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

Chronic Plaque Psoriasis Clinical Trial

— DERMIS-2  

Official title:

A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211389
• Other study ID #: ARQ-151-302
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

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