A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Belumosudil
Intervention MeSH terms: Belumosudil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the safety and tolerability of 200 mg of belumosudil
      administered orally once daily for 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderately severe plaque psoriasis that has been stable for 6 months and
             has failed at least one line of systemic therapy and is a candidate for additional
             systemic therapy.

          -  Had a PASI of ≥12

          -  At least 10% of body surface area that is affected by plaque psoriasis.

          -  Willing to avoid tanning devices or sun bathing.

          -  Willing to forgo systemic and topical treatments for psoriasis during the course of
             the study.

          -  Adequate bone marrow function

          -  Negative urine pregnancy test (for women of childbearing potential)

          -  Agree to use a highly effective method of birth control (< 1% per year failure rate)
             during the study and for 1 month after the termination of the study.

          -  Willing to complete all study measurements and assessments in compliance with the
             protocol.

        Exclusion Criteria:

          -  Non-plaque or drug-induced psoriasis

          -  Currently using corticosteroid or immunosuppressive therapy except for Class 5 or
             weaker topical corticosteroids to the face, groin, or scalp

          -  Using any topical therapy except for the following:

               1. Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry

               2. Immunosuppressive therapies for 4 weeks prior to study entry

               3. Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry

               4. Biologic therapies for 3 months prior to study entry.

          -  Concomitant condition requiring treatment with moderate to high dose steroids in the
             12 weeks prior to screening.

          -  Viral, fungal, or bacterial skin infection.

          -  Pregnant or lactating woman.

          -  Currently participating in another study with an investigational drug or within 28
             days of study entry

          -  History or other evidence of severe illness or any other conditions that would make
             the subject, in the opinion of the investigator, unsuitable for the study

          -  History or presence of any of the following:

               1. Hepatic disease and or alanine aminotransferase (ALT) or aspartate
                  aminotransferase (AST) > 1.5 × the upper limit of normal (ULN) at screening

               2. Renal disease and/or serum creatinine > 1.5xULN at screening

          -  Has QTc(f) intervals of > 450 msec at the screening or pre-dose ECG

          -  Subject is receiving any drugs known to prolong the QTc interval, including any
             anti-arrhythmic medications within 2 weeks prior to screening

          -  Subject is receiving any drug that is a strong CYP enzyme inhibitor

          -  Subject is receiving any concomitant systemic drug that is metabolized by CYP enzyme

          -  Previous exposure to KD025 or known allergy/sensitivity to KD025 or any other ROCK-2
             inhibitor.