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.

Trial Health

On Track

Trial Health Score

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

Enrollment

451

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach

1 country

31 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

December 1, 2004

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed

17.4 years until next milestone

Results Posted

Study results publicly available

March 27, 2023

Completed

Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

October 25, 2005

Results QC Date

January 12, 2018

Last Update Submit

March 23, 2023

Conditions

Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin.
Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin.
Twelve Weeks

Secondary Outcomes (3)

To Investigate the Safety and Tolerability of Voclosporin.
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
To Evaluate the Effect of Voclosporin on Subject Quality of Life
Twelve and twenty four weeks

Study Arms (4)

Placebo Comparator: 1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Voclosporin 0.2 mg/kg po BID

ACTIVE COMPARATOR

Voclosporin 0.2 mg/kg po BID

Drug: voclosporin

Voclosporin 0.3 mg/kg po BID

ACTIVE COMPARATOR

Voclosporin 0.3 mg/kg po BID

Drug: voclosporin

Voclosporin 0.4 mg/kg po BID

ACTIVE COMPARATOR

Voclosporin 0.4 mg/kg po BID

Drug: voclosporin

Interventions

voclosporinDRUG

voclosporin 0.2, 0.3, or 0.4 mg/kg po BID

Voclosporin 0.2 mg/kg po BIDVoclosporin 0.3 mg/kg po BIDVoclosporin 0.4 mg/kg po BID

PlaceboDRUG

Placebo

Placebo Comparator: 1

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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.

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 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%.
Alanine transaminase, aspartate transaminase, or gamma-glutamyl transferase ≥ 3x upper limit of normal (ULN).
White blood cell count ≤ 2.8 x 109/L.
Triglycerides ≥ 3x ULN.
Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin such as NSAID's or ACE inhibitors, drugs interfering with its 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 used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to the screening visit.
+6 more criteria

Contact the study team to confirm eligibility.