PsoriasisPhase 3SPIRITNCT00244842

Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis

A Phase 3 study testing voclosporin in people with Psoriasis, run by Aurinia Pharmaceuticals Inc. at 31 sites in Canada.

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 which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Psoriasis
What is being tested?: voclosporin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 451 participants
Where: 31 sitesCanada
Study dates: Dec 2004to Oct 2005
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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 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.

Show all 21Show fewer

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.
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.
Previous exposure to voclosporin.
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

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

Canada31 sites

Isotechnika Investigational Site
Calgary, Alberta, T2S 3B3
Isotechnika Investigational Site'
Edmonton, Alberta, T5J 3S9
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 2C0
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
Newmarket, Ontario, L3Y 6P5
Isotechnika Investigational Site
North Bay, Ontario, L4M 6L2
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
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
Ste. Foy, Quebec, G1V 4X7
Isotechnika Investigational Site
Toronto, Ontario, M5V 2T3
Isotechnika Investigational Site
Vancouver, British Columbia, V5Z 3Y1
Isotechnika Investigational Site
Vancouver, British Columbia, V5Z 4E8
Isotechnika Investigational Site
Victoria, British Columbia, V8R 6V4
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

Other trials in Canada

About this study

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

The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.

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.

Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo.

Conditions: Psoriasis
Being tested: voclosporin, 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 0.2, 0.3, or 0.4 mg/kg po BID
PlaceboDrug
Placebo

Study groups in NCT00244842
Study group	Role	What they receive
Placebo Comparator: 1	Placebo comparator	Placebo Receives: Drug: Placebo
Voclosporin 0.2 mg/kg po BID	Active comparator	Voclosporin 0.2 mg/kg po BID Receives: Drug: voclosporin
Voclosporin 0.3 mg/kg po BID	Active comparator	Voclosporin 0.3 mg/kg po BID Receives: Drug: voclosporin
Voclosporin 0.4 mg/kg po BID	Active comparator	Voclosporin 0.4 mg/kg po BID Receives: Drug: voclosporin

What is being measured

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

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.
Measured: Twelve Weeks

Secondary outcomes (3)

To Investigate the Safety and Tolerability of Voclosporin.
Measured: Twelve and twenty four weeks
To Investigate the Pharmacokinetics and Pharmacodynamics of Voclosporin After Chronic Dosing in a Subset of Subjects.
Measured: Twelve and twenty four weeks
To Evaluate the Effect of Voclosporin on Subject Quality of Life
Measured: Twelve and twenty four weeks

Timeline

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

Dec 2004Oct 2005

First posted27 Oct 2005 (estimated)
Study startDec 2004
Primary completionOct 2005
Study completionOct 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)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: 451 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00244842
Sponsor's protocol ID: ISA04-03
Acronym: SPIRIT
Status last verified: Mar 2023
First submitted: 25 Oct 2005
Last updated: 27 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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
Papp K, Bissonnette R, Rosoph L, Wasel N, Lynde CW, Searles G, Shear NH, Huizinga RB, Maksymowych WP. Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study. Lancet. 2008 Apr 19;371(9621):1337-42. doi: 10.1016/S0140-6736(08)60593-0.
PubMed 18424323

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
ClinicalTrials.gov ID: NCT00244842
Acronym / sponsor ID: SPIRIT / ISA04-03
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: 451 participants (actual)
Lead sponsor: Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Oct 2005 (actual)
Study completion: Oct 2005 (actual)
First posted: 27 Oct 2005 (estimated)
Results: Posted 27 Mar 2023

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 which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.

Detailed description

Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo Comparator: 1	Placebo comparator	Drug: PlaceboPlacebo
Voclosporin 0.2 mg/kg po BID	Active comparator	Drug: voclosporinVoclosporin 0.2 mg/kg po BID
Voclosporin 0.3 mg/kg po BID	Active comparator	Drug: voclosporinVoclosporin 0.3 mg/kg po BID
Voclosporin 0.4 mg/kg po BID	Active comparator	Drug: voclosporinVoclosporin 0.4 mg/kg po BID

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (21 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 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.

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 po BID	Drug	Voclosporin 0.2 mg/kg po BID, Voclosporin 0.3 mg/kg po BID, Voclosporin 0.4 mg/kg po BID
PlaceboPlacebo	Drug	Placebo Comparator: 1

Primary outcome

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

3 secondary outcomes

To Investigate the Safety and Tolerability of Voclosporin.
Time frame: Twelve and twenty four weeks
To Investigate the Pharmacokinetics and Pharmacodynamics of Voclosporin After Chronic Dosing in a Subset of Subjects.
Time frame: Twelve and twenty four weeks
To Evaluate the Effect of Voclosporin on Subject Quality of Life
Time frame: Twelve and twenty four weeks

Results and safety

Results posted to the registry on 27 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo 1	115	92
ISA247 2	107	76
ISA247 3	113	91
ISA247 4	116	83

Primary outcome: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin.

Time frame: Twelve Weeks. Count of participants. Unit: Participants

Measure	Placebo n = 113	Voclosporin 0.2 n = 105	Voclosporin 0.3 n = 111	Voclosporin 0.4 n = 113
Value	4	14	26	44

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 115 (3.5%)	62 of 115 (53.9%)	1 of 115
Voclosporin 0.2	2 of 107 (1.9%)	67 of 107 (62.6%)	0 of 107
Voclosporin 0.3	4 of 113 (3.5%)	65 of 113 (57.5%)	1 of 113
Voclosporin 0.4	1 of 116 (0.9%)	80 of 116 (69%)	0 of 116

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Derived from this study: PubMed 18424323Papp K, Bissonnette R, Rosoph L, Wasel N, Lynde CW, Searles G, Shear NH, Huizinga RB, Maksymowych WP. Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study. Lancet. 2008 Apr 19;371(9621):1337-42. doi: 10.1016/S0140-6736(08)60593-0.
Individual participant dataSharing planned: No

Related trials for Psoriasis

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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

Western Canada Dermatology Institute

31 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 31 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 8 inclusion and 21 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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. 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?

Yes. Results are posted in the registry (first posted 27 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (time frame: Twelve Weeks). 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 NCT00244842, 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 27 Mar 2023.