Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Roflumilast
Intervention description: Roflumilast cream 0.3% for topical application
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Note: Subjects that consent to enter this open-label safety study have previously completed a companion study (ARQ-151-201 Phase 2 randomized controlled trial)
Masking: None (Open Label)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants legally competent to sign and give informed consent

          2. Males and females ages 18 years and older

          3. 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).

          4. 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.

          5. 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).

        Exclusion Criteria:

          1. 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.

          2. Subjects that use any Excluded Medications and Treatments

          3. Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar, or pustular
             psoriasis.

          4. 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.

          5. 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.

          6. Known or suspected:

               -  severe renal insufficiency or severe hepatic disorders

               -  hypersensitivity to component(s) of the investigational products

               -  history of severe depression, suicidal ideation

          7. Females who are pregnant, wishing to become pregnant during the study, or are
             breast-feeding.

          8. 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.

          9. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation
             of study medication.

         10. 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.

         11. 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.