Psoriasis Clinical Trial
Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
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
Full Description
This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 67 Locations for this study
Beverly Hills California, 90212, United States
Encinitas California, 92024, United States
Encino California, 91436, United States
Fountain Valley California, 92708, United States
Fremont California, 94538, United States
Los Angeles California, 90057, United States
Rancho Santa Margarita California, 92688, United States
San Diego California, 92123, United States
San Francisco California, 94132, United States
Santa Monica California, 90404, United States
Boynton Beach Florida, 91436, United States
Delray Beach Florida, 33484, United States
Hialeah Florida, 33016, United States
Largo Florida, 33770, United States
Miami Florida, 33174, United States
North Miami Beach Florida, 33162, United States
Ocala Florida, 34470, United States
Sanford Florida, 32771, United States
Sweetwater Florida, 33172, United States
Boise Idaho, 83706, United States
Plainfield Illinois, 46168, United States
Rolling Meadows Illinois, 60008, United States
Indianapolis Indiana, 46250, United States
Louisville Kentucky, 40217, United States
Baton Rouge Louisiana, 70809, United States
Lake Charles Louisiana, 70605, United States
Metairie Louisiana, 70006, United States
New Orleans Louisiana, 70115, United States
Rockville Maryland, 20850, United States
Rockville Maryland, 20850, United States
Brighton Massachusetts, 02135, United States
Clinton Township Michigan, 48038, United States
Fridley Minnesota, 55432, United States
Saint Joseph Missouri, 64506, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89148, United States
Reno Nevada, 89509, United States
Reno Nevada, 89703, United States
Portsmouth New Hampshire, 03801, United States
East Windsor New Jersey, 08520, United States
New York New York, 10029, United States
Rochester New York, 14623, United States
Stony Brook New York, 11790, United States
Fairborn Ohio, 45324, United States
Oklahoma City Oklahoma, 73112, United States
Oklahoma City Oklahoma, 73118, United States
Duncansville Pennsylvania, 16635, United States
Knoxville Tennessee, 37922, United States
Murfreesboro Tennessee, 37130, United States
Arlington Texas, 76011, United States
College Station Texas, 77845, United States
Dallas Texas, 75246, United States
Frisco Texas, 75034, United States
Houston Texas, 77030, United States
San Antonio Texas, 78218, United States
San Antonio Texas, 78229, United States
Calgary Alberta, T1Y 0, Canada
Surrey British Columbia, V3R 6, Canada
Surrey British Columbia, V3V0C, Canada
Winnepeg Manitoba, R3M 3, Canada
Fredericton New Brunswick, E3B 1, Canada
Ajax Ontario, L1S 7, Canada
Barrie Ontario, L4M 7, Canada
London Ontario, N6H 5, Canada
Mississauga Ontario, L5H 1, Canada
Ottawa Ontario, K2C 3, Canada
Peterborough Ontario, K9J 5, Canada
Toronto Ontario, M4W 2, Canada
Waterloo Ontario, N2J 1, Canada
Québec Quebec, G1V4X, Canada
Santo Domingo , , Dominican Republic
How clear is this clinincal trial information?