Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

642

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2006

Geographic Reach

3 countries

49 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

December 1, 2006

Completed

3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2006

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed

Last Updated

July 30, 2009

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

December 4, 2006

Last Update Submit

July 29, 2009

Conditions

Psoriasis

Keywords

Randomized Controlled TrialsImmunosuppressionAdultChronic DiseaseDermatologic AgentsFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeQuality of LifeDouble-Blind Method

Outcome Measures

Primary Outcomes (1)

Superiority in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score
Twelve weeks of treatment

Secondary Outcomes (5)

To show non-inferiority of voclosporin compared to ciclosporin in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score at
Twelve weeks of treatment
Superiority in de novo hypertriglyceridemia, defined as proportion of patients developing fasting triglycerides greater than or equal to 1.7 mmol/L
Twenty four weeks of treatment
Superiority in de novo hypertension, defined as proportion of patients developing blood pressure greater than or equal to 140 mmHg (systolic) or greater than or equal to 90 mmHg (diastolic)
Twenty four weeks of treatment
Superiority of renal function, defined as the proportion of patients experiencing a confirmed greater than or equal to 30% rise in serum creatinine
Twenty four weeks of treatment
Superiority in proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI-75)
Twelve weeks of treatment

Study Arms (3)

1.

ACTIVE COMPARATOR

Drug: voclosporin

3.

PLACEBO COMPARATOR

Drug: Placebo

2.

ACTIVE COMPARATOR

Drug: Ciclosporin

Interventions

voclosporinDRUG

voclosporin 0.4 mg/kg po BID

CiclosporinDRUG

ciclosporin 1.5 mg/kg po BID

PlaceboDRUG

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged greater than or equal to 18 years of age inclusive at time of screening.
Diagnosed with plaque psoriasis greater than or equal to 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.
Psoriasis failing at least one systemic treatment regimen or where other systemic therapies are contraindicated or where tolerability is an issue.
Plaque psoriasis involving greater than or equal to 10% of the body surface area and a SPGA score greater than or equal to 3 at screening and prior to randomization at the day 0 visit.
Not pregnant or nursing.
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.

You may not qualify if:

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 a current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals or has had such infections within 60 days prior to screening.
A known history of tuberculosis.
Serologic evidence or known latent HIV, HBV or HCV virus.
Uncontrolled hypertension of systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 90 mmHg.
MDRD GFR \< 60 mL/min.
Variation between the screening and Visit 1 SCr greater than or equal to 30%.
ALT, AST, GGT greater than or equal to 2x upper limit of normal (ULN).
White blood cell count less than or equal to 2.8 x 10 to the ninth power/L.
Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin, drugs interfering with its pharmacokinetics, drugs considered to contribute to psoriasis flare; or, systemic and topical psoriasis medication that may interfere with assessment of study drug efficacy.
Has used any investigational drug or device within 30 days or 10 half lives (whichever is longer) prior to the screening visit.
Current participation in another clinical trial of any drug or biological agent.
Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of randomization. Biological agents include any virus, live vaccine, therapeutic serum, toxin, antitoxin, monoclonal antibodies or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
+5 more criteria

Contact the study team to confirm eligibility.