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

Study Purpose

This study will assess the safety and efficacy of ARQ-151 cream vs.#46;placebo applied once a day for 56 days by subjects with chronic plaque psoriasis

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04211389
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arcutis Biotherapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Berk, MD
Principal Investigator Affiliation Arcutis Biotherapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Plaque Psoriasis
Additional Details

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

Arms & Interventions

Arms

Active Comparator: ARQ-151 cream 0.3%

Active comparator

Placebo Comparator: ARQ-151 cream vehicle

Placebo comparator

Interventions

Drug: - ARQ-151 0.3% cream

ARQ-151 0.3% cream

Drug: - ARQ-151 vehicle cream

ARQ-151 vehicle cream

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scottsdale, Arizona

Status

Address

Arcutis Biotherapeutics Clinical Site 203

Scottsdale, Arizona, 85255

Beverly Hills, California

Status

Address

Arcutis Biotherapeutics Clinical Site 239

Beverly Hills, California, 90212

Encino, California

Status

Address

Arcutis Biotherapeutics Clinical Site 225

Encino, California, 91436

San Diego, California

Status

Address

Arcutis Biotherapeutics Clinical Site 220

San Diego, California, 92123

Santa Monica, California

Status

Address

Arcutis Biotherapeutics Clinical Site 208

Santa Monica, California, 90404

Santa Monica, California

Status

Address

Arcutis Biotherapeutics Clinical Site 215

Santa Monica, California, 90503

Boynton Beach, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 223

Boynton Beach, Florida, 91436

DeLand, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 237

DeLand, Florida, 32720

Largo, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 228

Largo, Florida, 33770

North Miami Beach, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 201

North Miami Beach, Florida, 33162

Sweetwater, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 209

Sweetwater, Florida, 33172

Indianapolis, Indiana

Status

Address

Arcutis Biotherapeutics Clinical Site 214

Indianapolis, Indiana, 46250

Louisville, Kentucky

Status

Address

Arcutis Biotherapeutics Clinical Site 217

Louisville, Kentucky, 40217

Lake Charles, Louisiana

Status

Address

Arcutis Biotherapeutics Clinical Site 211

Lake Charles, Louisiana, 70605

Metairie, Louisiana

Status

Address

Arcutis Biotherapeutics Clinical Site 213

Metairie, Louisiana, 70006

New Orleans, Louisiana

Status

Address

Arcutis Biotherapeutics Clinical Site 224

New Orleans, Louisiana, 70115

Detroit, Michigan

Status

Address

Arcutis Biotherapeutics Clinical Site 212

Detroit, Michigan, 48202

Fridley, Minnesota

Status

Address

Arcutis Biotherapeutics Clinical Site 216

Fridley, Minnesota, 55432

Saint Joseph, Missouri

Status

Address

Arcutis Biotherapeutics Clinical Site 227

Saint Joseph, Missouri, 64506

Las Vegas, Nevada

Status

Address

Arcutis Biotherapeutics Clinical Site 219

Las Vegas, Nevada, 89148

Las Vegas, Nevada

Status

Address

Arcutis Biotherapeutics Clinical Site 231

Las Vegas, Nevada, 89148

Reno, Nevada

Status

Address

Arcutis Biotherapeutics Clinical Site 240

Reno, Nevada, 89703

Portsmouth, New Hampshire

Status

Address

Arcutis Biotherapeutics Clinical Site 236

Portsmouth, New Hampshire, 03801

Oklahoma City, Oklahoma

Status

Address

Arcutis Biotherapeutics Clinical Site 222

Oklahoma City, Oklahoma, 73112

Broomall, Pennsylvania

Status

Address

Arcutis Biotherapeutics Clinical Site 229

Broomall, Pennsylvania, 19008

Knoxville, Tennessee

Status

Address

Arcutis Biotherapeutics Clinical Site 233

Knoxville, Tennessee, 37922

Murfreesboro, Tennessee

Status

Address

Arcutis Biotherapeutics Clinical Site 221

Murfreesboro, Tennessee, 37130

Arlington, Texas

Status

Address

Arcutis Biotherapeutics Clinical Site 206

Arlington, Texas, 76011

Houston, Texas

Status

Address

Arcutis Biotherapeutics Clinical Site 238

Houston, Texas, 77030

West Jordan, Utah

Status

Address

Arcutis Biotherapeutics Clinical Site 210

West Jordan, Utah, 84088

Richmond, Virginia

Status

Address

Arcutis Biotherapeutics Clinical Site 230

Richmond, Virginia, 23220

International Sites

Surrey, British Columbia, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 207

Surrey, British Columbia, V3R 6A7

Surrey, British Columbia, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 226

Surrey, British Columbia, V3V0C6

Winnepeg, Manitoba, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 232

Winnepeg, Manitoba, R3M 3Z4

Fredericton, New Brunswick, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 234

Fredericton, New Brunswick, E3B 1G9

Ajax, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 205

Ajax, Ontario, L1S 7K8

Barrie, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 218

Barrie, Ontario, L4M 7G1

Toronto, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 235

Toronto, Ontario, M4W 2N2

Windsor, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 204

Windsor, Ontario, N8W 1E6

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