Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Roflumilast foam 0.3%; Vehicle foam
Intervention description: experimental; experimental
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day
      for 56 days by subjects with scalp and body psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants legally competent to read, write, sign and give informed consent, or, in
             the case of adolscents, assent with consent of a parent(s) or legal guardian, as
             required by local laws.

          -  Males and females ages 12 years and older (inclusive) at the time of consent for
             assent (for adolescents).

          -  Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity
             (S-IGA) of at least Mild ('2') at Baseline.

          -  A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline.

          -  A PASI score of at least 2 (excluding the palms and soles) at Baseline.

          -  Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined
             by the Investigator. Stable disease for the past 4 weeks.

          -  Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at
             Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).

          -  Females of non-childbearing potential must either be post-menopausal with spontaneous
             amenorrhea for at least 12 months or have undergone surgical sterilization.

          -  Subjects in good health as judged by the Investigator, based on medical history,
             physical examination, vital signs, serum chemistry labs, hematology values, and
             urinalysis.

          -  Subjects are considered reliable and capable of adhering to the Protocol and visit
             schedule according to the Investigator judgment.

        Exclusion Criteria:

          -  Subjects who cannot discontinue medications and treatments prior to the Baseline visit
             and during the study according to Excluded Medications and Treatments.

          -  Planned excessive exposure of treated area(s) to either natural or artificial
             sunlight, tanning bed or other LED.

          -  Subjects currently taking lithium or antimalarial drugs.

          -  Planned initiation or changes to concomitant medication that could, in the opinion of
             the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).

          -  Current diagnosis of non-plaque forms of psoriasis (e.g., guttate,
             erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis).
             Current diagnosis of drug-induced psoriasis.

          -  Subjects with any condition on the treatment area which, in the opinion of the
             Investigator, could confound efficacy measurements.

          -  Known allergies to excipients in ARQ-154.

          -  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 for two weeks prior to the Baseline
             visit (Visit 2) and during the study.

          -  Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g.,
             efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital),
             phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit
             (Visit 2) and during the study.

          -  Subjects with PHQ-8 >/= 10 or modified PHQ-A >/= 10 at Screening or Baseline.

          -  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 the investigational product.

          -  Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2)
             or has a major surgery planned during the study.

          -  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.

          -  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 with active infection that required oral or intravenous administration of
             antibiotics, antifungal, or antiviral agents within 7 days of Baseline/Day 0.

          -  Subjects who are family members of the clinical study site, clinical study staff, or
             sponsor, or family members residing in the same household of enrolled subjects.