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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04211389
Other study ID # ARQ-151-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 17, 2019
Est. completion date November 23, 2020

Study information

Verified date December 2022
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 vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis


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


Recruitment information / eligibility

Status Completed
Enrollment 442
Est. completion date November 23, 2020
Est. primary completion date November 23, 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: - Participants legally competent to sign and give informed consented and if appropriate assent 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 for children) as determined by the Investigator - Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree 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, physical examination, serum chemistry labs, hematology values, and urinalysis. - Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator. Exclusion Criteria: - 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. - Previous treatment with ARQ-151 or its active ingredient - 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:
ARQ-151 0.3% cream
ARQ-151 0.3% cream
ARQ-151 vehicle cream
ARQ-151 vehicle cream

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 234 Fredericton New Brunswick
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 204 Windsor Ontario
Canada Arcutis Biotherapeutics Clinical Site 232 Winnepeg Manitoba
United States Arcutis Biotherapeutics Clinical Site 206 Arlington Texas
United States Arcutis Biotherapeutics Clinical Site 239 Beverly Hills California
United States Arcutis Biotherapeutics Clinical Site 223 Boynton Beach Florida
United States Arcutis Biotherapeutics Clinical Site 229 Broomall Pennsylvania
United States Arcutis Biotherapeutics Clinical Site 237 DeLand Florida
United States Arcutis Biotherapeutics Clinical Site 212 Detroit Michigan
United States Arcutis Biotherapeutics Clinical Site 225 Encino California
United States Arcutis Biotherapeutics Clinical Site 216 Fridley Minnesota
United States Arcutis Biotherapeutics Clinical Site 238 Houston Texas
United States Arcutis Biotherapeutics Clinical Site 214 Indianapolis Indiana
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 217 Louisville Kentucky
United States Arcutis Biotherapeutics Clinical Site 213 Metairie Louisiana
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 201 North Miami Beach Florida
United States Arcutis Biotherapeutics Clinical Site 222 Oklahoma City Oklahoma
United States Arcutis Biotherapeutics Clinical Site 236 Portsmouth New Hampshire
United States Arcutis Biotherapeutics Clinical Site 240 Reno Nevada
United States Arcutis Biotherapeutics Clinical Site 230 Richmond Virginia
United States Arcutis Biotherapeutics Clinical Site 227 Saint Joseph Missouri
United States Arcutis Biotherapeutics Clinical Site 220 San Diego California
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 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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a =2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values. Week 8
Secondary Time to Achieve Psoriasis Area Severity Index-50 (PASI-50) The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The time to achieve PASI-50 (defined as a 50% reduction from baseline in PASI score) is presented, and is based on observed data only. Participants are included whether they achieved PASI-50 or not. From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 124 days)
Secondary Number of Participants Achieving Psoriasis Area Severity Index-75 (PASI-75) The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-75 (defined as a 75% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only. Baseline (Day 1) and Week 8
Secondary Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90) The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only. Baseline (Day 1) and Week 8
Secondary Number of Participants Achieving Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8 The number of participants with I-IGA score =2 at baseline achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a =2-grade improvement from baseline I-IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. Week 8
Secondary Number of Participants Achieving I-IGA Score of 'Clear' at Week 8 The number of participants achieving an IGA score of 0 ('clear') at Week 8 is presented (observed data only) for each arm. The I-IGA is a 5-point scale assessing the severity of intertriginous area plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. Week 8
Secondary Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score The number of participants achieving success in WI-NRS is presented. Success is defined as achievement of a = 4-point reduction in WI-NRS pruritus score in participants with WI-NRS pruritus score = 4 at baseline. The WI-NRS is a 10 point scale ranging from 0 ('no itch') to 10 ('worst itch imaginable') the participant experienced in the past 24 hours, with higher scores indicating greater symptoms severity. Results are based on observed data only. Baseline (Day 1) and Week 2, Week 4, Week 8
Secondary Change From Baseline in Psoriasis Symptoms Diary (PSD) Score The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The least squares (LS) mean (95% CI) change in PSD total score relative to baseline is presented for each treatment arm, with decreases from baseline indicating symptom improvement. Baseline (Day 1) and Weeks 4 and 8
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