A 36-Week Extension to Protocol ISA04-03

Psoriasis Clinical Trial

— SPIRIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258713
• Other study ID #: ISA05-02
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2005
• Last updated: September 24, 2008
• Start date: September 2005
• Est. completion date: July 2006

Study information

• Verified date: September 2008
• Source: Aurinia Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg BID

Locations

Country	Name	City	State
Canada	Isotechnika Investigational Site	Barrie	Ontario
Canada	Isotechnika Investigational Site	Calgary	Alberta
Canada	Isotechnika Investigational Site	Edmonton	Alberta
Canada	Isotechnika Investigational Site	Halifax	Nova Scotia
Canada	Isotechnika Investigational Site	Hamilton	Ontario
Canada	Isotechnika Investigational Site	Laval	Quebec
Canada	Isotechnika Investigational Site	London	Ontario
Canada	Isotechnika Investigational Site	London	Ontario
Canada	Isotechnika Investigational Site	Maple	Ontario
Canada	Isotechnika Investigational Site	Markham	Ontario
Canada	Isotechnika Investigational Site	Moncton	New Brunswick
Canada	Isotechnika Investigational Site	Montreal	Quebec
Canada	Isotechnika Investigational Site	Montreal	Quebec
Canada	Isotechnika Investigational Site	Montreal	Quebec
Canada	Isotechnika Investigational Site	Newmarket	Ontario
Canada	Isotechnika Investigational Site	North Bay	Ontario
Canada	Isotechnika Investigational Site	Oakville	Ontario
Canada	Isotechnika Investigational Site	Oshawa	Ontario
Canada	Isotechnika Investigational Site	Pointe Claire	Quebec
Canada	Isotechnika Investigational Site	Saint Foy	Quebec
Canada	Isotechnika Investigational Site	Sherbrooke	Quebec
Canada	Isotechnika Investigational Site	St. John's	Newfoundland and Labrador
Canada	Isotechnika Investigational Site	St. John's	Newfoundland and Labrador
Canada	Isotechnika Investigational Site	Vancouver	British Columbia
Canada	Isotechnika Investigational Site	Vancouver	British Columbia
Canada	Isotechnika Investigational Site	Waterloo	Ontario
Canada	Isotechnika Investigational Site	Windsor	Ontario
Canada	Isotechnika Investigational Site	Windsor	Ontario
Canada	Isotechnika Investigational Site	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Aurinia Pharmaceuticals Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View Citation

Stalder M, Bîrsan 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate long-term safety and tolerability of voclosporin		Sixty weeks of continuous treatment	Yes
Secondary	To determine the proportion of subjects achieving and/or maintaining a PASI-75		Sixty weeks of continuous treatment	No
Secondary	To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA		Sixty weeks of continuous treatment	No
Secondary	To evaluate the effect of voclosporin on subject quality of life		Sixty weeks of continuous treatment	No