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Randomized Placebo-Controlled Study of ISA247 in Plaque Psoriasis (SPIRIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00244842
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : September 29, 2008
Sponsor:
Information provided by:
Aurinia Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE October 25, 2005
First Posted Date  ICMJE October 27, 2005
Last Update Posted Date September 29, 2008
Study Start Date  ICMJE December 2004
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin. [ Time Frame: Twelve Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of ISA247
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
  • To investigate the safety and tolerability of voclosporin. [ Time Frame: Twelve and twenty four weeks ]
  • To investigate the pharmacokinetics and pharmacodynamics of voclosporin after chronic dosing in a subset of subjects. [ Time Frame: Twelve and twenty four weeks ]
  • To evaluate the effect of voclosporin on subject quality of life [ Time Frame: Twelve and twenty four weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
  • To investigate the safety and tolerability of ISA247
  • To investigate the pharmacokinetics and pharmacodynamics of ISA247 after chronic dosing in a subset of subjects
  • To evaluate the effect of ISA247 on subject quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Placebo-Controlled Study of ISA247 in Plaque Psoriasis
Official Title  ICMJE A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
Brief Summary The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.
Detailed Description

Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile.

Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: voclosporin
    voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Intervention: Drug: voclosporin
  • Active Comparator: 3
    Intervention: Drug: voclosporin
  • Active Comparator: 4
    Intervention: Drug: voclosporin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2008)
451
Original Enrollment  ICMJE
 (submitted: October 25, 2005)
450
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Plaque psoriasis ≥ 6 months prior to screening.
  • Diagnosis of stable, plaque psoriasis; i.e. psoriasis must not be spontaneously improving or worsening in the 4 weeks prior to the screening visit.
  • Plaque psoriasis involving ≥10% of the body surface area (BSA) at screening and prior to randomization at the day 0 visit.
  • PASI score ≥10 at screening and prior to randomization at the day 0 visit.
  • Not pregnant or nursing or planning to become pregnant during the course of the study.
  • Sexually active women of childbearing potential or less than 1 year post-menopausal and sexually active men who are not surgically sterile must use a reliable form of birth control during study treatment and for at least 3 months after the last dose of study drug. Surgically sterile females are not considered to be of childbearing potential. Reliable forms of birth control include oral or depot contraceptives, and double-barrier methods.
  • Written informed consent prior to washout and screening procedures.
  • Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator.

Exclusion Criteria:

  • Has generalized erythrodermic, guttate, or pustular psoriasis.
  • Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the investigator.
  • A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.
  • Has current, uncontrolled bacterial, viral, or fungal infections that require intravenous antibiotics or antifungals or had had such infections within 60 days prior to screening.
  • A history of streptococcal infection that required oral antibiotics within 30 days prior to screening.
  • A known history of tuberculosis.
  • Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus.
  • Uncontrolled hypertension as defined by systolic blood pressure ≥150 mm Hg or diastolic blood pressure ≥ 90 mm Hg.
  • MDRD GFR ≤ 60 ml/min.
  • Variation between the screening and Visit 1 GFR ≥30%.
  • Alanine transaminase, aspartate transaminase, or gamma-glutamyl transferase ≥ 3x upper limit of normal (ULN).
  • White blood cell count ≤ 2.8 x 109/L.
  • Triglycerides ≥ 3x ULN.
  • Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin such as NSAID's or ACE inhibitors, drugs interfering with its pharmacokinetics; drugs considered to contribute to psoriasis flare; or, systemic and topical psoriasis medication (including psoralen/ultraviolet A light treatment) that may interfere with assessment of study drug efficacy.
  • Has used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to the screening visit.
  • Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of the start of treatment. Biological agents include any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
  • Previous exposure to voclosporin.
  • A history of clinically defined allergy to cyclosporine or any of the constituents of the voclosporin formulation (vitamin E, medium chain triglyceride oil, Tween 40, ethanol).
  • A history of alcoholism or drug addiction within 1 year prior to study entry.
  • Weighs <45 kg (99 lbs) or > 140 kg (308 lbs).
  • A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of ISA247 to pose a significant risk to the subject, in the opinion of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00244842
Other Study ID Numbers  ICMJE ISA04-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Huizinga, Isotechnika Inc
Study Sponsor  ICMJE Aurinia Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Bissonnette, MD Innovaderm Research
Principal Investigator: Richard Langley, MD, FRCPC Eastern Canada Cutaneous Research Associates Ltd.
Principal Investigator: Gilles Lauzon, PhD MD FRCPC Western Canada Dermatology Institute
Principal Investigator: Kim Papp, MD, PhD Probity Medical Research
Principal Investigator: Neil Shear, MD Ventana Clinical Research Organization
PRS Account Aurinia Pharmaceuticals Inc.
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP