A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis

NCT ID: NCT00601107

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-06-30

Brief 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.

Detailed Description

This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate the efficacy and safety of doxercalciferol given orally, once daily for 24 weeks to participants with moderate to severe chronic plaque psoriasis. Participants were randomized and stratified by site and Psoriasis Area Severity Index (PASI) score to one of three active treatment groups or to the placebo group.

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Doxercalciferol 2.5 mcg/day

Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.

Group Type: EXPERIMENTAL

Doxercalciferol

Intervention Type: DRUG

Doxercalciferol 5 mcg/day

Doxercalciferol 5 mcg capsules orally once daily up to Week 24.

Group Type: EXPERIMENTAL

Doxercalciferol

Intervention Type: DRUG

Doxercalciferol 7.5 mcg/day

Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.

Group Type: EXPERIMENTAL

Doxercalciferol

Intervention Type: DRUG

Placebo

Placebo matching to doxercalciferol capsules orally once daily up to Week 24.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Doxercalciferol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Hectorol®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Birmingham, Alabama, United States

Hot Springs, Arizona, United States

Little Rock, Arkansas, United States

Irvine, California, United States

Santa Monica, California, United States

Alpharetta, Georgia, United States

Indianapolis, Indiana, United States

Andover, Massachusetts, United States

Boston, Massachusetts, United States

Troy, Michigan, United States

West Bloomfield, Michigan, United States

St Louis, Missouri, United States

East Windsor, New Jersey, United States

Albuquerque, New Mexico, United States

Stony Brook, New York, United States

Greer, South Carolina, United States

Nashville, Tennessee, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

HECTPS02507

Identifier Type: -

Identifier Source: org_study_id