Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04286607 | Completed Phase 3 FDA Drug

• 1 other identifier: ARQ-151-306
• Study Type: interventional
• Target: 333
• Locations: 3 countries
• Sites: 85

Brief Summary

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment emergent AEs (TEAEs)

  The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs

  24 weeks

Secondary Outcomes (7)

• Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time.

  24 weeks

• In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response).

  24 weeks

• Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time

  24 weeks

• Achievement of a 75% reduction in PASI over time

  24 weeks

• Achievement of a 90% reduction in PASI over time

  24 weeks

Study Arms (1)

ARQ-151 Cream 0.3%

EXPERIMENTAL

Drug: Topical roflumilast

Interventions

Topical roflumilast DRUG

Active treatment

Also known as: ARQ-151 Cream 0.3%

ARQ-151 Cream 0.3%

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
• Males and females ages 2 years and older (inclusive)
• Subjects with chronic plaque psoriasis who meet eligibility criteria and:
• Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
• Are naïve to treatment with ARQ-151 cream (Cohort 2)
• Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.

You may not qualify if:

• Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
• 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.
• 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 (85)

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 127

Encinitas, California, 92024, United States

Location

Arcutis Biotherapeutics Clinical Site 225

Encino, California, 91436, United States

Location

Arcutis Biotherapeutics Clinical Site 509

Fountain Valley, California, 92708, 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 508

Los Angeles, California, 90057, United States

Location

Arcutis Biotherapeutics Clinical Site 511

Rancho Santa Margarita, California, 92688, United States

Location

Arcutis Biotherapeutics Clinical Site 123

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 220

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 136

San Francisco, California, 94132, 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 118

Delray Beach, Florida, 33484, United States

Location

Arcutis Biotherapeutics Clinical Site 202

Hialeah, Florida, 33016, United States

Location

Arcutis Biotherapeutics Clinical Site 228

Largo, Florida, 33770, United States

Location

Arcutis Biotherapeutics Clinical Site 131

Miami, Florida, 33174, United States

Location

Arcutis Biotherapeutics Clinical Site 201

North Miami Beach, Florida, 33162, 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 209

Sweetwater, Florida, 33172, United States

Location

Arcutis Clinical Site 602

Boise, Idaho, 83706, 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 214

Indianapolis, Indiana, 46250, United States

Location

Arcutis Biotherapeutics Clinical Site 217

Louisville, Kentucky, 40217, United States

Location

Arcutis Biotherapeutics Clinical Site 111

Baton Rouge, Louisiana, 70809, 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 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 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 139

Reno, Nevada, 89509, 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 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 222

Oklahoma City, Oklahoma, 73112, United States

Location

Arcutis Biotherapeutics Clinical Site 134

Oklahoma City, Oklahoma, 73118, United States

Location

Arcutis Biotherapeutics Clinical Site 229

Broomall, Pennsylvania, 19008, 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 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 104

College Station, Texas, 77845, United States

Location

Arcutis Biotherapeutics Clinical Site 119

Dallas, Texas, 75246, United States

Location

Arcutis Biotherapeutics Clinical Site 519

Frisco, Texas, 75034, United States

Location

Arcutis Biotherapeutics Clinical Site 238

Houston, Texas, 77030, 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 210

West Jordan, Utah, 84088, United States

Location

Arcutis Biotherapeutics Clinical Site 230

Richmond, Virginia, 23220, United States

Location

Arcutis Biotherapeutics Clinical Site 132

Calgary, Alberta, T1Y 0B4, Canada

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 103

London, Ontario, N6H 5L5, 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 235

Toronto, Ontario, M4W 2N2, Canada

Location

Arcutis Biotherapeutics Clinical Site 106

Waterloo, Ontario, N2J 1C4, Canada

Location

Arcutis Biotherapeutics Clinical Site 204

Windsor, Ontario, N8W 1E6, Canada

Location

Arcutis Biotherapeutics Clinical Site 107

Montreal, Quebec, H3Z 2S6, Canada

Location

Arcutis Biotherapeutics Clinical Site 126

Québec, Quebec, G1V4X7, Canada

Location

Arcutis Clinical Site 601

Santo Domingo, Dominican Republic

Location

MeSH Terms

Interventions

Roflumilast

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: February 12, 2020
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CA (16); US (68); DO (1)