Chronic Plaque PsoriasisPhase 3NCT00233662
Safety and Tolerability of Repeat Courses of IM Alefacept
A Phase 3 study testing Alefacept in people with Chronic Plaque Psoriasis, run by Biogen at 46 sites in 9 countries.
Trial summary
The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments. 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
- How many people
- 400 participants
- Where
- 46 sitesin 9 countries
- Study dates
- 1 Dec 2002to 1 Dec 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
- Written informed consent.
- At least 16 years of age.
- Diagnosed with chronic plaque psoriasis and require systemic therapy.
- CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
Who cannot join
- Unstable erthrodermic or pustular psoriasis.
- Diagnosis of guttate psoriasis.
- Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
- Positive for HIV antibody.
- Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
- Evidence of active tuberculosis.
Show all 11Show fewer
- Current treatment for active tuberculosis or tuberculosis prophylaxis.
- Female patients unwilling to practice effective contraception as defined by the investigator.
- Female patients who are pregnant or breast-feeding.
- Current enrollment in any other investigational drug study.
- Previous participation in this study or previous alefacept studies.
Trial locations and contacts
46 sites in 9 countries.
46 sites in 9 countries
United States19 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5028
Baylor Dermatology Research Center
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
University of Connecticut Health Center
Farmington, Connecticut, 06430-6231
Rivergate Dermatology
Goodlettsville, Tennessee, 37072-2301
MD Anderson Cancer Center
Houston, Texas, 77030
University of California, Irvine
Irvine, California, 92697
Loyola University Medical Center
Maywood, Illinois, 60153
University of Medicine and Dentistry Robert Wood Jonhson Medical School
New Brunswick, New Jersey, 08903-0019
New York University School of Medicine
New York, New York, 10016
The Mount Sinai School of Medicine
New York, New York, 10029-6547
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
University of Utah School of Medicine
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94118
Clinical Research Specialists, Inc.
Santa Monica, California, 90404
Dermatology Associates
Seattle, Washington, 98101
Central Dermatology
St Louis, Missouri, 63117
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Germany11 sites
Humboldt Universitätsklinikum Charité
Berlin, 10117
St. Josef-Hospital
Bochum, 44791
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Heinrich-Heine-Universität
Düsseldorf, 40225
J W Goethe Universität
Frankfurt, 60590
Klinikum der Albert-Ludwig-Universität
Freiburg im Breisgau, 79104
Universitäts Kliniken
Göttingen, 37075
Universitätskrankenhaus Eppendorf
Hamburg, 20246
Universitätskliniken des Saarlandes
Homburg/Saar, 66421
Universität Mannhein
Mannheim, 68167
Universitätsklinikum Münster
Münster, 48149
Canada5 sites
Western Canada Dermatology Institute
Edmonton, Alberta, T5J 3S9
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, B3H 1Z4
Dermatrials Research
Hamilton, Ontario, L8N 1V6
Royal Victoria Hospital
Montreal, Quebec, H3A1A1
Vancouver Hospital
Vancouver, British Columbia, V5Z 4E8
France4 sites
CHU Henri Mondor
Créteil, 94010
Hopital L'Archet II
Nice, 6202
Hospital Saint Louis, Université Paris VII
Paris, 75475
Hopital Lyon Sud
Pierre-Bénite, 69495
Netherlands2 sites
AMC University of Amsterdam
Amsterdam, 1105 AZ
University Hospital Nijmegen - St. Radboud
Nijmegen, 6500 HB
United Kingdom2 sites
St. John's Institute of Dermatology
London, SE1 7EH
Academic Dermatology
Salford, M6 8HD
About this study
Official title: An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis
The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Alefacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.
Secondary outcomes (1)
Patients who achieve a Physician Global Assessment (PGA) of "almost clear" or "clear" over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study start1 Dec 2002
- Study completion1 Dec 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.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Ticho, MD, Study director, BiogenKenneth Gordon, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233662
- Sponsor's protocol ID
- C-733
- Status last verified
- Aug 2023
- First submitted
- 4 Oct 2005
- Last updated
- 23 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00233662
- Acronym / sponsor ID
- C-733
- Conditions
- Chronic Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2002 (actual)
- Study completion
- 1 Dec 2005 (actual)
- First posted
- 6 Oct 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 whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent.
- At least 16 years of age.
- Diagnosed with chronic plaque psoriasis and require systemic therapy.
- CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
Key exclusion criteria (11 listed)
- Unstable erthrodermic or pustular psoriasis.
- Diagnosis of guttate psoriasis.
- Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
- Positive for HIV antibody.
- Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
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 |
|---|---|---|
| Alefacept | Drug | – |
Primary outcome
Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.
1 secondary outcome
Patients who achieve a Physician Global Assessment (PGA) of "almost clear" or "clear" over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary).
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 23 Aug 2023.
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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.
Barry Ticho, MD study director
Biogen
Kenneth Gordon, MD principal investigator
Loyola University
46 sites in 9 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 Biogen at 46 sites in 9 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 11 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Germany, Canada, France, Netherlands and 4 more countries. 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?
Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.. 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 23 Aug 2023.