Chronic Plaque PsoriasisPhase 3NCT00673556
A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
A Phase 3 study testing alefacept in people with Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 34 sites in 5 countries.
Trial summary
To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- alefacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 34 sitesin 5 countries
- Study dates
- Oct 2003to May 2005
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area
- Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective
- CD4+ T lymphocyte counts at or above the lower limit of normal
Who cannot join
- Clinically significant abnormal hematology values or blood chemistry values
- AST or ALT ≥ 3x the upper limit of normal
- Other types of Psoriasis
- Serious infection within the 3 months prior to the first dose of study drug
- History of drug or alcohol abuse within the past 2 years
- Antibody positive for HIV
Show all 13Show fewer
- History of malignancy
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
- Exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug
- Exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical CNIs within 4 weeks prior to the first dose of study drug
- Current treatment with any therapy for tuberculosis
- Previous exposure to Alefacept
- Nursing mothers, pregnant women, and women planning to become pregnant during the study
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
Germany11 sites
Study site
Bochum, 44791
Study site
Dresden, 01307
Study site
Düsseldorf, 40225
Study site
Essen, 45147
Study site
Frankfurt, 60596
Study site
Göttingen, 37075
Study site
Hamburg, 20246
Study site
Hanover, 30449
Study site
Homburg-Saar, 66421
Study site
Mannheim, 68135
Study site
Münster, 48149
United States10 sites
Study site
Dallas, Texas, 75246
Study site
Goodlettsville, Tennessee, 37072
Study site
Irvine, California, 92697
Study site
New Brunswick, New Jersey, 08903
Study site
Norfolk, Virginia, 23507
Study site
Omaha, Nebraska, 68144
Study site
Salt Lake City, Utah, 84132
Study site
Santa Monica, California, 90404
Study site
Seattle, Washington, 98104
Study site
Winston-Salem, North Carolina, 27157
Canada9 sites
Study site
Concord, Ontario, L4K 5V2
Study site
Edmonton, Alberta, T5J 3S9
Study site
Halifax, Nova Scotia, B3H 1Z4
Study site
Hamilton, Ontario, L8N 1V6
Study site
London, Ontario, N6K 1L6
Study site
Montreal, Quebec, H2K 4L5
Study site
Sainte-Foy, Quebec, G1V 4X7
Study site
St. John's, Newfoundland and Labrador, A1B 4S8
Study site
Windsor, Ontario, N8W 5L7
Belgium3 sites
Study site
Brussels, 1070
Study site
Edegem, 2650
Study site
Liège, 4020
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study Examining the Efficacy and Safety of Weekly Intramuscular Administration of 15mg Alefacept Over 12 Weeks in a Population of Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate
Read the detailed description
Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- alefacept, placebo
- Keywords
- Chronic Plaque Psoriasis, Alefacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alefaceptDrug
Also called Amevive, ASP0485
Intramuscular (IM)
placeboDrug
Intramuscular (IM)
| Study group | Role | What they receive |
|---|---|---|
| Course A1 | Experimental | Not described Receives: Drug: alefacept |
| Course A2 | Placebo comparator | Not described Receives: Drug: placebo |
| Course B | Experimental | Open label extension Receives: Drug: alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50
Measured: 14 Weeks
Secondary outcomes (2)
Proportion of patients achieving a PASI score of ≥ 50 any time during study
Measured: Throughout study
Proportion of patients achieving a PASI score of ≥ 75
Measured: 14 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startOct 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Use central contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673556
- Sponsor's protocol ID
- C-740
- Status last verified
- Aug 2014
- First submitted
- 6 May 2008
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study Examining the Efficacy and Safety of Weekly Intramuscular Administration of 15mg Alefacept Over 12 Weeks in a Population of Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
- ClinicalTrials.gov ID
- NCT00673556
- Acronym / sponsor ID
- C-740
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Chronic Plaque Psoriasis, Alefacept
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Oct 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 7 May 2008 (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.
To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate
Detailed description
Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Course A1 | Experimental | Drug: alefacept |
| Course A2 | Placebo comparator | Drug: placebo |
| Course B | Experimental | Drug: alefaceptOpen label extension |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area
- Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective
- CD4+ T lymphocyte counts at or above the lower limit of normal
Key exclusion criteria (13 listed)
- Clinically significant abnormal hematology values or blood chemistry values
- AST or ALT ≥ 3x the upper limit of normal
- Other types of Psoriasis
- Serious infection within the 3 months prior to the first dose of study drug
- History of drug or alcohol abuse within the past 2 years
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, ASP0485Intramuscular (IM) | Drug | Course A1, Course B |
| placeboIntramuscular (IM) | Drug | Course A2 |
Primary outcome
Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50
Time frame: 14 Weeks
2 secondary outcomes
Proportion of patients achieving a PASI score of ≥ 50 any time during study
Time frame: Throughout study
Proportion of patients achieving a PASI score of ≥ 75
Time frame: 14 Weeks
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 26 Aug 2014.
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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.
Use central contact study director
Astellas Pharma US, Inc.
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alefacept in people with Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 34 sites in 5 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 3 inclusion and 13 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 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany, United States, Canada, Belgium, Austria. 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?
Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50 (time frame: 14 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2014.