The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

Study Purpose

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream 0.3% or ARQ-151 cream 0.15% or vehicle cream is applied once daily for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants legally competent to sign and give informed consent - Males and females ages 18 years and older (inclusive) - Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator - Females of childbearing potential (FOCBP) must have a negative urine 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 are 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 or tanning bed.
  • - 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 study medication.
  • - 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.

NCT03638258
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 2
Lead Sponsor

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

Arcutis, Inc.
Principal Investigator

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

Howard Welgus, MD
Principal Investigator Affiliation Arcutis, Inc.
Agency Class

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

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

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

Plaque Psoriasis

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.

Arcutis Clinical Site 35, Beverly Hills, California

Status

Recruiting

Address

Arcutis Clinical Site 35

Beverly Hills, California, 90212

Site Contact

650-847-4115

Arcutis Clinical Site 29, Northridge, California

Status

Recruiting

Address

Arcutis Clinical Site 29

Northridge, California, 91324

Site Contact

650-847-4115

Arcutis Clinical Site 28, San Diego, California

Status

Recruiting

Address

Arcutis Clinical Site 28

San Diego, California, 92123

Site Contact

650-847-4115

Arcutis Clinical Site 27, Santa Monica, California

Status

Recruiting

Address

Arcutis Clinical Site 27

Santa Monica, California, 90403

Site Contact

650-847-4115

Arcutis Clinical Site 12, Miami, Florida

Status

Recruiting

Address

Arcutis Clinical Site 12

Miami, Florida, 33144

Site Contact

650-847-4115

Arcutis Clinical Site 16, Sanford, Florida

Status

Recruiting

Address

Arcutis Clinical Site 16

Sanford, Florida, 32771

Site Contact

650-847-4115

Arcutis Clinical Site 21, Louisville, Kentucky

Status

Recruiting

Address

Arcutis Clinical Site 21

Louisville, Kentucky, 40217

Site Contact

650-847-4115

Arcutis Clinical Site 34, Clinton Township, Michigan

Status

Recruiting

Address

Arcutis Clinical Site 34

Clinton Township, Michigan, 48038

Site Contact

650-847-4115

Arcutis Clinical Site 33, Detroit, Michigan

Status

Recruiting

Address

Arcutis Clinical Site 33

Detroit, Michigan, 48202

Site Contact

650-847-4115

Arcutis Clinical Site 20, Fridley, Minnesota

Status

Recruiting

Address

Arcutis Clinical Site 20

Fridley, Minnesota, 55432

Site Contact

650-847-4115

Arcutis Clinical Site 22, New York, New York

Status

Recruiting

Address

Arcutis Clinical Site 22

New York, New York, 10029

Site Contact

650-847-4115

Arcutis Clinical Site 14, High Point, North Carolina

Status

Recruiting

Address

Arcutis Clinical Site 14

High Point, North Carolina, 27262

Site Contact

650-847-4115

Arcutis Clinical Site 39, Bexley, Ohio

Status

Recruiting

Address

Arcutis Clinical Site 39

Bexley, Ohio, 43209

Site Contact

650-847-4115

Arcutis Clinical Site 15, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Arcutis Clinical Site 15

Pittsburgh, Pennsylvania, 15213

Site Contact

650-847-4115

Arcutis Clinical Site 19, College Station, Texas

Status

Recruiting

Address

Arcutis Clinical Site 19

College Station, Texas, 77845

Site Contact

650-847-4115

Arcutis Clinical Site 37, Houston, Texas

Status

Recruiting

Address

Arcutis Clinical Site 37

Houston, Texas, 77004

Site Contact

650-847-4115

Arcutis Clinical Site 13, Houston, Texas

Status

Recruiting

Address

Arcutis Clinical Site 13

Houston, Texas, 77056

Site Contact

650-847-4115

Arcutis Clinical Site 23, San Antonio, Texas

Status

Recruiting

Address

Arcutis Clinical Site 23

San Antonio, Texas, 78213

Site Contact

650-847-4115

Arcutis Clinical Site 24, Webster, Texas

Status

Recruiting

Address

Arcutis Clinical Site 24

Webster, Texas, 77598

Site Contact

650-847-4115

Arcutis Clinical Site 31, Norfolk, Virginia

Status

Recruiting

Address

Arcutis Clinical Site 31

Norfolk, Virginia, 23502

Site Contact

650-847-4115

International Sites

Arcutis Clinical Site 18, Surrey, British Columbia, Canada

Status

Recruiting

Address

Arcutis Clinical Site 18

Surrey, British Columbia, V3R 6A7

Site Contact

650-847-4115

Arcutis Clinical Site 11, Surrey, British Columbia, Canada

Status

Recruiting

Address

Arcutis Clinical Site 11

Surrey, British Columbia, V3V 0C6

Site Contact

650-847-4115

Arcutis Clinical Site 38, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Arcutis Clinical Site 38

Winnipeg, Manitoba, R3M 3Z4

Site Contact

650-847-4115

Arcutis Clinical Site 10, Ajax, Ontario, Canada

Status

Recruiting

Address

Arcutis Clinical Site 10

Ajax, Ontario, L1S 7K8

Site Contact

650-847-4115

Arcutis Clinical Site 25, London, Ontario, Canada

Status

Recruiting

Address

Arcutis Clinical Site 25

London, Ontario, N6H 5L5

Site Contact

650-847-4115

Arcutis Clinical Site 26, Markham, Ontario, Canada

Status

Recruiting

Address

Arcutis Clinical Site 26

Markham, Ontario, L3P 1X2

Site Contact

650-847-4115

Arcutis Clinical Site 32, Oakville, Ontario, Canada

Status

Recruiting

Address

Arcutis Clinical Site 32

Oakville, Ontario, L6J 7W5

Site Contact

650-847-4115

Arcutis Clinical Site 17, Peterborough, Ontario, Canada

Status

Recruiting

Address

Arcutis Clinical Site 17

Peterborough, Ontario, K9J 5K2

Site Contact

650-847-4115

Arcutis Clinical Site 30, Waterloo, Ontario, Canada

Status

Recruiting

Address

Arcutis Clinical Site 30

Waterloo, Ontario, N2J 1C4

Site Contact

650-847-4115

Arcutis Clinical Site 36, Windsor, Ontario, Canada

Status

Recruiting

Address

Arcutis Clinical Site 36

Windsor, Ontario, N8W 1E6

Site Contact

650-847-4115

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