Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: Roflumilast 0.3% cream; Drug: Vehicle Cream

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y 0B4
      • Arcutis Biotherapeutics Clinical Site 132
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Arcutis Biotherapeutics Clinical Site 103
    • Markham, Ontario, Canada, L3P 1X2
      • Arcutis Biotherapeutics Clinical Site 122
    • Mississauga, Ontario, Canada, L5H 1G9
      • Arcutis Biotherapeutics Clinical Site 133
    • Ottawa, Ontario, Canada, K2C 3N2
      • Arcutis Biotherapeutics Clinical Site 140
    • Peterborough, Ontario, Canada, K9J 5K2
      • Arcutis Biotherapeutics Clinical Site 109
    • Waterloo, Ontario, Canada, N2J 1C4
      • Arcutis Biotherapeutics Clinical Site 106
  • Quebec
    • Montreal, Quebec, Canada, H3Z 2S6
      • Arcutis Biotherapeutics Clinical Site 107
    • Québec, Quebec, Canada, G1V4X7
      • Arcutis Biotherapeutics Clinical Site 126
• United States
  • California
    • Encinitas, California, United States, 92024
      • Arcutis Biotherapeutics Clinical Site 127
    • Fremont, California, United States, 94538
      • Arcutis Biotherapeutics Clinical Site 112
    • Irvine, California, United States, 92697
      • Arcutis Biotherapeutics Clinical Site 120
    • San Diego, California, United States, 92123
      • Arcutis Biotherapeutics Clinical Site 123
    • San Francisco, California, United States, 94132
      • Arcutis Biotherapeutics Clinical Site 136
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Arcutis Biotherapeutics Clinical Site 118
    • Miami, Florida, United States, 33174
      • Arcutis Biotherapeutics Clinical Site 131
    • Ocala, Florida, United States, 34470
      • Arcutis Biotherapeutics Clinical Site 137
    • Sanford, Florida, United States, 32771
      • Arcutis Biotherapeutics Clinical Site 105
  • Illinois
    • Plainfield, Illinois, United States, 46168
      • Arcutis Biotherapeutics Clinical Site 114
    • Rolling Meadows, Illinois, United States, 60008
      • Arcutis Biotherapeutics Clinical Site 102
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Arcutis Biotherapeutics Clinical Site 111
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Arcutis Biotherapeutics Clinical Site 125
    • Rockville, Maryland, United States, 20850
      • Arcutis Biotherapeutics Clinical Site 138
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Arcutis Biotherapeutics Clinical Site 101
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Arcutis Biotherapeutics Clinical Site 116
  • Nevada
    • Reno, Nevada, United States, 89509
      • Arcutis Biotherapeutics Clinical Site 139
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Arcutis Biotherapeutics Clinical Site 129
  • New York
    • New York, New York, United States, 10029
      • Arcutis Biotherapeutics Clinical Site 121
    • Rochester, New York, United States, 14623
      • Arcutis Biotherapeutics Clinical Site 130
    • Stony Brook, New York, United States, 11790
      • Arcutis Biotherapeutics Clinical Site 108
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Arcutis Biotherapeutics Clinical Site 115
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Arcutis Biotherapeutics Clinical Site 124
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Arcutis Biotherapeutics Clinical Site 134
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Arcutis Biotherapeutics Clinical Site 128
    • Exton, Pennsylvania, United States, 19003
      • Arcutis Biotherapeutics Clinical Site 113
    • Pittsburgh, Pennsylvania, United States, 15213
      • Arcutis Biotherapeutics Clinical Site 135
  • Texas
    • College Station, Texas, United States, 77845
      • Arcutis Biotherapeutics Clinical Site 104
    • Dallas, Texas, United States, 75246
      • Arcutis Biotherapeutics Clinical Site 119
    • San Antonio, Texas, United States, 78218
      • Arcutis Biotherapeutics Clinical Site 110
    • San Antonio, Texas, United States, 78229
      • Arcutis Biotherapeutics Clinical Site 117

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rofumilast Cream 0.3%; Participants receive roflumilast cream 0.3% once daily for 8 weeks.	Drug: Roflumilast 0.3% cream; Roflumilast 0.3% cream for topical application.; Other Names: ARQ-151
Placebo Comparator: Vehicle cream; Participants receive vehicle cream once daily for 8 weeks.	Drug: Vehicle Cream; Vehicle cream for topical application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Arcutis Biotherapeutics, Inc.

Publications and helpful links

General Publications

• Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): November 16, 2020
• Study Completion (Actual): November 16, 2020

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: ARQ-151-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No