Plaque PsoriasisPhase 4NCT00658606

Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects

A Phase 4 study testing alefacept and Narrow Band UVB Phototherapy in people with Plaque Psoriasis, run by Astellas Pharma Inc at 12 sites in Canada.

Completed

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

Official record

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Trial summary

Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Plaque Psoriasis
What is being tested?: alefacept and Narrow Band UVB Phototherapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 12 sitesCanada
Study dates: Oct 2007to Dec 2009
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has given written informed consent
Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10% with a Psoriasis Area and Severity Index (PASI) score >=10 at Baseline
Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal
Male and female subjects must use an adequate means of contraception from screening to end of study.

Who cannot join

Subject who received alefacept in the past
Subject who has shown no improvement following an adequate course of nbUVB in the past
Subject who has been treated in the past with either therapy or cyclosporine
Subject with any active cancer, including skin cancer at Baseline
Subject with erythrodermic, pustular or predominantly guttate psoriasis
Subject who has used treatment for psoriasis prior to Baseline as follows:

Show all 16Show fewer

Topical treatment within 14 days
Oral treatment within 28 days
Broad band UVB (bbUVB) or nbUVB treatment within 56 days
Biological treatment within 84 days
Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug
Subject with a history of drug or alcohol abuse within the past 2 years
Subject that is known to be infected with the AIDS virus
Subject with any other skin disease or other disease that might interfere with psoriasis status assessments
Female subject who is nursing, pregnant or planning to become pregnant while in this study
Subject who is currently enrolled in any other investigational drug or device study

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Canada12 sites

Study site
Calgary, Alberta, T2S 3B3
Study site
London, Ontario, N5X 2P1
Study site
Markham, Ontario, L3P 1A8
Study site
Montreal, Quebec, H2K 4L5
Study site
Montreal, Quebec, H3H 1V4
Study site
Québec, Quebec, G1J 1X7
Study site
Sainte-Foy, Quebec, G1V 4X7
Study site
Saskatoon, Saskatchewan, S7N 0W8
Study site
St. John's, Newfoundland and Labrador, A1C 2H5
Study site
Surrey, British Columbia, V3R 6A7
Study site
Toronto, Ontario, M5S 1B6
Study site
Vancouver, British Columbia, V5Z 4E8

Other trials in Canada

About this study

Official title: Efficacy and Safety of Alefacept in Combination With Narrow-band UVB (nbUVB) Compared to Alefacept Alone in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions: Plaque Psoriasis
Being tested: alefacept, Narrow Band UVB Phototherapy
Keywords: plaque psoriasis, alefacept, Amevive, narrow band ultraviolet B, phototherapy

What participants receive

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

alefaceptDrug
Also called Amevive, ASP0485
IM
Narrow Band UVB PhototherapyProcedure or surgery
UVB Phototherapy

Study groups in NCT00658606
Study group	Role	What they receive
Alefacept alone	Active comparator	15 mg alefacept intramuscularly (IM) once weekly for 12 weeks Receives: Drug: alefacept
Alefacept + nbUVB	Experimental	15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks Receives: Procedure: Narrow Band UVB Phototherapy

What is being measured

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

Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Measured: Week 16

Secondary outcomes (10)

Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Measured: Week 36
Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16
A negative change from Baseline represents improvement.
Change is calculated as Week 16- Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Measured: Baseline and Week 16
Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study
A negative change from Baseline represents improvement.
Change is calculated as Week 36- Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Measured: Baseline and Week 36
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16
The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.
Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.
The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Measured: Week 16
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study
The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.
Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.
The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Measured: Week 36
Percentage of Subjects Who Achieve PASI 90 at Week 16
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
PASI 90 was defined as an improvement of at least 90% in PASI as compared to Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Measured: Week 16
Time to Relapse
The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed.
Relapse is defined by a loss of 50% of improvement in PASI.
Measured: Week 36
Time for 50% Decrease in PASI
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
Only subjects who experienced 50% decrease in PASI were included in the analysis.
Measured: Week 36
Time for a 75% Decrease in PASI
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).
Only subjects who experienced 75% decrease in PASI were included in the analysis.
Measured: Week 36
Change in Dermatology Life Quality Index (DLQI)
The DLQI questionnaire is intended to measure how much a subject's skin problem affects the subject's life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst).
A negative change from Baseline represents improvement.
Change is calculated as Week 36- Baseline.
The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Measured: Baseline and Week 36

