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

A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: voclosporin

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.

• Study Type: Interventional
• Enrollment (Actual): 309
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2S 3B3
      • Isotechnika Investigational Site
    • Edmonton, Alberta, Canada, T5J 3S9
      • Isotechnika Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Isotechnika Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 3Y1
      • Isotechnika Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Isotechnika Investigational Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Isotechnika Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3E1
      • Isotechnika Investigational Site
    • St. John's, Newfoundland and Labrador, Canada, A1B 4F8
      • Isotechnika Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z4
      • Isotechnika Investigational Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • 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, 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 1E6
      • Isotechnika Investigational Site
    • Windsor, Ontario, Canada, N8W 5L7
      • Isotechnika Investigational Site
  • Quebec
    • 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
      • Isotechnika Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: voclosporin; voclosporin 0.2, 0.3, or 0.4 mg/kg BID
Active Comparator: 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To investigate long-term safety and tolerability of voclosporin	Sixty weeks of continuous treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the proportion of subjects achieving and/or maintaining a PASI-75	Sixty weeks of continuous treatment
To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA	Sixty weeks of continuous treatment
To evaluate the effect of voclosporin on subject quality of life	Sixty weeks of continuous treatment

Collaborators and Investigators

• Sponsor: Aurinia Pharmaceuticals Inc.
• Investigators: Principal Investigator: Gilles Lauzon, PhD MD FRCPC, University of Alberta; Principal Investigator: Neil Shear, MD, Ventana Clinical Research Corporation

Publications and helpful links

General Publications

• Gregory CR, Kyles AE, Bernsteen L, Wagner GS, Tarantal AF, Christe KL, Brignolo L, Spinner A, Griffey SM, Paniagua RT, Hubble RW, Borie DC, Morris RE. Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model. Transplantation. 2004 Sep 15;78(5):681-5. doi: 10.1097/01.tp.0000131950.75697.71.
• Stalder M, Birsan T, Hubble RW, Paniagua RT, Morris RE. In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates. J Heart Lung Transplant. 2003 Dec;22(12):1343-52. doi: 10.1016/s1053-2498(03)00033-0.
• Abel MD, Aspeslet LJ, Freitag DG, Naicker S, Trepanier DJ, Kneteman NM, Foster RT, Yatscoff RW. ISATX247: a novel calcineurin inhibitor. J Heart Lung Transplant. 2001 Feb;20(2):161. doi: 10.1016/s1053-2498(00)00290-4. No abstract available.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: November 23, 2005
• First Submitted That Met QC Criteria: November 23, 2005
• First Posted (Estimate): November 28, 2005

Study Record Updates

• Last Update Posted (Estimate): September 29, 2008
• Last Update Submitted That Met QC Criteria: September 24, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Humans; Immunosuppression; Quality of Life; Randomized Controlled Trials; Adult; Female; Male; Treatment Outcome; Chronic Disease; Middle Aged; Double-Blind Method; Severity of Illness Index; Dermatologic Agents
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: ISA05-02