PsoriasisPhase 2NCT00150982
Alefacept Mechanism of Action in Psoriasis
A Phase 2 study testing Mechanism of action of alefacept in people with Psoriasis, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
To determine the mechanism of action of alefacept in patients with psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Mechanism of action of alefacept
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Feb 2005
- Phase
- Phase 2
- 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
- Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies).
Who cannot join
- CD4 < 400/ml
- WBC less than lower level of normal for the reporting laboratory
- < 5% Body Surface Area involved with psoriasis
- Serious infection e.g., latent or active tuberculosis
- History of AIDS or Hepatitis B,C, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma
- Systemic anti-psoriasis medications and phototherapy within 28 days of the first dose of Alefacept
Show all 11Show fewer
- Topical anti-psoriasis medications within 14 days of the first dose of Alefacept, except for moisturizers, tar shampoos (exception, Elidel is permitted to be applied on the face, groin and axillae areas. These areas are not biopsied.)
- Inability to understand consent form or comply with study requirements
- Pregnancy or lactation
- Concurrent medical illness that would make participation in this clinical trial ill-advised
- Any contraindications to using alefacept
Trial locations and contacts
1 site in 1 country.
United States1 site
UMDNJ Clinical Research Center
New Brunswick, New Jersey, 08903
About this study
Official title: In Vivo Induction of T Cell Apoptosis by Alefacept (LFA-3/IgG1 Fusion Protein, Amevive) in Patients With Psoriasis: An Investigator-Initiated, Open-Label, Mechanism of Action Study
To determine the mechanism of action of alefacept in patients with psoriasis.
Read the detailed description
The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.
- Conditions
- Psoriasis
- Being tested
- Mechanism of action of alefacept
- Keywords
- psoriasis, alefacept
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanism of action of alefaceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
Secondary outcomes (1)
To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Alice Gottlieb, MD, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150982
- Sponsor's protocol ID
- 4588
- Status last verified
- Aug 2008
- First submitted
- 6 Sep 2005
- Last updated
- 7 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Induction of T Cell Apoptosis by Alefacept (LFA-3/IgG1 Fusion Protein, Amevive) in Patients With Psoriasis: An Investigator-Initiated, Open-Label, Mechanism of Action Study
- ClinicalTrials.gov ID
- NCT00150982
- Acronym / sponsor ID
- 4588
- Conditions
- Psoriasis
- Keywords
- psoriasis, alefacept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Sep 2003
- Study completion
- Feb 2005
- First posted
- 8 Sep 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.
To determine the mechanism of action of alefacept in patients with psoriasis.
Detailed description
The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies).
Key exclusion criteria (11 listed)
- CD4 < 400/ml
- WBC less than lower level of normal for the reporting laboratory
- < 5% Body Surface Area involved with psoriasis
- Serious infection e.g., latent or active tuberculosis
- History of AIDS or Hepatitis B,C, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma
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 |
|---|---|---|
| Mechanism of action of alefacept | Drug | – |
Primary outcome
To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
1 secondary outcome
To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts.
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 7 Aug 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.
Alice Gottlieb, MD, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mechanism of action of alefacept in people with Psoriasis, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
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 1 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 7 Aug 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo. 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 7 Aug 2008.