Psoriasis Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility 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 roflumilast cream 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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

331

Study ID:

NCT03638258

Recruitment Status:

Completed

Sponsor:

Arcutis Biotherapeutics, Inc.

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There are 30 Locations for this study

See Locations Near You

Arcutis Clinical Site 35
Beverly Hills California, 90212, United States
Arcutis Clinical Site 29
Northridge California, 91324, United States
Arcutis Clinical Site 28
San Diego California, 92123, United States
Arcutis Clinical Site 27
Santa Monica California, 90403, United States
Arcutis Clinical Site 12
Miami Florida, 33144, United States
Arcutis Clinical Site 16
Sanford Florida, 32771, United States
Arcutis Clinical Site 21
Louisville Kentucky, 40217, United States
Arcutis Clinical Site 34
Clinton Township Michigan, 48038, United States
Arcutis Clinical Site 33
Detroit Michigan, 48202, United States
Arcutis Clinical Site 20
Fridley Minnesota, 55432, United States
Arcutis Clinical Site 22
New York New York, 10029, United States
Arcutis Clinical Site 14
High Point North Carolina, 27262, United States
Arcutis Clinical Site 39
Bexley Ohio, 43209, United States
Arcutis Clinical Site 15
Pittsburgh Pennsylvania, 15213, United States
Arcutis Clinical Site 19
College Station Texas, 77845, United States
Arcutis Clinical Site 37
Houston Texas, 77004, United States
Arcutis Clinical Site 13
Houston Texas, 77056, United States
Arcutis Clinical Site 23
San Antonio Texas, 78213, United States
Arcutis Clinical Site 24
Webster Texas, 77598, United States
Arcutis Clinical Site 31
Norfolk Virginia, 23502, United States
Arcutis Clinical Site 18
Surrey British Columbia, V3R 6, Canada
Arcutis Clinical Site 11
Surrey British Columbia, V3V 0, Canada
Arcutis Clinical Site 38
Winnipeg Manitoba, R3M 3, Canada
Arcutis Clinical Site 10
Ajax Ontario, L1S 7, Canada
Arcutis Clinical Site 25
London Ontario, N6H 5, Canada
Arcutis Clinical Site 26
Markham Ontario, L3P 1, Canada
Arcutis Clinical Site 32
Oakville Ontario, L6J 7, Canada
Arcutis Clinical Site 17
Peterborough Ontario, K9J 5, Canada
Arcutis Clinical Site 30
Waterloo Ontario, N2J 1, Canada
Arcutis Clinical Site 36
Windsor Ontario, N8W 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

331

Study ID:

NCT03638258

Recruitment Status:

Completed

Sponsor:


Arcutis Biotherapeutics, Inc.

How clear is this clinincal trial information?

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