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

This study has been completed.
Sponsor:
Information provided by:
Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00244842
First received: October 25, 2005
Last updated: September 24, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.


Condition Intervention Phase
Psoriasis
Drug: voclosporin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients

Resource links provided by NLM:


Further study details as provided by Aurinia Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin. [ Time Frame: Twelve Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the safety and tolerability of voclosporin. [ Time Frame: Twelve and twenty four weeks ] [ Designated as safety issue: Yes ]
  • To investigate the pharmacokinetics and pharmacodynamics of voclosporin after chronic dosing in a subset of subjects. [ Time Frame: Twelve and twenty four weeks ] [ Designated as safety issue: No ]
  • To evaluate the effect of voclosporin on subject quality of life [ Time Frame: Twelve and twenty four weeks ] [ Designated as safety issue: No ]

Enrollment: 451
Study Start Date: December 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo
Active Comparator: 2 Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
Active Comparator: 3 Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
Active Comparator: 4 Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg po 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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244842

Locations
Canada, Alberta
Isotechnika Investigational Site
Calgary, Alberta, Canada, T2S 3B3
Isotechnika Investigational Site
Edmonton, Alberta, Canada, T5J 3S9
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
Isotechnika Investigational Site
Victoria, British Columbia, Canada, V8R 6V4
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
Hamilton, Ontario, Canada, L8N 1V6
Isotechnika Investigational Site
London, Ontario, Canada, N5X 2P1
Isotechnika Investigational Site
London, Ontario, Canada, N6A 3H7
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, L4M 6L2
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
Toronto, Ontario, Canada, M5V 2T3
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 2C0
Isotechnika Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Isotechnika Investigational Site
Montreal, Quebec, Canada, H3G 1C6
Isotechnika Investigational Site
Pointe Claire, Quebec, Canada, H9R 4S3
Isotechnika Investigational Site
Sherbrooke, Quebec, Canada, J1J 2B8
Isotechnika Investigational Site
Ste. Foy, Quebec, Canada, G1V 4X7
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 Western Canada Dermatology Institute
Principal Investigator: Kim Papp, MD, PhD Probity Medical Research
Principal Investigator: Neil Shear, MD Ventana Clinical Research Organization
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Huizinga, Isotechnika Inc
ClinicalTrials.gov Identifier: NCT00244842     History of Changes
Other Study ID Numbers: ISA04-03
Study First Received: October 25, 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

ClinicalTrials.gov processed this record on September 22, 2014