Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Randomized, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients (ESSENCE)

This study has been completed.
Sponsor:
Information provided by:
Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00408187
First received: December 4, 2006
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: voclosporin
Drug: Ciclosporin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients

Resource links provided by NLM:


Further study details as provided by Aurinia Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Superiority in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score [ Time Frame: Twelve weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Twelve weeks of treatment ] [ Designated as safety issue: No ]
  • Superiority in de novo hypertriglyceridemia, defined as proportion of patients developing fasting triglycerides greater than or equal to 1.7 mmol/L [ Time Frame: Twenty four weeks of treatment ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: Twenty four weeks of treatment ] [ Designated as safety issue: Yes ]
  • Superiority of renal function, defined as the proportion of patients experiencing a confirmed greater than or equal to 30% rise in serum creatinine [ Time Frame: Twenty four weeks of treatment ] [ Designated as safety issue: Yes ]
  • Superiority in proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI-75) [ Time Frame: Twelve weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 642
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Drug: voclosporin
voclosporin 0.4 mg/kg po BID
Placebo Comparator: 3. Drug: Placebo
Placebo
Active Comparator: 2. Drug: Ciclosporin
ciclosporin 1.5 mg/kg po BID

Detailed Description:

Psoriasis is a chronic skin condition that can have a significant impact on a 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 ciclosporin, 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 ciclosporin A, but also has an improved toxicity profile.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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 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.
  • Previous exposure to voclosporin.
  • A history of clinically defined allergy to ciclosporin, constituents of Neoral or any of the constituents of the ISA247 formulation.
  • A history of alcoholism or drug addiction.
  • Weighs < 45kg (99 lbs).
  • A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, in the evaluation of his/her response or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408187

  Hide Study Locations
Locations
Canada, Alberta
Isotechnika Investigational Site
Edmonton, Alberta, Canada, T5X 1X3
Canada, British Columbia
Isotechnika Investigational Site
Surrey, British Columbia, Canada, V3R 6A7
Isotechnika Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Newfoundland and Labrador
Isotechnika Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 3E1
Isotechnika Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 4F8
Canada, Nova Scotia
Isotechnika Investigational Site
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Isotechnika Investigational Site
Barrie, Ontario, Canada, L4M 6L2
Isotechnika Investigational Site
London, Ontario, Canada, N5X 2P1
Isotechnika Investigational Site
Markham, Ontario, Canada, L3P 1A8
Isotechnika Investigational Site
North Bay, Ontario, Canada, P1B 3Z7
Isotechnika Investigational Site
Ottawa, Ontario, Canada, K2G 6E2
Isotechnika Investigational Site
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Isotechnika Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Isotechnika Investigational Site
Montreal, Quebec, Canada, H3H 1V4
Isotechnika Investigational Site
Quebec City, Quebec, Canada, G1V 4X7
Germany
Isotechnika Investigational Site
Ausburg, Germany, 86179
Isotechnika Investigational Site
Berlin, Germany, 10827
Isotechnika Investigational Site
Berlin, Germany, 10435
Isotechnika Investigational Site
Berlin, Germany, 10437
Isotechnika Investigational Site
Berlin, Germany, 10117
Isotechnika Investigational Site
Bochum, Germany, 44787
Isotechnika Investigational Site
Bochum, Germany, 44791
Isotechnika Investigational Site
Dresden, Germany, 01097
Isotechnika Investigational Site
Dresden, Germany, 01307
Isotechnika Investigational Site
Frankfurt, Germany, 60590
Isotechnika Investigational Site
Geiβen, Germany, 35390
Isotechnika Investigational Site
Hamburg, Germany, 20354
Isotechnika Investigational Site
Hamburg, Germany, 20246
Isotechnika Investigational Site
Kiel, Germany, 24105
Isotechnika Investigational Site
Leipzig, Germany, 04103
Isotechnika Investigational Site
Lubeck, Germany, 23538
Isotechnika Investigational Site
Mahlow, Germany, 15831
Isotechnika Investigational Site
Mainz, Germany, 55131
Isotechnika Investigational Site
Munster, Germany, 48149
Isotechnika Investigational Site
Potsdam, Germany, 14480
Isotechnika Investigational Site
Salzwedel, Germany, 29410
Isotechnika Investigational Site
Wuppertal, Germany, 42275
Poland
Isotechnika Investigational Site
Bialystock, Poland, 15-540
Isotechnika Investigational Site
Bydgoszcz, Poland, 85-096
Isotechnika Investigational Site
Gliwice, Poland, 44-100
Isotechnika Investigational Site
Iwonicz Zdroj, Poland, 38-440
Isotechnika Investigational Site
Krakow, Poland, 31-501
Isotechnika Investigational Site
Lodz, Poland, 91-347
Isotechnika Investigational Site
Lublin, Poland, 02-080
Isotechnika Investigational Site
Poznan, Poland, 60-355
Isotechnika Investigational Site
Szczcin, Poland, 70-111
Isotechnika Investigational Site
Warszawa, Poland, 02-008
Isotechnika Investigational Site
Warzszawa, Poland, 02-008
Isotechnika Investigational Site
Zabrze, Poland, 41-800
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
Investigators
Principal Investigator: Wayne Gulliver, M.D. NewLab Clinical Research
Principal Investigator: Vincent Ho, M.D. UBC
Principal Investigator: Andrzej Langner, Prof. Dr. IWOLANG
Principal Investigator: Thomas A. Luger, Prof. Dr. University of Muenster
Principal Investigator: Slawomir Majewski, Prof. Dr. Akademia Medyczna
Principal Investigator: Wolfram Sterry, Prof. Dr. Charite Universitatsmedizin Berlin
  More Information

Publications:
Responsible Party: Robert Huizinga, Isotechnika
ClinicalTrials.gov Identifier: NCT00408187     History of Changes
Other Study ID Numbers: ISA05-25
Study First Received: December 4, 2006
Last Updated: July 29, 2009
Health Authority: Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Aurinia Pharmaceuticals Inc.:
Randomized Controlled Trials
Immunosuppression
Adult
Chronic Disease
Dermatologic Agents
Female
Humans
Male
Middle Aged
Severity of Illness Index
Treatment Outcome
Quality of Life
Double-Blind Method

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014