Psoriasis Clinical Trial

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

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

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Full Description

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
Males and females ages 2 years and older (inclusive)

Subjects with chronic plaque psoriasis who meet eligibility criteria and:

Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
Are naïve to treatment with ARQ-151 cream (Cohort 2)
Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.

Exclusion Criteria:

Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product.
Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

333

Study ID:

NCT04286607

Recruitment Status:

Completed

Sponsor:

Arcutis Biotherapeutics, Inc.

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There are 80 Locations for this study

See Locations Near You

Arcutis Biotherapeutics Clinical Site 203
Scottsdale Arizona, 85255, United States
Arcutis Biotherapeutics Clinical Site 239
Beverly Hills California, 90212, United States
Arcutis Biotherapeutics Clinical Site 127
Encinitas California, 92024, United States
Arcutis Biotherapeutics Clinical Site 225
Encino California, 91436, United States
Arcutis Biotherapeutics Clinical Site 509
Fountain Valley California, 92708, United States
Arcutis Biotherapeutics Clinical Site 112
Fremont California, 94538, United States
Arcutis Biotherapeutics Clinical Site 120
Irvine California, 92697, United States
Arcutis Biotherapeutics Clinical Site 508
Los Angeles California, 90057, United States
Arcutis Biotherapeutics Clinical Site 511
Rancho Santa Margarita California, 92688, United States
Arcutis Biotherapeutics Clinical Site 123
San Diego California, 92123, United States
Arcutis Biotherapeutics Clinical Site 220
San Diego California, 92123, United States
Arcutis Biotherapeutics Clinical Site 136
San Francisco California, 94132, United States
Arcutis Biotherapeutics Clinical Site 208
Santa Monica California, 90404, United States
Arcutis Biotherapeutics Clinical Site 215
Santa Monica California, 90503, United States
Arcutis Biotherapeutics Clinical Site 223
Boynton Beach Florida, 91436, United States
Arcutis Biotherapeutics Clinical Site 237
DeLand Florida, 32720, United States
Arcutis Biotherapeutics Clinical Site 118
Delray Beach Florida, 33484, United States
Arcutis Biotherapeutics Clinical Site 202
Hialeah Florida, 33016, United States
Arcutis Biotherapeutics Clinical Site 228
Largo Florida, 33770, United States
Arcutis Biotherapeutics Clinical Site 131
Miami Florida, 33174, United States
Arcutis Biotherapeutics Clinical Site 201
North Miami Beach Florida, 33162, United States
Arcutis Biotherapeutics Clinical Site 137
Ocala Florida, 34470, United States
Arcutis Biotherapeutics Clinical Site 105
Sanford Florida, 32771, United States
Arcutis Biotherapeutics Clinical Site 209
Sweetwater Florida, 33172, United States
Arcutis Clinical Site 602
Boise Idaho, 83706, United States
Arcutis Biotherapeutics Clinical Site 114
Plainfield Illinois, 46168, United States
Arcutis Biotherapeutics Clinical Site 102
Rolling Meadows Illinois, 60008, United States
Arcutis Biotherapeutics Clinical Site 214
Indianapolis Indiana, 46250, United States
Arcutis Biotherapeutics Clinical Site 217
Louisville Kentucky, 40217, United States
Arcutis Biotherapeutics Clinical Site 111
Baton Rouge Louisiana, 70809, United States
Arcutis Biotherapeutics Clinical Site 211
Lake Charles Louisiana, 70605, United States
Arcutis Biotherapeutics Clinical Site 213
Metairie Louisiana, 70006, United States
Arcutis Biotherapeutics Clinical Site 224
New Orleans Louisiana, 70115, United States
Arcutis Biotherapeutics Clinical Site 125
Rockville Maryland, 20850, United States
Arcutis Biotherapeutics Clinical Site 138
Rockville Maryland, 20850, United States
Arcutis Biotherapeutics Clinical Site 101
Brighton Massachusetts, 02135, United States
Arcutis Biotherapeutics Clinical Site 116
Clinton Township Michigan, 48038, United States
