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

Chronic Plaque Psoriasis Clinical Trial

— DERMIS-1  

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: NCT04211363
• Other study ID #: ARQ-151-301
• Status: Completed
• Phase: Phase 3
• Start date: December 20, 2019
• Est. completion date: November 16, 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 is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Participants legally competent to sign and give informed consent 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:
• Roflumilast 0.3% cream
Roflumilast 0.3% cream for topical application.
• Vehicle Cream
Vehicle cream for topical application.

Locations

Country	Name	City	State
Canada	Arcutis Biotherapeutics Clinical Site 132	Calgary	Alberta
Canada	Arcutis Biotherapeutics Clinical Site 103	London	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 122	Markham	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 106	Waterloo	Ontario
United States	Arcutis Biotherapeutics Clinical Site 111	Baton Rouge	Louisiana
United States	Arcutis Biotherapeutics Clinical Site 101	Brighton	Massachusetts
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 118	Delray Beach	Florida
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 113	Exton	Pennsylvania
United States	Arcutis Biotherapeutics Clinical Site 124	Fairborn	Ohio
United States	Arcutis Biotherapeutics Clinical Site 112	Fremont	California
United States	Arcutis Biotherapeutics Clinical Site 115	High Point	North Carolina
United States	Arcutis Biotherapeutics Clinical Site 120	Irvine	California
United States	Arcutis Biotherapeutics Clinical Site 131	Miami	Florida
United States	Arcutis Biotherapeutics Clinical Site 121	New York	New York
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 135	Pittsburgh	Pennsylvania
United States	Arcutis Biotherapeutics Clinical Site 114	Plainfield	Illinois
United States	Arcutis Biotherapeutics Clinical Site 139	Reno	Nevada
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 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 136	San Francisco	California
United States	Arcutis Biotherapeutics Clinical Site 105	Sanford	Florida
United States	Arcutis Biotherapeutics Clinical Site 108	Stony Brook	New York

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 in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8	The number of participants 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 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 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.	Baseline (Day 1) and 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.	From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 121 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)	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 0 (no disease) to 72 (maximal disease) [higher scores indicate 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 Intertriginous IGA (I-IGA) Success at Week 8	The number of participants achieving I-IGA success at Week 8 is presented. Success is defined as achievement of I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8 PLUS a =2-grade improvement in score from Baseline. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater symptom severity. Participant counts are based on observed data only.	Baseline (Day 1) and Week 8
Secondary	Number of Participants Achieving Score of 'Clear' in I-IGA 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 plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'); higher scores indicate greater symptom severity.	Week 8
Secondary	Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success	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'), with higher scores indicating greater symptoms severity. Results are based on observed data only.	Baseline (Day 1) and Weeks 2, 4, and 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.	Weeks 4 and 8