PsoriasisPhase 3SPIRITNCT00258713
A 36-Week Extension to Protocol ISA04-03
A Phase 3 study testing voclosporin in people with Psoriasis, run by Aurinia Pharmaceuticals Inc. at 29 sites in Canada.
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 to 66 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- voclosporin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 29 sitesCanada
- Study dates
- Sep 2005to Jul 2006
- 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 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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 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.
Show all 19Show fewer
- 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.
- A history of clinically defined allergy to cyclosporine or any of the constituents of the voclosporin formulation (vitamin E, medium chain triglyceride oil, Tween 40, ethanol).
- A history of alcoholism or drug addiction within 1 year prior to study entry.
- Weighs < 45 kg (99 lbs) or > 140 kg (308 lbs).
- A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of ISA247 to pose a significant risk to the subject, in the opinion of the investigator.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Canada29 sites
Isotechnika Investigational Site
Barrie, Ontario, L4M 6L2
Isotechnika Investigational Site
Calgary, Alberta, T2S 3B3
Isotechnika Investigational Site
Edmonton, Alberta, T5J 3S9
Isotechnika Investigational Site
Halifax, Nova Scotia, B3H 1Z4
Isotechnika Investigational Site
Hamilton, Ontario, L8N 1V6
Isotechnika Investigational Site
Laval, Quebec, H7G 2C6
Isotechnika Investigational Site
London, Ontario, N5X 2P1
Isotechnika Investigational Site
London, Ontario, N6A 3H7
Isotechnika Investigational Site
Maple, Ontario, L4K 5V2
Isotechnika Investigational Site
Markham, Ontario, L3P 1A8
Isotechnika Investigational Site
Moncton, New Brunswick, E1C 8X3
Isotechnika Investigational Site
Montreal, Quebec, H2K 4L5
Isotechnika Investigational Site
Montreal, Quebec, H3G 1C6
Isotechnika Investigational Site
Montreal, Quebec, H3H 1V4
Isotechnika Investigational Site
Newmarket, Ontario, L3Y 6P5
Isotechnika Investigational Site
North Bay, Ontario, P1B 3Z7
Isotechnika Investigational Site
Oakville, Ontario, L6K 1E1
Isotechnika Investigational Site
Oshawa, Ontario, L1H 1B9
Isotechnika Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Isotechnika Investigational Site
Saint Foy, Quebec, G1V 4X7
Isotechnika Investigational Site
Sherbrooke, Quebec, J1J 2B8
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
Vancouver, British Columbia, V5Z 3Y1
Isotechnika Investigational Site
Vancouver, British Columbia, V5Z 4E8
Isotechnika Investigational Site
Waterloo, Ontario, N2J 1C4
Isotechnika Investigational Site
Windsor, Ontario, N8W 1E6
Isotechnika Investigational Site
Windsor, Ontario, N8W 5L7
Isotechnika Investigational Site
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis
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 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 cyclosporine, 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 cyclosporine A, but also has an improved toxicity profile.
- Conditions
- Psoriasis
- Being tested
- voclosporin
- 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 0.2, 0.3, or 0.4 mg/kg BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: voclosporin |
| 2 | Active comparator | Not described Receives: Drug: voclosporin |
| 3 | Active comparator | Not described Receives: Drug: voclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate long-term safety and tolerability of voclosporin
Measured: Sixty weeks of continuous treatment
Secondary outcomes (3)
To determine the proportion of subjects achieving and/or maintaining a PASI-75
Measured: Sixty weeks of continuous treatment
To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA
Measured: Sixty weeks of continuous treatment
To evaluate the effect of voclosporin on subject quality of life
Measured: Sixty weeks of continuous treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm ResearchRichard Langley, MD, FRCPC, Principal investigator, Eastern Canada Cutaneous Research Associates Ltd.Gilles Lauzon, PhD MD FRCPC, Principal investigator, University of AlbertaKim Papp, MD, PhD, Principal investigator, Probity Medical ResearchNeil Shear, MD, Principal investigator, Ventana Clinical Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258713
- Sponsor's protocol ID
- ISA05-02
- Acronym
- SPIRIT
- Status last verified
- Sep 2008
- First submitted
- 23 Nov 2005
- Last updated
- 29 Sep 2008
- 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 15371668Stalder 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 14672749Abel 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00258713
- Acronym / sponsor ID
- SPIRIT / ISA05-02
- Conditions
- Psoriasis
- Keywords
- Randomized Controlled Trials, Immunosuppression, Adult, Chronic Disease, Dermatologic Agents, Female, Humans, Male
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 28 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.
Detailed description
Psoriasis is a chronic skin condition that can have a significant impact on 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 cyclosporine, 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 cyclosporine A, but also has an improved toxicity profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: voclosporin |
| 2 | Active comparator | Drug: voclosporin |
| 3 | Active comparator | Drug: voclosporin |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| voclosporinvoclosporin 0.2, 0.3, or 0.4 mg/kg BID | Drug | 1, 2, 3 |
Primary outcome
To investigate long-term safety and tolerability of voclosporin
Time frame: Sixty weeks of continuous treatment
3 secondary outcomes
To determine the proportion of subjects achieving and/or maintaining a PASI-75
Time frame: Sixty weeks of continuous treatment
To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA
Time frame: Sixty weeks of continuous treatment
To evaluate the effect of voclosporin on subject quality of life
Time frame: Sixty weeks of continuous treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2008.
- Background: PubMed 15371668Gregory 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.
- Background: PubMed 14672749Stalder 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.
- Background: PubMed 11250240Abel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD principal investigator
Innovaderm Research
Richard Langley, MD, FRCPC principal investigator
Eastern Canada Cutaneous Research Associates Ltd.
Gilles Lauzon, PhD MD FRCPC principal investigator
University of Alberta
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing voclosporin in people with Psoriasis, run by Aurinia Pharmaceuticals Inc. at 29 sites in Canada.
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 7 inclusion and 19 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 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Canada. 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. 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?
To investigate long-term safety and tolerability of voclosporin (time frame: Sixty weeks of continuous 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 NCT00258713, which also lists 3 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 29 Sep 2008.