A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Psoriasis
- Sponsor
- Aurinia Pharmaceuticals Inc.
- Enrollment
- 451
- Locations
- 2
- Primary Endpoint
- Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.
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.
Investigators
Eligibility 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%.
Arms & Interventions
Placebo Comparator: 1
Placebo
Intervention: Placebo
Voclosporin 0.2 mg/kg po BID
Voclosporin 0.2 mg/kg po BID
Intervention: voclosporin
Voclosporin 0.3 mg/kg po BID
Voclosporin 0.3 mg/kg po BID
Intervention: voclosporin
Voclosporin 0.4 mg/kg po BID
Voclosporin 0.4 mg/kg po BID
Intervention: voclosporin
Outcomes
Primary Outcomes
Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin.
Time Frame: Twelve Weeks
Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin.
Secondary Outcomes
- To Investigate the Safety and Tolerability of Voclosporin.(Twelve and twenty four weeks)
- To Evaluate the Effect of Voclosporin on Subject Quality of Life(Twelve and twenty four weeks)
- To Investigate the Pharmacokinetics and Pharmacodynamics of Voclosporin After Chronic Dosing in a Subset of Subjects.(Twelve and twenty four weeks)