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 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.

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.

NCT04211363
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.

N/A
Principal Investigator Affiliation N/A
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.

Encinitas, California

Status

Address

Arcutis Biotherapeutics Clinical Site 127

Encinitas, California, 92024

Fremont, California

Status

Address

Arcutis Biotherapeutics Clinical Site 112

Fremont, California, 94538

Irvine, California

Status

Address

Arcutis Biotherapeutics Clinical Site 120

Irvine, California, 92697

San Diego, California

Status

Address

Arcutis Biotherapeutics Clinical Site 123

San Diego, California, 92123

San Francisco, California

Status

Address

Arcutis Biotherapeutics Clinical Site 136

San Francisco, California, 94132

Delray Beach, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 118

Delray Beach, Florida, 33484

Miami, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 131

Miami, Florida, 33174

Ocala, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 137

Ocala, Florida, 34470

Sanford, Florida

Status

Address

Arcutis Biotherapeutics Clinical Site 105

Sanford, Florida, 32771

Plainfield, Illinois

Status

Address

Arcutis Biotherapeutics Clinical Site 114

Plainfield, Illinois, 46168

Rolling Meadows, Illinois

Status

Address

Arcutis Biotherapeutics Clinical Site 102

Rolling Meadows, Illinois, 60008

Baton Rouge, Louisiana

Status

Address

Arcutis Biotherapeutics Clinical Site 111

Baton Rouge, Louisiana, 70809

Rockville, Maryland

Status

Address

Arcutis Biotherapeutics Clinical Site 125

Rockville, Maryland, 20850

Rockville, Maryland

Status

Address

Arcutis Biotherapeutics Clinical Site 138

Rockville, Maryland, 20850

Brighton, Massachusetts

Status

Address

Arcutis Biotherapeutics Clinical Site 101

Brighton, Massachusetts, 02135

Clinton Township, Michigan

Status

Address

Arcutis Biotherapeutics Clinical Site 116

Clinton Township, Michigan, 48038

Reno, Nevada

Status

Address

Arcutis Biotherapeutics Clinical Site 139

Reno, Nevada, 89509

East Windsor, New Jersey

Status

Address

Arcutis Biotherapeutics Clinical Site 129

East Windsor, New Jersey, 08520

New York, New York

Status

Address

Arcutis Biotherapeutics Clinical Site 121

New York, New York, 10029

Rochester, New York

Status

Address

Arcutis Biotherapeutics Clinical Site 130

Rochester, New York, 14623

Stony Brook, New York

Status

Address

Arcutis Biotherapeutics Clinical Site 108

Stony Brook, New York, 11790

High Point, North Carolina

Status

Address

Arcutis Biotherapeutics Clinical Site 115

High Point, North Carolina, 27262

Fairborn, Ohio

Status

Address

Arcutis Biotherapeutics Clinical Site 124

Fairborn, Ohio, 45324

Oklahoma City, Oklahoma

Status

Address

Arcutis Biotherapeutics Clinical Site 134

Oklahoma City, Oklahoma, 73118

Duncansville, Pennsylvania

Status

Address

Arcutis Biotherapeutics Clinical Site 128

Duncansville, Pennsylvania, 16635

Exton, Pennsylvania

Status

Address

Arcutis Biotherapeutics Clinical Site 113

Exton, Pennsylvania, 19003

Pittsburgh, Pennsylvania

Status

Address

Arcutis Biotherapeutics Clinical Site 135

Pittsburgh, Pennsylvania, 15213

College Station, Texas

Status

Address

Arcutis Biotherapeutics Clinical Site 104

College Station, Texas, 77845

Dallas, Texas

Status

Address

Arcutis Biotherapeutics Clinical Site 119

Dallas, Texas, 75246

San Antonio, Texas

Status

Address

Arcutis Biotherapeutics Clinical Site 110

San Antonio, Texas, 78218

San Antonio, Texas

Status

Address

Arcutis Biotherapeutics Clinical Site 117

San Antonio, Texas, 78229

International Sites

Calgary, Alberta, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 132

Calgary, Alberta, T1Y 0B4

London, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 103

London, Ontario, N6H 5L5

Markham, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 122

Markham, Ontario, L3P 1X2

Mississauga, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 133

Mississauga, Ontario, L5H 1G9

Ottawa, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 140

Ottawa, Ontario, K2C 3N2

Peterborough, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 109

Peterborough, Ontario, K9J 5K2

Waterloo, Ontario, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 106

Waterloo, Ontario, N2J 1C4

Montreal, Quebec, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 107

Montreal, Quebec, H3Z 2S6

Québec, Quebec, Canada

Status

Address

Arcutis Biotherapeutics Clinical Site 126

Québec, Quebec, G1V4X7

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