- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00258713
A 36-Week Extension to Protocol ISA04-03 (SPIRIT)
September 24, 2008 updated by: Aurinia Pharmaceuticals Inc.
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2S 3B3
- Isotechnika Investigational Site
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Edmonton, Alberta, Canada, T5J 3S9
- Isotechnika Investigational Site
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E8
- Isotechnika Investigational Site
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Vancouver, British Columbia, Canada, V5Z 3Y1
- Isotechnika Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
- Isotechnika Investigational Site
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
- Isotechnika Investigational Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3E1
- Isotechnika Investigational Site
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St. John's, Newfoundland and Labrador, Canada, A1B 4F8
- Isotechnika Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1Z4
- Isotechnika Investigational Site
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Ontario
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Barrie, Ontario, Canada, L4M 6L2
- Isotechnika Investigational Site
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Hamilton, Ontario, Canada, L8N 1V6
- Isotechnika Investigational Site
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London, Ontario, Canada, N5X 2P1
- Isotechnika Investigational Site
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London, Ontario, Canada, N6A 3H7
- Isotechnika Investigational Site
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Maple, Ontario, Canada, L4K 5V2
- Isotechnika Investigational Site
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Markham, Ontario, Canada, L3P 1A8
- Isotechnika Investigational Site
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Newmarket, Ontario, Canada, L3Y 6P5
- Isotechnika Investigational Site
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North Bay, Ontario, Canada, P1B 3Z7
- Isotechnika Investigational Site
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Oakville, Ontario, Canada, L6K 1E1
- Isotechnika Investigational Site
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Oshawa, Ontario, Canada, L1H 1B9
- Isotechnika Investigational Site
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Waterloo, Ontario, Canada, N2J 1C4
- Isotechnika Investigational Site
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Windsor, Ontario, Canada, N8W 1E6
- Isotechnika Investigational Site
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Windsor, Ontario, Canada, N8W 5L7
- Isotechnika Investigational Site
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Quebec
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Laval, Quebec, Canada, H7G 2C6
- Isotechnika Investigational Site
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Montreal, Quebec, Canada, H2K 4L5
- Isotechnika Investigational Site
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Montreal, Quebec, Canada, H3H 1V4
- Isotechnika Investigational Site
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Montreal, Quebec, Canada, H3G 1C6
- Isotechnika Investigational Site
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Pointe Claire, Quebec, Canada, H9R 4S3
- Isotechnika Investigational Site
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Saint Foy, Quebec, Canada, G1V 4X7
- Isotechnika Investigational Site
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Sherbrooke, Quebec, Canada, J1J 2B8
- Isotechnika Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 2
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voclosporin 0.2, 0.3, or 0.4 mg/kg BID
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Active Comparator: 1
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voclosporin 0.2, 0.3, or 0.4 mg/kg BID
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Active Comparator: 3
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voclosporin 0.2, 0.3, or 0.4 mg/kg BID
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To investigate long-term safety and tolerability of voclosporin
Time Frame: Sixty weeks of continuous treatment
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Sixty weeks of continuous treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To determine the proportion of subjects achieving and/or maintaining a PASI-75
Time Frame: Sixty weeks of continuous treatment
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Sixty weeks of continuous treatment
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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
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Sixty weeks of continuous treatment
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To evaluate the effect of voclosporin on subject quality of life
Time Frame: Sixty weeks of continuous treatment
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Sixty weeks of continuous treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gilles Lauzon, PhD MD FRCPC, University of Alberta
- Principal Investigator: Neil Shear, MD, Ventana Clinical Research Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISA05-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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