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PsoriasisPhase 3ESSENCENCT00408187

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

A Phase 3 study testing voclosporin and Ciclosporin in people with Psoriasis, run by Aurinia Pharmaceuticals Inc. at 49 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
voclosporin and Ciclosporin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
642 participants
Where
49 sitesin 3 countries
Study dates
Dec 2006to Dec 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

49 sites in 3 countries.

49 sites in 3 countries

Germany22 sites

  • Isotechnika Investigational Site

    Ausburg, 86179

  • Isotechnika Investigational Site

    Berlin, 10117

  • Isotechnika Investigational Site

    Berlin, 10435

  • Isotechnika Investigational Site

    Berlin, 10437

  • Isotechnika Investigational Site

    Berlin, 10827

  • Isotechnika Investigational Site

    Bochum, 44787

  • Isotechnika Investigational Site

    Bochum, 44791

  • Isotechnika Investigational Site

    Dresden, 01097

  • Isotechnika Investigational Site

    Dresden, 01307

  • Isotechnika Investigational Site

    Frankfurt, 60590

  • Isotechnika Investigational Site

    Geiβen, 35390

  • Isotechnika Investigational Site

    Hamburg, 20246

  • Isotechnika Investigational Site

    Hamburg, 20354

  • Isotechnika Investigational Site

    Hansestadt Salzwedel, 29410

  • Isotechnika Investigational Site

    Kiel, 24105

  • Isotechnika Investigational Site

    Leipzig, 04103

  • Isotechnika Investigational Site

    Lübeck, 23538

  • Isotechnika Investigational Site

    Mahlow, 15831

  • Isotechnika Investigational Site

    Mainz, 55131

  • Isotechnika Investigational Site

    Münster, 48149

  • Isotechnika Investigational Site

    Potsdam, 14480

  • Isotechnika Investigational Site

    Wuppertal, 42275

Other trials in Germany

Canada15 sites

  • Isotechnika Investigational Site

    Barrie, Ontario, L4M 6L2

  • Isotechnika Investigational Site

    Edmonton, Alberta, T5X 1X3

  • Isotechnika Investigational Site

    Halifax, Nova Scotia, B3H 1Z4

  • Isotechnika Investigational Site

    London, Ontario, N5X 2P1

  • Isotechnika Investigational Site

    Markham, Ontario, L3P 1A8

  • Isotechnika Investigational Site

    Montreal, Quebec, H2K 4L5

  • Isotechnika Investigational Site

    Montreal, Quebec, H3H 1V4

  • Isotechnika Investigational Site

    North Bay, Ontario, P1B 3Z7

  • Isotechnika Investigational Site

    Ottawa, Ontario, K2G 6E2

  • Isotechnika Investigational Site

    Québec, Quebec, G1V 4X7

  • Isotechnika Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3E1

  • Isotechnika Investigational Site

    St. John's, Newfoundland and Labrador, A1B 4F8

  • Isotechnika Investigational Site

    Surrey, British Columbia, V3R 6A7

  • Isotechnika Investigational Site

    Vancouver, British Columbia, V5Z 4E8

  • Isotechnika Investigational Site

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Poland12 sites

  • Isotechnika Investigational Site

    Bialystock, 15-540

  • Isotechnika Investigational Site

    Bydgoszcz, 85-096

  • Isotechnika Investigational Site

    Gliwice, 44-100

  • Isotechnika Investigational Site

    Iwonicz-Zdrój, 38-440

  • Isotechnika Investigational Site

    Krakow, 31-501

  • Isotechnika Investigational Site

    Lodz, 91-347

  • Isotechnika Investigational Site

    Lublin, 02-080

  • Isotechnika Investigational Site

    Poznan, 60-355

  • Isotechnika Investigational Site

    Szczcin, 70-111

  • Isotechnika Investigational Site

    Warsaw, 02-008

  • Isotechnika Investigational Site

    Warzszawa, 02-008

  • Isotechnika Investigational Site

    Zabrze, 41-800

Other trials in Poland

About this study

Official title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients

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

Read the 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.

Conditions
Psoriasis
Being tested
voclosporin, Ciclosporin, Placebo
Keywords
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
Medical subject headings
Psoriasis, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • voclosporinDrug

    voclosporin 0.4 mg/kg po BID

  • CiclosporinDrug

    ciclosporin 1.5 mg/kg po BID

  • PlaceboDrug

    Placebo

Study groups in NCT00408187
Study groupRoleWhat they receive
1.Active comparatorNot described
Receives: Drug: voclosporin
3.Placebo comparatorNot described
Receives: Drug: Placebo
2.Active comparatorNot described
Receives: Drug: Ciclosporin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Twelve weeks of treatment

Secondary outcomes (5)

  1. 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

    Measured: Twelve weeks of treatment

  2. Superiority in de novo hypertriglyceridemia, defined as proportion of patients developing fasting triglycerides greater than or equal to 1.7 mmol/L

    Measured: Twenty four weeks of treatment

  3. 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)

    Measured: Twenty four weeks of treatment

  4. Superiority of renal function, defined as the proportion of patients experiencing a confirmed greater than or equal to 30% rise in serum creatinine

    Measured: Twenty four weeks of treatment

  5. Superiority in proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI-75)

    Measured: Twelve weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00408187
Sponsor's protocol ID
ISA05-25
Acronym
ESSENCE
Status last verified
Jul 2009
First submitted
4 Dec 2006
Last updated
30 Jul 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Gregory CR, Kyles AE, Bernsteen L, Wagner GS, Tarantal AF, Christe KL, Brignolo L, Spinner A, Griffey SM, Paniagua RT, Hubble RW, Borie DC, Morris RE. Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model. Transplantation. 2004 Sep 15;78(5):681-5. doi: 10.1097/01.tp.0000131950.75697.71.

    PubMed 15371668

  • Stalder M, Birsan T, Hubble RW, Paniagua RT, Morris RE. In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates. J Heart Lung Transplant. 2003 Dec;22(12):1343-52. doi: 10.1016/s1053-2498(03)00033-0.

    PubMed 14672749

  • Abel MD, Aspeslet LJ, Freitag DG, Naicker S, Trepanier DJ, Kneteman NM, Foster RT, Yatscoff RW. ISATX247: a novel calcineurin inhibitor. J Heart Lung Transplant. 2001 Feb;20(2):161. doi: 10.1016/s1053-2498(00)00290-4. No abstract available.

    PubMed 11250240

  • Bissonnette R, Papp K, Poulin Y, Lauzon G, Aspeslet L, Huizinga R, Mayo P, Foster RT, Yatscoff RW, Maksymowych WP; ISA247 Psoriasis Study Group. A randomized, multicenter, double-blind, placebo-controlled phase 2 trial of ISA247 in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2006 Mar;54(3):472-8. doi: 10.1016/j.jaad.2005.10.061. Epub 2006 Jan 23.

    PubMed 16488299

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing voclosporin and Ciclosporin in people with Psoriasis, run by Aurinia Pharmaceuticals Inc. at 49 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Germany, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00408187, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2009.

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