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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04286607
Other study ID # ARQ-151-306
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 12, 2020
Est. completion date January 22, 2024

Study information

Verified date March 2024
Source Arcutis Biotherapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 333
Est. completion date January 22, 2024
Est. primary completion date January 22, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years to 11 Years
Eligibility 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: 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 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Topical roflumilast
Active treatment

Locations

Country Name City State
Canada Arcutis Biotherapeutics Clinical Site 205 Ajax Ontario
Canada Arcutis Biotherapeutics Clinical Site 218 Barrie Ontario
Canada Arcutis Biotherapeutics Clinical Site 132 Calgary Alberta
Canada Arcutis Biotherapeutics Clinical Site 234 Fredericton New Brunswick
Canada Arcutis Biotherapeutics Clinical Site 103 London Ontario
Canada Arcutis Biotherapeutics Clinical Site 133 Mississauga Ontario
Canada Arcutis Biotherapeutics Clinical Site 107 Montreal Quebec
Canada Arcutis Biotherapeutics Clinical Site 140 Ottawa Ontario
Canada Arcutis Biotherapeutics Clinical Site 109 Peterborough Ontario
Canada Arcutis Biotherapeutics Clinical Site 126 Québec Quebec
Canada Arcutis Biotherapeutics Clinical Site 207 Surrey British Columbia
Canada Arcutis Biotherapeutics Clinical Site 226 Surrey British Columbia
Canada Arcutis Biotherapeutics Clinical Site 235 Toronto Ontario
Canada Arcutis Biotherapeutics Clinical Site 106 Waterloo Ontario
Canada Arcutis Biotherapeutics Clinical Site 204 Windsor Ontario
Canada Arcutis Biotherapeutics Clinical Site 232 Winnepeg Manitoba
Dominican Republic Arcutis Clinical Site 601 Santo Domingo
United States Arcutis Biotherapeutics Clinical Site 206 Arlington Texas
United States Arcutis Biotherapeutics Clinical Site 111 Baton Rouge Louisiana
United States Arcutis Biotherapeutics Clinical Site 239 Beverly Hills California
United States Arcutis Clinical Site 602 Boise Idaho
United States Arcutis Biotherapeutics Clinical Site 223 Boynton Beach Florida
United States Arcutis Biotherapeutics Clinical Site 101 Brighton Massachusetts
United States Arcutis Biotherapeutics Clinical Site 229 Broomall Pennsylvania
United States Arcutis Biotherapeutics Clinical Site 116 Clinton Township Michigan
United States Arcutis Biotherapeutics Clinical Site 104 College Station Texas
United States Arcutis Biotherapeutics Clinical Site 119 Dallas Texas
United States Arcutis Biotherapeutics Clinical Site 237 DeLand Florida
United States Arcutis Biotherapeutics Clinical Site 118 Delray Beach Florida
United States Arcutis Biotherapeutics Clinical Site 212 Detroit Michigan
United States Arcutis Biotherapeutics Clinical Site 128 Duncansville Pennsylvania
United States Arcutis Biotherapeutics Clinical Site 129 East Windsor New Jersey
United States Arcutis Biotherapeutics Clinical Site 127 Encinitas California
United States Arcutis Biotherapeutics Clinical Site 225 Encino California
United States Arcutis Biotherapeutics Clinical Site 113 Exton Pennsylvania
United States Arcutis Biotherapeutics Clinical Site 124 Fairborn Ohio
United States Arcutis Biotherapeutics Clinical Site 509 Fountain Valley California
United States Arcutis Biotherapeutics Clinical Site 112 Fremont California
United States Arcutis Biotherapeutics Clinical Site 216 Fridley Minnesota
United States Arcutis Biotherapeutics Clinical Site 519 Frisco Texas
United States Arcutis Biotherapeutics Clinical Site 202 Hialeah Florida
United States Arcutis Biotherapeutics Clinical Site 115 High Point North Carolina
United States Arcutis Biotherapeutics Clinical Site 238 Houston Texas
United States Arcutis Biotherapeutics Clinical Site 214 Indianapolis Indiana
United States Arcutis Biotherapeutics Clinical Site 120 Irvine California
United States Arcutis Biotherapeutics Clinical Site 233 Knoxville Tennessee
United States Arcutis Biotherapeutics Clinical Site 211 Lake Charles Louisiana
United States Arcutis Biotherapeutics Clinical Site 228 Largo Florida
United States Arcutis Biotherapeutics Clinical Site 219 Las Vegas Nevada
United States Arcutis Biotherapeutics Clinical Site 231 Las Vegas Nevada
United States Arcutis Biotherapeutics Clinical Site 508 Los Angeles California
United States Arcutis Biotherapeutics Clinical Site 217 Louisville Kentucky
United States Arcutis Biotherapeutics Clinical Site 213 Metairie Louisiana
United States Arcutis Biotherapeutics Clinical Site 131 Miami Florida
United States Arcutis Biotherapeutics Clinical Site 221 Murfreesboro Tennessee
