- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00601107
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis
April 2, 2014 updated by: Genzyme, a Sanofi Company
A Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in the Treatment of Subjects With Moderate to Severe Chronic Plaque Psoriasis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
111
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States
-
-
Arizona
-
Hot Springs, Arizona, United States
-
-
Arkansas
-
Little Rock, Arkansas, United States
-
-
California
-
Irvine, California, United States
-
Santa Monica, California, United States
-
-
Georgia
-
Alpharetta, Georgia, United States
-
-
Indiana
-
Indianapolis, Indiana, United States
-
-
Massachusetts
-
Andover, Massachusetts, United States
-
Boston, Massachusetts, United States
-
-
Michigan
-
Troy, Michigan, United States
-
West Bloomfield, Michigan, United States
-
-
Missouri
-
St. Louis, Missouri, United States
-
-
New Jersey
-
East Windsor, New Jersey, United States
-
-
New Mexico
-
Albuquerque, New Mexico, United States
-
-
New York
-
Stony Brook, New York, United States
-
-
South Carolina
-
Greer, South Carolina, United States
-
-
Tennessee
-
Nashville, Tennessee, United States
-
-
Texas
-
San Antonio, Texas, United States
-
-
Utah
-
Salt Lake City, Utah, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Doxercalciferol 2.5 mcg/day
Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
|
Other Names:
|
EXPERIMENTAL: Doxercalciferol 5 mcg/day
Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
|
Other Names:
|
EXPERIMENTAL: Doxercalciferol 7.5 mcg/day
Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
|
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination
Time Frame: Week 12 or Early Termination
|
PASI score: range: 0 (no disease) to 72 (maximal disease).
Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities.
For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked.
PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].
|
Week 12 or Early Termination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination
Time Frame: Week 24 or Early Termination
|
PASI score: range: 0 (no disease) to 72 (maximal disease).
Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities.
For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked.
PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].
|
Week 24 or Early Termination
|
Percentage of Participants With Static Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 12, 24 or Early Termination
Time Frame: Week 12 or Early Termination, Week 24 or Early Termination
|
Static PGA of psoriasis is scored on a 5-point scale (0 = clear to 4 = severe), reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions.
Clear (erythema: no, scale: no, induration: no thickness); Almost Clear (erythema: light pink, scale: fine scale, induration: barely palpable); Mild (erythema: light red, scale: coarse scale on most lesions, induration: slight but visible elevation, indistinct edges); Moderate (erythema: red, scale: coarse adherent scale predominates, induration: moderate elevation with edges); and Severe (erythema: dark red to purple, scale: thickened adherent scale, induration: marked thickness distinct and pronounced edges).
Percentage of participants with static PGA score of clear or almost clear are reported.
|
Week 12 or Early Termination, Week 24 or Early Termination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (ACTUAL)
February 1, 2009
Study Completion (ACTUAL)
June 1, 2009
Study Registration Dates
First Submitted
January 15, 2008
First Submitted That Met QC Criteria
January 24, 2008
First Posted (ESTIMATE)
January 25, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 5, 2014
Last Update Submitted That Met QC Criteria
April 2, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HECTPS02507
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moderate to Severe Chronic Plaque Psoriasis
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom
-
UCB Biopharma SRLActive, not recruitingModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisChina
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Canada
-
UCB Biopharma SRLCompletedModerate to Severe Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan
-
CelltrionRecruitingModerate to Severe Chronic Plaque PsoriasisEstonia
-
Biocon Biologics UK LtdActive, not recruitingModerate to Severe Chronic Plaque PsoriasisUnited States
-
Astellas Pharma IncBiogenCompleted
-
Shanghai Junshi Bioscience Co., Ltd.RecruitingModerate to Severe Chronic Plaque PsoriasisChina
-
Sun Pharmaceutical Industries LimitedRecruitingModerate-to-severe Chronic Plaque PsoriasisUnited States, Hungary, India, Poland, Slovakia, Spain
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States