise, Idaho 83706
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 114

    Plainfield, Illinois 46168
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 102

    Rolling Meadows, Illinois 60008
    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 111

    Baton Rouge, Louisiana 70809
    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 125

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 138

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 101

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 116

    Clinton Township, Michigan 48038
    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 139

    Reno, Nevada 89509
    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 129

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 121

    New York, New York 10029
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 130

    Rochester, New York 14623
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 108

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 115

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 124

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 134

    Oklahoma City, Oklahoma 73118
    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 128

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 113

    Exton, Pennsylvania 19003
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 135

    Pittsburgh, Pennsylvania 15213
    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 104

    College Station, Texas 77845
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 119

    Dallas, Texas 75246
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 519

    Frisco, Texas 75034
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 238

    Houston, Texas 77030
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 110

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 117

    San Antonio, Texas 78229
    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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