Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

Completed · Phase 2

Conditions studied: Plaque Psoriasis

In brief

This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Key facts

Study ID

NCT03764475

Run by

Arcutis Biotherapeutics, Inc.

People needed

332

Starts

2018-12-18

Expected to finish

2020-10-08

Last updated by the study team

2022-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants legally competent to sign and give informed consent
• Males and females ages 18 years and older
• Subjects with chronic plaque psoriasis who met eligibility criteria for ARQ-151-201, successfully completed ARQ-151-201 through Week 12, and are able to enroll into this long-term safety study on the Week 12 visit of the previous study (ARQ-151-201).
• Females of childbearing potential (FOCBP) must have a negative urine 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. Highly effective forms of contraception include: oral/implant/injectable/transdermal contraceptives, intrauterine device, or partner's vasectomy. If barrier methods are used (e.g., condom with spermicide, diaphragm with spermicide), then 2 forms of conception are required. The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and a backup method has been identified if the subject becomes sexually active.
• Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).

You may not qualify if…

• Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in Study ARQ-151-201.
• Subjects that use any Excluded Medications and Treatments
• Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar, or pustular psoriasis.
• Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.
• Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin during the study period.
• Known or suspected:
• severe renal insufficiency or severe hepatic disorders
• hypersensitivity to component(s) of the investigational products
• history of severe depression, suicidal ideation
• 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 study medication.
• Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
• 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.

Where it is running

• Arcutis Clinical Site 35 — Beverly Hills, California, United States
• Arcutis Clinical Site 29 — Northridge, California, United States
• Arcutis Clinical Site 28 — San Diego, California, United States
• Arcutis Clinical Site 27 — Santa Monica, California, United States
• Arcutis Clinical Site 12 — Miami, Florida, United States
• Arcutis Clinical Site 16 — Sanford, Florida, United States
• Arcutis Clinical Site 21 — Louisville, Kentucky, United States
• Arcutis Clinical Site 34 — Clinton Township, Michigan, United States
• Arcutis Clinical Site 33 — Detroit, Michigan, United States
• Arcutis Clinical Site 20 — Fridley, Minnesota, United States
• Arcutis Clinical Site 22 — New York, New York, United States
• Arcutis Clinical Site 14 — High Point, North Carolina, United States
• Arcutis Clinical Site 39 — Bexley, Ohio, United States
• Arcutis Clinical Site 15 — Pittsburgh, Pennsylvania, United States
• Arcutis Clinical Site 19 — College Station, Texas, United States
• Arcutis Clinical Site 37 — Houston, Texas, United States
• Arcutis Clinical Site 13 — Houston, Texas, United States
• Arcutis Clinical Site 23 — San Antonio, Texas, United States
• Arcutis Clinical Site 24 — Webster, Texas, United States
• Arcutis Clinical Site 31 — Norfolk, Virginia, United States
• Arcutis Clinical Site 18 — Surrey, British Columbia, Canada
• Arcutis Clinical Site 11 — Surrey, British Columbia, Canada
• Arcutis Clinical Site 38 — Winnipeg, Manitoba, Canada
• Arcutis Clinical Site 10 — Ajax, Ontario, Canada
• Arcutis Clinical Site 25 — London, Ontario, Canada

Full record on ClinicalTrials.gov

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