Arcutis Biotherapeutics Clinical Site 212
Detroit Michigan, 48202, United States
Arcutis Biotherapeutics Clinical Site 216
Fridley Minnesota, 55432, United States
Arcutis Biotherapeutics Clinical Site 227
Saint Joseph Missouri, 64506, United States
Arcutis Biotherapeutics Clinical Site 219
Las Vegas Nevada, 89148, United States
Arcutis Biotherapeutics Clinical Site 231
Las Vegas Nevada, 89148, United States
Arcutis Biotherapeutics Clinical Site 139
Reno Nevada, 89509, United States
Arcutis Biotherapeutics Clinical Site 240
Reno Nevada, 89703, United States
Arcutis Biotherapeutics Clinical Site 236
Portsmouth New Hampshire, 03801, United States
Arcutis Biotherapeutics Clinical Site 129
East Windsor New Jersey, 08520, United States
Arcutis Biotherapeutics Clinical Site 121
New York New York, 10029, United States
Arcutis Biotherapeutics Clinical Site 130
Rochester New York, 14623, United States
Arcutis Biotherapeutics Clinical Site 108
Stony Brook New York, 11790, United States
Arcutis Biotherapeutics Clinical Site 115
High Point North Carolina, 27262, United States
Arcutis Biotherapeutics Clinical Site 124
Fairborn Ohio, 45324, United States
Arcutis Biotherapeutics Clinical Site 222
Oklahoma City Oklahoma, 73112, United States
Arcutis Biotherapeutics Clinical Site 134
Oklahoma City Oklahoma, 73118, United States
Arcutis Biotherapeutics Clinical Site 229
Broomall Pennsylvania, 19008, United States
Arcutis Biotherapeutics Clinical Site 128
Duncansville Pennsylvania, 16635, United States
Arcutis Biotherapeutics Clinical Site 113
Exton Pennsylvania, 19003, United States
Arcutis Biotherapeutics Clinical Site 135
Pittsburgh Pennsylvania, 15213, United States
Arcutis Biotherapeutics Clinical Site 233
Knoxville Tennessee, 37922, United States
Arcutis Biotherapeutics Clinical Site 221
Murfreesboro Tennessee, 37130, United States
Arcutis Biotherapeutics Clinical Site 206
Arlington Texas, 76011, United States
Arcutis Biotherapeutics Clinical Site 104
College Station Texas, 77845, United States
Arcutis Biotherapeutics Clinical Site 119
Dallas Texas, 75246, United States
Arcutis Biotherapeutics Clinical Site 519
Frisco Texas, 75034, United States
Arcutis Biotherapeutics Clinical Site 238
Houston Texas, 77030, United States
Arcutis Biotherapeutics Clinical Site 110
San Antonio Texas, 78218, United States
Arcutis Biotherapeutics Clinical Site 117
San Antonio Texas, 78229, United States
Arcutis Biotherapeutics Clinical Site 210
West Jordan Utah, 84088, United States
Arcutis Biotherapeutics Clinical Site 230
Richmond Virginia, 23220, United States
Arcutis Biotherapeutics Clinical Site 132
Calgary Alberta, T1Y 0, Canada
Arcutis Biotherapeutics Clinical Site 207
Surrey British Columbia, V3R 6, Canada
Arcutis Biotherapeutics Clinical Site 226
Surrey British Columbia, V3V0C, Canada
Arcutis Biotherapeutics Clinical Site 232
Winnepeg Manitoba, R3M 3, Canada
Arcutis Biotherapeutics Clinical Site 234
Fredericton New Brunswick, E3B 1, Canada
Arcutis Biotherapeutics Clinical Site 205
Ajax Ontario, L1S 7, Canada
Arcutis Biotherapeutics Clinical Site 218
Barrie Ontario, L4M 7, Canada
Arcutis Biotherapeutics Clinical Site 103
London Ontario, N6H 5, Canada
Arcutis Biotherapeutics Clinical Site 133
Mississauga Ontario, L5H 1, Canada
Arcutis Biotherapeutics Clinical Site 140
Ottawa Ontario, K2C 3, Canada
Arcutis Biotherapeutics Clinical Site 109
Peterborough Ontario, K9J 5, Canada
Arcutis Biotherapeutics Clinical Site 235
Toronto Ontario, M4W 2, Canada
Arcutis Biotherapeutics Clinical Site 106
Waterloo Ontario, N2J 1, Canada
Arcutis Biotherapeutics Clinical Site 204
Windsor Ontario, N8W 1, Canada
Arcutis Biotherapeutics Clinical Site 107
Montreal Quebec, H3Z 2, Canada
Arcutis Biotherapeutics Clinical Site 126
Québec Quebec, G1V4X, Canada
Arcutis Clinical Site 601
Santo Domingo , , Dominican Republic

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

333

Study ID:

NCT04286607

Recruitment Status:

Completed

Sponsor:


Arcutis Biotherapeutics, Inc.

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