Chronic Plaque PsoriasisPhase 3NCT00674063
A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 study testing alefacept in people with Chronic Plaque Psoriasis, run by Astellas Pharma Inc at 17 sites in 2 countries.
Trial summary
Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis Read more about this study
- Who is it for?
- Ages 18 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?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jul 2003to Apr 2004
- 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
- Body weight between 100kg and 150kg
- Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10%
- Candidate for phototherapy or systemic therapy for Psoriasis
- CD4 + T lymphocyte counts > lower limit of normal
Who cannot join
- Clinically significant abnormal hematology values or blood chemistry values
- ALT or AST value of ≥ 3x the upper limit of normal
- Other types of Psoriasis
- Serious infection within 3 months prior to 1st dose of study drug
- Antibody positive for HIV
- History of malignancy
- History of severe allergic or anaphylactic reactions
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States11 sites
Study site
East Windsor, New Jersey, 08520
Study site
Fridley, Minnesota, 55432
Study site
Goodlettsville, Tennessee, 37072
Study site
Hot Springs, Arkansas, 71913
Study site
Johnston, Rhode Island, 02919
Study site
Lake Oswego, Oregon, 97035
Study site
Nashville, Tennessee, 37215
Study site
Norfolk, Virginia, 23507
Study site
Omaha, Nebraska, 68144
Study site
Portland, Oregon, 97210
Study site
Stony Brook, New York, 11790
Canada6 sites
Study site
Hamilton, Ontario, L8N 1V6
Study site
London, Ontario, N6K 1L6
Study site
Moncton, New Brunswick, E1C 8X3
Study site
Montreal, Quebec, H3H 1V4
Study site
Waterloo, Ontario, N2J 1C4
Study site
Windsor, Ontario, N8W 5L7
About this study
Official title: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Weekly Intravenous Administration of 7.5mg and 0.075mg/kg Alefacept in Subjects Weighing Between 100kg and 150kg, With Moderate to Severe Chronic Plaque Psoriasis
Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- alefacept
- 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
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose regimen 1 Receives: Drug: alefacept |
| 2 | Experimental | Dose regimen 2 Receives: Drug: alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline
Measured: 1 Week post treatment
Secondary outcomes (1)
Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline
Measured: 1 Week post treatment
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 startJul 2003
- Primary completionApr 2004
- Study completionApr 2004
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
- 78 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
- NCT00674063
- Sponsor's protocol ID
- C-738
- 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, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Weekly Intravenous Administration of 7.5mg and 0.075mg/kg Alefacept in Subjects Weighing Between 100kg and 150kg, With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00674063
- Acronym / sponsor ID
- C-738
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Chronic Plaque Psoriasis, Alefacept
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Jul 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (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.
Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: alefaceptDose regimen 1 |
| 2 | Experimental | Drug: alefaceptDose regimen 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body weight between 100kg and 150kg
- Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10%
- Candidate for phototherapy or systemic therapy for Psoriasis
- CD4 + T lymphocyte counts > lower limit of normal
Key exclusion criteria (8 listed)
- Clinically significant abnormal hematology values or blood chemistry values
- ALT or AST value of ≥ 3x the upper limit of normal
- Other types of Psoriasis
- Serious infection within 3 months prior to 1st dose of study drug
- Antibody positive for HIV
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, ASP0485IV | Drug | 1, 2 |
Primary outcome
Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline
Time frame: 1 Week post treatment
1 secondary outcome
Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline
Time frame: 1 Week post 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 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.
17 sites in 2 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 17 sites in 2 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 4 inclusion and 8 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 17 sites in United States, 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?
Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline (time frame: 1 Week post treatment). 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.