Timeline

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

Oct 2007Dec 2009

First posted15 Apr 2008 (estimated)
Study startOct 2007
Primary completionDec 2009
Study completionDec 2009

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 (1)Papers the sponsor has linked to this study.
Other trials for Plaque 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00658606
Sponsor's protocol ID: AME-001
Status last verified: Jan 2013
First submitted: 10 Apr 2008
Last updated: 8 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lui H, Gulliver W, Tan J, Hong CH, Hull P, Shear NH, Paradiso-Hardy F, Bissonette R. A randomized controlled study of combination therapy with alefacept and narrow band UVB phototherapy (UVB) for moderate to severe psoriasis: efficacy, onset, and duration of response. J Drugs Dermatol. 2012 Aug;11(8):929-37.
PubMed 22859237

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

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Alefacept in Combination With Narrow-band UVB (nbUVB) Compared to Alefacept Alone in Subjects With Moderate to Severe Chronic Plaque Psoriasis
ClinicalTrials.gov ID: NCT00658606
Acronym / sponsor ID: AME-001
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis, alefacept, Amevive, narrow band ultraviolet B, phototherapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Collaborators: Astellas Pharma Canada, Inc.
Study start: Oct 2007
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 15 Apr 2008 (estimated)
Results: Posted 22 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Alefacept alone	Active comparator	Drug: alefacept15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
Alefacept + nbUVB	Experimental	Procedure: Narrow Band UVB Phototherapy15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks

Who may qualify

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

Key inclusion criteria (4 listed)

Subject has given written informed consent
Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10% with a Psoriasis Area and Severity Index (PASI) score >=10 at Baseline
Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal
Male and female subjects must use an adequate means of contraception from screening to end of study.

Key exclusion criteria (16 listed)

Subject who received alefacept in the past
Subject who has shown no improvement following an adequate course of nbUVB in the past
Subject who has been treated in the past with either therapy or cyclosporine
Subject with any active cancer, including skin cancer at Baseline
Subject with erythrodermic, pustular or predominantly guttate psoriasis

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
alefaceptAlso: Amevive, ASP0485IM	Drug	Alefacept alone
Narrow Band UVB PhototherapyUVB Phototherapy	Procedure or surgery	Alefacept + nbUVB

Primary outcome

Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
Time frame: Week 16
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.

10 secondary outcomes

Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study
Time frame: Week 36
Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16
Time frame: Baseline and Week 16
Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study
Time frame: Baseline and Week 36
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16
Time frame: Week 16
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study
Time frame: Week 36
Percentage of Subjects Who Achieve PASI 90 at Week 16
Time frame: Week 16
Time to Relapse
Time frame: Week 36
Time for 50% Decrease in PASI
Time frame: Week 36
Time for a 75% Decrease in PASI
Time frame: Week 36
Change in Dermatology Life Quality Index (DLQI)
Time frame: Baseline and Week 36

Results and safety

Results posted to the registry on 22 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alefacept Alone	49	33
Alefacept + nbUVB	49	26

Primary outcome: Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16

Time frame: Week 16. Number. Unit: Percentage of Subjects

Measure	Alefacept Alone n = 49	Alefacept + nbUVB n = 49
Value	22.4	44.9

Alefacept Alone vs Alefacept + nbUVB: p = 0.032, Fisher Exact

Population analysed: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of Informed Consent through the last study visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alefacept Alone	0 of 49 (0%)	10 of 49 (20.4%)	Not reported
Alefacept + nbUVB	2 of 49 (4.1%)	40 of 49 (81.6%)	Not reported

Limitations and caveats (from the sponsor): Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22859237Lui H, Gulliver W, Tan J, Hong CH, Hull P, Shear NH, Paradiso-Hardy F, Bissonette R. A randomized controlled study of combination therapy with alefacept and narrow band UVB phototherapy (UVB) for moderate to severe psoriasis: efficacy, onset, and duration of response. J Drugs Dermatol. 2012 Aug;11(8):929-37.
Link to Prescribing InformationLink provided by the sponsor.

Related trials for Plaque Psoriasis

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

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.

Use Central Contact study director

Astellas Pharma Canada, Inc.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing alefacept and Narrow Band UVB Phototherapy in people with Plaque Psoriasis, run by Astellas Pharma Inc at 12 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 4 inclusion and 16 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 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 22 Apr 2011). 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?

Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16 (time frame: Week 16). 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 NCT00658606, which also lists 1 linked publication.

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 8 Jan 2013.