Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-2)

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 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

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis
• Intervention / Treatment: Drug: ARQ-151 0.3% cream; Drug: ARQ-151 vehicle cream

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 442
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Arcutis Biotherapeutics Clinical Site 207
    • Surrey, British Columbia, Canada, V3V0C6
      • Arcutis Biotherapeutics Clinical Site 226
  • Manitoba
    • Winnepeg, Manitoba, Canada, R3M 3Z4
      • Arcutis Biotherapeutics Clinical Site 232
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Arcutis Biotherapeutics Clinical Site 234
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • Arcutis Biotherapeutics Clinical Site 205
    • Barrie, Ontario, Canada, L4M 7G1
      • Arcutis Biotherapeutics Clinical Site 218
    • Toronto, Ontario, Canada, M4W 2N2
      • Arcutis Biotherapeutics Clinical Site 235
    • Windsor, Ontario, Canada, N8W 1E6
      • Arcutis Biotherapeutics Clinical Site 204
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Arcutis Biotherapeutics Clinical Site 203
  • California
    • Beverly Hills, California, United States, 90212
      • Arcutis Biotherapeutics Clinical Site 239
    • Encino, California, United States, 91436
      • Arcutis Biotherapeutics Clinical Site 225
    • San Diego, California, United States, 92123
      • Arcutis Biotherapeutics Clinical Site 220
    • Santa Monica, California, United States, 90404
      • Arcutis Biotherapeutics Clinical Site 208
    • Santa Monica, California, United States, 90503
      • Arcutis Biotherapeutics Clinical Site 215
  • Florida
    • Boynton Beach, Florida, United States, 91436
      • Arcutis Biotherapeutics Clinical Site 223
    • DeLand, Florida, United States, 32720
      • Arcutis Biotherapeutics Clinical Site 237
    • Largo, Florida, United States, 33770
      • Arcutis Biotherapeutics Clinical Site 228
    • North Miami Beach, Florida, United States, 33162
      • Arcutis Biotherapeutics Clinical Site 201
    • Sweetwater, Florida, United States, 33172
      • Arcutis Biotherapeutics Clinical Site 209
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Arcutis Biotherapeutics Clinical Site 214
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Arcutis Biotherapeutics Clinical Site 217
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Arcutis Biotherapeutics Clinical Site 211
    • Metairie, Louisiana, United States, 70006
      • Arcutis Biotherapeutics Clinical Site 213
    • New Orleans, Louisiana, United States, 70115
      • Arcutis Biotherapeutics Clinical Site 224
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Arcutis Biotherapeutics Clinical Site 212
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Arcutis Biotherapeutics Clinical Site 216
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Arcutis Biotherapeutics Clinical Site 227
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Arcutis Biotherapeutics Clinical Site 219
    • Las Vegas, Nevada, United States, 89148
      • Arcutis Biotherapeutics Clinical Site 231
    • Reno, Nevada, United States, 89703
      • Arcutis Biotherapeutics Clinical Site 240
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Arcutis Biotherapeutics Clinical Site 236
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Arcutis Biotherapeutics Clinical Site 222
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Arcutis Biotherapeutics Clinical Site 229
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Arcutis Biotherapeutics Clinical Site 233
    • Murfreesboro, Tennessee, United States, 37130
      • Arcutis Biotherapeutics Clinical Site 221
  • Texas
    • Arlington, Texas, United States, 76011
      • Arcutis Biotherapeutics Clinical Site 206
    • Houston, Texas, United States, 77030
      • Arcutis Biotherapeutics Clinical Site 238
  • Utah
    • West Jordan, Utah, United States, 84088
      • Arcutis Biotherapeutics Clinical Site 210
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Arcutis Biotherapeutics Clinical Site 230

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 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 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
Active Comparator: ARQ-151 cream 0.3%; Active comparator	Drug: ARQ-151 0.3% cream; ARQ-151 0.3% cream
Placebo Comparator: ARQ-151 cream vehicle; Placebo comparator	Drug: ARQ-151 vehicle cream; ARQ-151 vehicle cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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. 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)
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)	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
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
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
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
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

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 17, 2019
• Primary Completion (Actual): November 23, 2020
• Study Completion (Actual): November 23, 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-151-302

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