A 36-Week Extension to Protocol ISA04-03 (SPIRIT)

This study has been completed.
Sponsor:
Information provided by:
Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00258713
First received: November 23, 2005
Last updated: September 24, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: voclosporin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Aurinia Pharmaceuticals Inc.:

Primary Outcome Measures:
  • To investigate long-term safety and tolerability of voclosporin [ Time Frame: Sixty weeks of continuous treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the proportion of subjects achieving and/or maintaining a PASI-75 [ Time Frame: Sixty weeks of continuous treatment ] [ Designated as safety issue: No ]
  • To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA [ Time Frame: Sixty weeks of continuous treatment ] [ Designated as safety issue: No ]
  • To evaluate the effect of voclosporin on subject quality of life [ Time Frame: Sixty weeks of continuous treatment ] [ Designated as safety issue: No ]

Enrollment: 309
Study Start Date: September 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg BID
Active Comparator: 2 Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg BID
Active Comparator: 3 Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg BID

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.

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females aged 18-66 years inclusive at the time of visit 1.
  • Diagnosed with plaque psoriasis ≥ 6 months.
  • Currently participating in study ISA04-03 and completed the study up to and including Visit 9 of study ISA04-03.
  • Not pregnant or nursing of planning to become pregnant during the course of the study
  • Sexually-active women of child-bearing potential (including those who are < 1 year postmenopausal) and sexually-active men who are practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin.
  • Written informed consent prior to any study related 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 infection that requires intravenous antibiotics or antifungals.
  • Has a current streptococcal infection that required oral antibiotics.
  • 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 as 3 readings of systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg.
  • MDRD GFR ≤ 60 mL/min.
  • Unstable renal function (variation in GFR ≥ 30%).
  • Alanine transaminase, aspartate transaminase, or gamma-glutamyl transferase ≥ 3x upper limit of normal(ULN).
  • White blood cell count ≤ 2.8x10 to the ninth power/L.
  • Triglycerides ≥ 3x ULN.
  • Is currently taking or requires the following prohibited medications or treatments during the treatment period: drugs potentiating the nephrotoxicity of voclosporin such as chronic NSAID's or ACE inhibitors, drugs interfering with it's 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 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258713

Locations
Canada, Alberta
Isotechnika Investigational Site
Calgary, Alberta, Canada, T2S 3B3
Isotechnika Investigational Site
Edmonton, Alberta, Canada, T5J 3S9
Canada, British Columbia
Isotechnika Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E8
Isotechnika Investigational Site
Vancouver, British Columbia, Canada, V5Z 3Y1
Canada, Manitoba
Isotechnika Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, New Brunswick
Isotechnika Investigational Site
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Newfoundland and Labrador
Isotechnika Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 3E1
Isotechnika Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 4F8
Canada, Nova Scotia
Isotechnika Investigational Site
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Isotechnika Investigational Site
Barrie, Ontario, Canada, L4M 6L2
Isotechnika Investigational Site
Hamilton, Ontario, Canada, L8N 1V6
Isotechnika Investigational Site
London, Ontario, Canada, N6A 3H7
Isotechnika Investigational Site
London, Ontario, Canada, N5X 2P1
Isotechnika Investigational Site
Maple, Ontario, Canada, L4K 5V2
Isotechnika Investigational Site
Markham, Ontario, Canada, L3P 1A8
Isotechnika Investigational Site
Newmarket, Ontario, Canada, L3Y 6P5
Isotechnika Investigational Site
North Bay, Ontario, Canada, P1B 3Z7
Isotechnika Investigational Site
Oakville, Ontario, Canada, L6K 1E1
Isotechnika Investigational Site
Oshawa, Ontario, Canada, L1H 1B9
Isotechnika Investigational Site
Waterloo, Ontario, Canada, N2J 1C4
Isotechnika Investigational Site
Windsor, Ontario, Canada, N8W 5L7
Isotechnika Investigational Site
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Isotechnika Investigational Site
Laval, Quebec, Canada, H7G 2C6
Isotechnika Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Isotechnika Investigational Site
Montreal, Quebec, Canada, H3H 1V4
Isotechnika Investigational Site
Montreal, Quebec, Canada, H3G 1C6
Isotechnika Investigational Site
Pointe Claire, Quebec, Canada, H9R 4S3
Isotechnika Investigational Site
Saint Foy, Quebec, Canada, G1V 4X7
Isotechnika Investigational Site
Sherbrooke, Quebec, Canada, J1J 2B8
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
Investigators
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 University of Alberta
Principal Investigator: Kim Papp, MD, PhD Probity Medical Research
Principal Investigator: Neil Shear, MD Ventana Clinical Research Corporation
  More Information

Publications:
Responsible Party: Robert Huizinga, Isotechnika
ClinicalTrials.gov Identifier: NCT00258713     History of Changes
Other Study ID Numbers: ISA05-02
Study First Received: November 23, 2005
Last Updated: September 24, 2008
Health Authority: Canada: Health Canada

Keywords provided by Aurinia Pharmaceuticals Inc.:
Randomized Controlled Trials
Immunosuppression
Adult
Chronic Disease
Dermatologic Agents
Female
Humans
Male
Middle Aged
Severity of Illness Index
Treatment Outcome
Quality of Life
Double-Blind Method

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014