NCT00601107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

May 5, 2014

Completed
Last Updated

May 5, 2014

Status Verified

April 1, 2014

Enrollment Period

10 months

First QC Date

January 15, 2008

Results QC Date

April 2, 2014

Last Update Submit

April 2, 2014

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Keywords

psoriasispsoriasis vulgarisplaque psoriasischronic plaque psoriasis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at 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 Outcomes (2)

  • Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination

    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

    Week 12 or Early Termination, Week 24 or Early Termination

Study Arms (4)

Doxercalciferol 2.5 mcg/day

EXPERIMENTAL

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

Drug: Doxercalciferol

Doxercalciferol 5 mcg/day

EXPERIMENTAL

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

Drug: Doxercalciferol

Doxercalciferol 7.5 mcg/day

EXPERIMENTAL

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

Drug: Doxercalciferol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DoxercalciferolDRUG
Also known as: Hectorol®
Doxercalciferol 2.5 mcg/dayDoxercalciferol 5 mcg/dayDoxercalciferol 7.5 mcg/day
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Hot Springs, Arizona, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Irvine, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Alpharetta, Georgia, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Andover, Massachusetts, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Troy, Michigan, United States

Location

Unknown Facility

West Bloomfield, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

East Windsor, New Jersey, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Stony Brook, New York, United States

Location

Unknown Facility

Greer, South Carolina, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-us@sanofi.com

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 25, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2009

Study Completion

June 1, 2009

Last Updated

May 5, 2014

Results First Posted

May 5, 2014

Record last verified: 2014-04

Locations

US(19)