A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis
Condition: Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Doxercalciferol; Placebo
Intervention MeSH terms: 1 alpha-hydroxyergocalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; psoriasis vulgaris; plaque psoriasis; chronic plaque psoriasis

Summary:

      The purpose of this study was to evaluate the safety and effectiveness of an investigational
      drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis,
      in comparison with a placebo ("sugar pill"). All study related care was provided including
      doctor visits, physical exams, laboratory tests and study medication. Total length of
      participation was 28 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had moderate to severe chronic plaque psoriasis defined by a body surface
             area (BSA) involvement greater than or equal to (>=) 10 percent (%) and plaques with
             at least a slight elevation above the surrounding normal skin at the Day 1 visit

          -  Participant had a static Physician's Global Assessment (PGA) of moderate or severe at
             the Day 1 visit

          -  Participant had a minimum PASI score of 10 at the Day 1 visit

          -  Participant was a candidate to receive systemic psoriasis therapy in the opinion of
             the Investigator

          -  Participant of childbearing potential, was willing to use an effective contraceptive
             method throughout the study, which included barrier methods, hormones, or intrauterine
             devices

        Exclusion Criteria:

          -  Used vitamin D analogues, multivitamin supplements containing greater than (>) 400
             international unit (IU) vitamin D, topical retinoids, topical pimecrolimus, and
             topical tacrolimus within 14 days prior to the Day 1 visit

          -  Used drugs known to influence serum calcium (such as lithium, digoxin, thiazide
             diuretics, teriparatide, bisphosphonates, and calcitonin) and multivitamin supplements
             containing calcium and/or calcium-containing antacids exceeding a total of 1 gram/day
             within 14 days prior to the Day 1 visit

          -  Used keratolytics or coal tar (except shampoo containing coal tar or salicylic acid)
             within 14 days prior to the Day 1 visit

          -  Used low potency topical corticosteroids (Classes VI and VII), except on the groin,
             scalp, palms, soles and face, within 14 days prior to the Day 1 visit

          -  Used medium potency topical corticosteroids (Classes III - V) or high potency topical
             corticosteroids (Classes I and II) within 14 days prior to the Day 1 visit

          -  Used systemic retinoids, systemic corticosteroids, methotrexate, cyclosporine,
             azathioprine, thioguanine or other systemic immunosuppressant agents within 28 days
             prior to the Day 1 visit

          -  Used phototherapy, including Ultraviolet B within 14 days or Psoralen plus Ultraviolet
             A within 28 days prior to the Day 1 visit

          -  Used a biological agent (including, but not limited to, etanercept, adalimumab,
             efalizumab, infliximab, or alefacept) within 5 half-lives of the drug prior to the Day
             1 visit

          -  Used systemic antibiotics within 14 days prior to the Day 1 visit. Antibiotic
             treatment of infections during the Treatment Period was not excluded

          -  Used investigational drugs within 28 days prior to the Day 1 visit

          -  Current erythrodermic, guttate, generalized pustular, unstable psoriasis or other
             chronic active skin conditions that may interfere with the study

          -  Screening visit laboratory result exceeded the following limits: alanine transaminase
             (ALT) or aspartate transaminase (AST) >1.5 times the upper limit of normal (ULN);
             bilirubin >ULN; serum creatinine, calcium, or phosphorus >ULN; spot urine
             calcium/creatinine ratio >0.4

          -  History of nephrolithiasis

          -  Chronic kidney disease as evidenced by a calculated glomerular filtration rate (GFR)
             less than (<) 60 milliliter/minute/1.73 square meter (mL/min/1.73 m^2) at the
             screening visit

          -  Symptomatic coronary or cerebral vascular disease, human immunodeficiency virus,
             active viral hepatitis, or any other clinically significant, unstable medical
             condition that would interfere with the completion of the study

          -  Clinically significant electrocardiogram (EKG) abnormality at screening

          -  Any evidence of active malignancy except for basal cell carcinoma of the skin. A
             history of malignancy was not an exclusion

          -  Active ethanol or drug abuse, excluding tobacco use

          -  Active severe psychiatric illness that could interfere with the conduct of the study

          -  Pregnant or breast-feeding women

          -  Known allergy or hypersensitivity to vitamin D or other ingredients in the study drug
             formulation