United States Arcutis Biotherapeutics Clinical Site 224 New Orleans Louisiana
United States Arcutis Biotherapeutics Clinical Site 121 New York New York
United States Arcutis Biotherapeutics Clinical Site 201 North Miami Beach Florida
United States Arcutis Biotherapeutics Clinical Site 137 Ocala Florida
United States Arcutis Biotherapeutics Clinical Site 134 Oklahoma City Oklahoma
United States Arcutis Biotherapeutics Clinical Site 222 Oklahoma City Oklahoma
United States Arcutis Biotherapeutics Clinical Site 135 Pittsburgh Pennsylvania
United States Arcutis Biotherapeutics Clinical Site 114 Plainfield Illinois
United States Arcutis Biotherapeutics Clinical Site 236 Portsmouth New Hampshire
United States Arcutis Biotherapeutics Clinical Site 511 Rancho Santa Margarita California
United States Arcutis Biotherapeutics Clinical Site 139 Reno Nevada
United States Arcutis Biotherapeutics Clinical Site 240 Reno Nevada
United States Arcutis Biotherapeutics Clinical Site 230 Richmond Virginia
United States Arcutis Biotherapeutics Clinical Site 130 Rochester New York
United States Arcutis Biotherapeutics Clinical Site 125 Rockville Maryland
United States Arcutis Biotherapeutics Clinical Site 138 Rockville Maryland
United States Arcutis Biotherapeutics Clinical Site 102 Rolling Meadows Illinois
United States Arcutis Biotherapeutics Clinical Site 227 Saint Joseph Missouri
United States Arcutis Biotherapeutics Clinical Site 110 San Antonio Texas
United States Arcutis Biotherapeutics Clinical Site 117 San Antonio Texas
United States Arcutis Biotherapeutics Clinical Site 123 San Diego California
United States Arcutis Biotherapeutics Clinical Site 220 San Diego California
United States Arcutis Biotherapeutics Clinical Site 136 San Francisco California
United States Arcutis Biotherapeutics Clinical Site 105 Sanford Florida
United States Arcutis Biotherapeutics Clinical Site 208 Santa Monica California
United States Arcutis Biotherapeutics Clinical Site 215 Santa Monica California
United States Arcutis Biotherapeutics Clinical Site 203 Scottsdale Arizona
United States Arcutis Biotherapeutics Clinical Site 108 Stony Brook New York
United States Arcutis Biotherapeutics Clinical Site 209 Sweetwater Florida
United States Arcutis Biotherapeutics Clinical Site 210 West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
Arcutis Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Dominican Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of treatment emergent AEs (TEAEs) The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs 24 weeks
Secondary Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time. 24 weeks
Secondary In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response). 24 weeks
Secondary Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time 24 weeks
Secondary Achievement of a 75% reduction in PASI over time 24 weeks
Secondary Achievement of a 90% reduction in PASI over time 24 weeks
Secondary Achievement of a 100% reduction in PASI over time 24 weeks
Secondary Change in Worst Itch Numeric Rating Scale) WI-NRS score over time 24 weeks
See also
  Status Clinical Trial Phase
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Completed NCT00799877 - Chronic Plaque Psoriasis (Ps) Registry
Completed NCT02581345 - Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis Phase 3
Withdrawn NCT01200264 - Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy Phase 2
Terminated NCT00972543 - Raptiva in Palm and Sole Psoriasis Phase 4
Not yet recruiting NCT00707070 - Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis Phase 4
Completed NCT00539929 - Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis Phase 2
Completed NCT02852967 - A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Phase 2
Completed NCT00770965 - Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis Phase 2
Active, not recruiting NCT06011733 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT00245765 - Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy Phase 2
Completed NCT00673556 - A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate Phase 3
Terminated NCT00844363 - Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris N/A
Completed NCT00574249 - Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment Phase 3
Completed NCT00512187 - Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial Phase 4
Completed NCT02570750 - The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Completed NCT00438360 - Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis Phase 3
Active, not recruiting NCT03897075 - Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis Phase 3
Completed NCT01358578 - Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis Phase 3
Completed NCT03536884 - A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3