Chronic Plaque PsoriasisPhase 4NCT00794807
Safety and Tolerability of Repeat Courses of IM Alefacept
A Phase 4 study testing Alefacept in people with Chronic Plaque Psoriasis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larger studies, as well as the FDA-approved labeling, is confined to treatment courses of 12 weeks. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2004to Dec 2005
- Phase
- Phase 4
- 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
- Must give written informed consent.
- Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1.
Who cannot join
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
- Serious local infection (e.g., abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
- Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3.
- Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
- Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
- Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration.
- Known HIV+, known viral Hepatitis infection, known tuberculosis infection.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psoriasis Study center, The interdisciplinary group of Molecular Immunopathology
Berlin, State of Berlin, 10117
About this study
Official title: A 12-Week Open-Label Followed by 4-Week Double-Blind Study to Determine the Safety and Efficacy of an Extended Course of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis
Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larger studies, as well as the FDA-approved labeling, is confined to treatment courses of 12 weeks. The purpose of the present study is to offer an extended course of therapy with alefacept.
Read the detailed description
Twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (PASI: 7-36) were included in this study. They were treated with 15 mg alefacept i.m. weekly. Peripheral blood was taken prior to first alefacept application and then weekly until week five and thereafter every second week, until the end of treatment at week 13. At the same time points severity of disease and thereby possible reduction of symptoms was evaluated applying the PASI. Investigators analysing the samples were blinded to the outcome of the study. The protocol concerning human subjects was approved by the ethics commission of the Charité University Medicine Berlin Campus Mitte, Germany .
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Alefacept
- Keywords
- Alefacept, Skin Diseases, Psoriasis, Skin Diseases, Papulosquamos, Therapeutic Uses, Dermatologic Agents
- Medical subject headings
- Skin Diseases, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
Also called LFA-3/IgG1 fusion protein
Alefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m.
| Study group | Role | What they receive |
|---|---|---|
| Alefacept | Experimental | Not described Receives: Drug: Alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of an extended courses of alefacept when administered to subjects with chronic plaque psoriasis. Safety parameters: Physical examinations; vital signs; infections; blood test: lymphocyte subset analysis (CD4+); and adverse events.
Measured: 12 + 4 weeks
Secondary outcomes (1)
Efficacy of an extended course of alefacept when administered to subjects with chronic plaque psoriasis: Time to requirement of additional systemic therapies, Psoriasis Area and Severity Index (PASI); Physician Global Assessment (PGA).
Measured: 12 + 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startFeb 2004
- Primary completionDec 2005
- Study completionDec 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 Charite University, Berlin, GermanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Wolfram Sterry, Prof. M.D., Study director, Department of Dermatology and Allergy, Charité-Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794807
- Sponsor's protocol ID
- A Study of an Extended Regimen
- Status last verified
- Nov 2008
- First submitted
- 19 Nov 2008
- Last updated
- 20 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Open-Label Followed by 4-Week Double-Blind Study to Determine the Safety and Efficacy of an Extended Course of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00794807
- Acronym / sponsor ID
- A Study of an Extended Regimen
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Alefacept, Skin Diseases, Psoriasis, Skin Diseases, Papulosquamos, Therapeutic Uses, Dermatologic Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Feb 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Nov 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.
Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larger studies, as well as the FDA-approved labeling, is confined to treatment courses of 12 weeks. The purpose of the present study is to offer an extended course of therapy with alefacept.
Detailed description
Twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (PASI: 7-36) were included in this study. They were treated with 15 mg alefacept i.m. weekly. Peripheral blood was taken prior to first alefacept application and then weekly until week five and thereafter every second week, until the end of treatment at week 13. At the same time points severity of disease and thereby possible reduction of symptoms was evaluated applying the PASI. Investigators analysing the samples were blinded to the outcome of the study. The protocol concerning human subjects was approved by the ethics commission of the Charité University Medicine Berlin Campus Mitte, Germany .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alefacept | Experimental | Drug: Alefacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must give written informed consent.
- Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1.
Key exclusion criteria (8 listed)
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
- Serious local infection (e.g., abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
- Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3.
- Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
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: LFA-3/IgG1 fusion proteinAlefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m. | Drug | Alefacept |
Primary outcome
Safety of an extended courses of alefacept when administered to subjects with chronic plaque psoriasis. Safety parameters: Physical examinations; vital signs; infections; blood test: lymphocyte subset analysis (CD4+); and adverse events.
Time frame: 12 + 4 weeks
1 secondary outcome
Efficacy of an extended course of alefacept when administered to subjects with chronic plaque psoriasis: Time to requirement of additional systemic therapies, Psoriasis Area and Severity Index (PASI); Physician Global Assessment (PGA).
Time frame: 12 + 4 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 20 Nov 2008.
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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.
Wolfram Sterry, Prof. M.D. study director
Department of Dermatology and Allergy, Charité-Universitaetsmedizin Berlin
1 site 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 in people with Chronic Plaque Psoriasis, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 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 20 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
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?
Safety of an extended courses of alefacept when administered to subjects with chronic plaque psoriasis. Safety parameters: Physical examinations; vital signs; infections; blood test: lymphocyte subset analysis (CD4+); and adverse events. (time frame: 12 + 4 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 20 Nov 2008.