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

309

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Sep 2005

Shorter than P25 for phase_3

Geographic Reach

1 country

29 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

10 months study duration

Study Start

First participant enrolled

September 1, 2005

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2005

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed

Last Updated

September 29, 2008

Status Verified

September 1, 2008

Enrollment Period

10 months

First QC Date

November 23, 2005

Last Update Submit

September 24, 2008

Conditions

Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

To investigate long-term safety and tolerability of voclosporin
Sixty weeks of continuous treatment

Secondary Outcomes (3)

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

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: voclosporin

2

ACTIVE COMPARATOR

Drug: voclosporin

3

ACTIVE COMPARATOR

Drug: voclosporin

Interventions

voclosporinDRUG

voclosporin 0.2, 0.3, or 0.4 mg/kg BID

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Eligibility Criteria

Age18 Years - 66 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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.

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 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.
+4 more criteria

Contact the study team to confirm eligibility.