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

NCT04211389 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARQ-151-302
• Study Type: interventional
• Target: 442
• Locations: 2 countries
• Sites: 39

Brief 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

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)

  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)

  Baseline (Day 1) and Week 8

• Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)

  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

  Week 8

• Number of Participants Achieving I-IGA Score of 'Clear' at Week 8

  Week 8

Study Arms (2)

ARQ-151 cream 0.3%

ACTIVE COMPARATOR

Active comparator

Drug: ARQ-151 0.3% cream

ARQ-151 cream vehicle

PLACEBO COMPARATOR

Placebo comparator

Drug: ARQ-151 vehicle cream

Interventions

ARQ-151 0.3% cream DRUG

ARQ-151 0.3% cream

ARQ-151 cream 0.3%

ARQ-151 vehicle cream DRUG

ARQ-151 vehicle cream

ARQ-151 cream vehicle

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (39)

Arcutis Biotherapeutics Clinical Site 203

Scottsdale, Arizona, 85255, United States

Location

Arcutis Biotherapeutics Clinical Site 239

Beverly Hills, California, 90212, United States

Location

Arcutis Biotherapeutics Clinical Site 225

Encino, California, 91436, United States

Location

Arcutis Biotherapeutics Clinical Site 220

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 208

Santa Monica, California, 90404, United States

Location

Arcutis Biotherapeutics Clinical Site 215

Santa Monica, California, 90503, United States

Location

Arcutis Biotherapeutics Clinical Site 223

Boynton Beach, Florida, 91436, United States

Location

Arcutis Biotherapeutics Clinical Site 237

DeLand, Florida, 32720, United States

Location

Arcutis Biotherapeutics Clinical Site 228

Largo, Florida, 33770, United States

Location

Arcutis Biotherapeutics Clinical Site 201

North Miami Beach, Florida, 33162, United States

Location

Arcutis Biotherapeutics Clinical Site 209

Sweetwater, Florida, 33172, United States

Location

Arcutis Biotherapeutics Clinical Site 214

Indianapolis, Indiana, 46250, United States

Location

Arcutis Biotherapeutics Clinical Site 217

Louisville, Kentucky, 40217, United States

Location

Arcutis Biotherapeutics Clinical Site 211

Lake Charles, Louisiana, 70605, United States

Location

Arcutis Biotherapeutics Clinical Site 213

Metairie, Louisiana, 70006, United States

Location

Arcutis Biotherapeutics Clinical Site 224

New Orleans, Louisiana, 70115, United States

Location

Arcutis Biotherapeutics Clinical Site 212

Detroit, Michigan, 48202, United States

Location

Arcutis Biotherapeutics Clinical Site 216

Fridley, Minnesota, 55432, United States

Location

Arcutis Biotherapeutics Clinical Site 227

Saint Joseph, Missouri, 64506, United States

Location

Arcutis Biotherapeutics Clinical Site 219

Las Vegas, Nevada, 89148, United States

Location

Arcutis Biotherapeutics Clinical Site 231

Las Vegas, Nevada, 89148, United States

Location

Arcutis Biotherapeutics Clinical Site 240

Reno, Nevada, 89703, United States

Location

Arcutis Biotherapeutics Clinical Site 236

Portsmouth, New Hampshire, 03801, United States

Location

Arcutis Biotherapeutics Clinical Site 222

Oklahoma City, Oklahoma, 73112, United States

Location

Arcutis Biotherapeutics Clinical Site 229

Broomall, Pennsylvania, 19008, United States

Location

Arcutis Biotherapeutics Clinical Site 233

Knoxville, Tennessee, 37922, United States

Location

Arcutis Biotherapeutics Clinical Site 221

Murfreesboro, Tennessee, 37130, United States

Location

Arcutis Biotherapeutics Clinical Site 206

Arlington, Texas, 76011, United States

Location

Arcutis Biotherapeutics Clinical Site 238

Houston, Texas, 77030, United States

Location

Arcutis Biotherapeutics Clinical Site 210

West Jordan, Utah, 84088, United States

Location

Arcutis Biotherapeutics Clinical Site 230

Richmond, Virginia, 23220, United States

Location

Arcutis Biotherapeutics Clinical Site 207

Surrey, British Columbia, V3R 6A7, Canada

Location

Arcutis Biotherapeutics Clinical Site 226

Surrey, British Columbia, V3V0C6, Canada

Location

Arcutis Biotherapeutics Clinical Site 232

Winnepeg, Manitoba, R3M 3Z4, Canada

Location

Arcutis Biotherapeutics Clinical Site 234

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Arcutis Biotherapeutics Clinical Site 205

Ajax, Ontario, L1S 7K8, Canada

Location

Arcutis Biotherapeutics Clinical Site 218

Barrie, Ontario, L4M 7G1, Canada

Location

Arcutis Biotherapeutics Clinical Site 235

Toronto, Ontario, M4W 2N2, Canada

Location

Arcutis Biotherapeutics Clinical Site 204

Windsor, Ontario, N8W 1E6, Canada

Location

Related Publications (3)

• Papp KA, Del Rosso JQ, Lebwohl MG, Gooderham MJ, Hebert AA, Hong HC, Kircik LH, Pariser DM, Stein Gold L, Strober B, Seal MS, Krupa D, Chu DH, Burnett P, Berk DR, Higham RC. Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3733-3744. doi: 10.1007/s13555-025-01562-4. Epub 2025 Oct 24.

  PMID: 41134450 DERIVED

• Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.

  PMID: 36422852 DERIVED

• 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.

  PMID: 36125472 DERIVED

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 26, 2019
• Study Start: December 17, 2019
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: December 7, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (31); CA (8)