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

NCT04211363 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARQ-151-301
• Study Type: interventional
• Target: 439
• Locations: 2 countries
• Sites: 40

Brief 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.

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 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 = 121 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 Intertriginous IGA (I-IGA) Success at Week 8

  Baseline (Day 1) and Week 8

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

  Week 8

Study Arms (2)

Rofumilast Cream 0.3%

EXPERIMENTAL

Participants receive roflumilast cream 0.3% once daily for 8 weeks.

Drug: Roflumilast 0.3% cream

Vehicle cream

PLACEBO COMPARATOR

Participants receive vehicle cream once daily for 8 weeks.

Drug: Vehicle Cream

Interventions

Roflumilast 0.3% cream DRUG

Roflumilast 0.3% cream for topical application.

Also known as: ARQ-151

Rofumilast Cream 0.3%

Vehicle Cream DRUG

Vehicle cream for topical application.

Vehicle cream

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 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.

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 (40)

Arcutis Biotherapeutics Clinical Site 127

Encinitas, California, 92024, United States

Location

Arcutis Biotherapeutics Clinical Site 112

Fremont, California, 94538, United States

Location

Arcutis Biotherapeutics Clinical Site 120

Irvine, California, 92697, United States

Location

Arcutis Biotherapeutics Clinical Site 123

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 136

San Francisco, California, 94132, United States

Location

Arcutis Biotherapeutics Clinical Site 118

Delray Beach, Florida, 33484, United States

Location

Arcutis Biotherapeutics Clinical Site 131

Miami, Florida, 33174, United States

Location

Arcutis Biotherapeutics Clinical Site 137

Ocala, Florida, 34470, United States

Location

Arcutis Biotherapeutics Clinical Site 105

Sanford, Florida, 32771, United States

Location

Arcutis Biotherapeutics Clinical Site 114

Plainfield, Illinois, 46168, United States

Location

Arcutis Biotherapeutics Clinical Site 102

Rolling Meadows, Illinois, 60008, United States

Location

Arcutis Biotherapeutics Clinical Site 111

Baton Rouge, Louisiana, 70809, United States

Location

Arcutis Biotherapeutics Clinical Site 125

Rockville, Maryland, 20850, United States

Location

Arcutis Biotherapeutics Clinical Site 138

Rockville, Maryland, 20850, United States

Location

Arcutis Biotherapeutics Clinical Site 101

Brighton, Massachusetts, 02135, United States

Location

Arcutis Biotherapeutics Clinical Site 116

Clinton Township, Michigan, 48038, United States

Location

Arcutis Biotherapeutics Clinical Site 139

Reno, Nevada, 89509, United States

Location

Arcutis Biotherapeutics Clinical Site 129

East Windsor, New Jersey, 08520, United States

Location

Arcutis Biotherapeutics Clinical Site 121

New York, New York, 10029, United States

Location

Arcutis Biotherapeutics Clinical Site 130

Rochester, New York, 14623, United States

Location

Arcutis Biotherapeutics Clinical Site 108

Stony Brook, New York, 11790, United States

Location

Arcutis Biotherapeutics Clinical Site 115

High Point, North Carolina, 27262, United States

Location

Arcutis Biotherapeutics Clinical Site 124

Fairborn, Ohio, 45324, United States

Location

Arcutis Biotherapeutics Clinical Site 134

Oklahoma City, Oklahoma, 73118, United States

Location

Arcutis Biotherapeutics Clinical Site 128

Duncansville, Pennsylvania, 16635, United States

Location

Arcutis Biotherapeutics Clinical Site 113

Exton, Pennsylvania, 19003, United States

Location

Arcutis Biotherapeutics Clinical Site 135

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Biotherapeutics Clinical Site 104

College Station, Texas, 77845, United States

Location

Arcutis Biotherapeutics Clinical Site 119

Dallas, Texas, 75246, United States

Location

Arcutis Biotherapeutics Clinical Site 110

San Antonio, Texas, 78218, United States

Location

Arcutis Biotherapeutics Clinical Site 117

San Antonio, Texas, 78229, United States

Location

Arcutis Biotherapeutics Clinical Site 132

Calgary, Alberta, T1Y 0B4, Canada

Location

Arcutis Biotherapeutics Clinical Site 103

London, Ontario, N6H 5L5, Canada

Location

Arcutis Biotherapeutics Clinical Site 122

Markham, Ontario, L3P 1X2, Canada

Location

Arcutis Biotherapeutics Clinical Site 133

Mississauga, Ontario, L5H 1G9, Canada

Location

Arcutis Biotherapeutics Clinical Site 140

Ottawa, Ontario, K2C 3N2, Canada

Location

Arcutis Biotherapeutics Clinical Site 109

Peterborough, Ontario, K9J 5K2, Canada

Location

Arcutis Biotherapeutics Clinical Site 106

Waterloo, Ontario, N2J 1C4, Canada

Location

Arcutis Biotherapeutics Clinical Site 107

Montreal, Quebec, H3Z 2S6, Canada

Location

Arcutis Biotherapeutics Clinical Site 126

Québec, Quebec, G1V4X7, 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

MeSH Terms

Interventions

Roflumilast

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844)692-6729

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 20, 2019
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: December 7, 2022
• Results First Posted: November 3, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (31); CA (9)