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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
voclosporin
Sponsored by
Aurinia Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring 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

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site
  • Isotechnika Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

To investigate long-term safety and tolerability of voclosporin

Secondary Outcome Measures

To determine the proportion of subjects achieving and/or maintaining a PASI-75
To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA
To evaluate the effect of voclosporin on subject quality of life

Full Information

First Posted
November 23, 2005
Last Updated
September 24, 2008
Sponsor
Aurinia Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00258713
Brief Title
A 36-Week Extension to Protocol ISA04-03
Acronym
SPIRIT
Official Title
A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aurinia Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
voclosporin
Intervention Description
voclosporin 0.2, 0.3, or 0.4 mg/kg BID
Primary Outcome Measure Information:
Title
To investigate long-term safety and tolerability of voclosporin
Time Frame
Sixty weeks of continuous treatment
Secondary Outcome Measure Information:
Title
To determine the proportion of subjects achieving and/or maintaining a PASI-75
Time Frame
Sixty weeks of continuous treatment
Title
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
Title
To evaluate the effect of voclosporin on subject quality of life
Time Frame
Sixty weeks of continuous treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD
Organizational Affiliation
Innovaderm Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Langley, MD, FRCPC
Organizational Affiliation
Eastern Canada Cutaneous Research Associates Ltd.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilles Lauzon, PhD MD FRCPC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kim Papp, MD, PhD
Organizational Affiliation
Probity Medical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil Shear, MD
Organizational Affiliation
Ventana Clinical Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isotechnika Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3B3
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3Y1
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Isotechnika Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Isotechnika Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 4F8
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z4
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
Isotechnika Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
Facility Name
Isotechnika Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Maple
State/Province
Ontario
ZIP/Postal Code
L4K 5V2
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 6P5
Country
Canada
Facility Name
Isotechnika Investigational Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6K 1E1
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7G 2C6
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1C6
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Saint Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Isotechnika Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2B8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15371668
Citation
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.
Results Reference
background
PubMed Identifier
14672749
Citation
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.
Results Reference
background
PubMed Identifier
11250240
Citation
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.
Results Reference
background

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A 36-Week Extension to Protocol ISA04-03

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