Moderate to Severe PsoriasisNCT00678470
Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis
A study testing Intralesional Alefacept in people with Moderate to Severe Psoriasis, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Psoriasis
- What is being tested?
- Intralesional Alefacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are nonimmunocompromised males or females 18 years of age or older
- Subjects have moderate to severe plaque-type psoriasis.
- Subjects have a Body Surface Area (BSA) involvement of greater than 5%.
- Subjects have a Psoriasis Area and Severity Index (PASI) greater than 10.
- Subjects have three psoriatic lesions with psoriasis severity score greater than or equal to 6 and an induration score greater than or equal to 2.
- Subjects' target lesions are greater than 2 cm2 preferably on similar anatomical regions.
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- Subjects are eligible for systemic therapy, particularly alefacept, in the opinion of the investigator.
- Before any study-specific procedure, subject must sign/date the appropriate written informed consent, HIPAA authorization, and a photography consent form.
- Negative urine pregnancy test within 7 days before the first dose of alefacept in all women (except those surgically sterile or at least 1 years postmenopausal)
- Subjects must be in general good health with no other skin disease, state of physical condition which would impair evaluation of psoriasis or which would increase their health risk by study participation.
- Subject agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject.
- Subject meets concomitant medication washout requirements.
Who cannot join
- Subjects with erythrodermic, pustular, or guttate psoriasis.
- Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- Subject has a known sensitivity to any component of the study medications.
- Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits.
- Subjects whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
- History of immune compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency.
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- Subject has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk.
- Subject has a history of or ongoing drug or alcohol abuse.
- 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.
- Subject plans to receive any live vaccines during the study.
- Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to Week 0.
- Subjects that cannot commit to all the assessments required by the protocol.
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for study participation.
- Subjects that cannot or do not wish to comply with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118
About this study
Official title: A Single Arm, Open Label Study to Explore if Response to Intralesional Alefacept Injections Prior to the Standard Course of Intramuscular Treatment Can Predict Clinical Outcomes in Patients With Moderate to Severe Chronic Plaque Psoriasis
This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3 and an induration score greater than 1 will be identified on each patient. Each lesion will receive only one intralesional alefacept injection during the first three weeks of the study (1 lesion per week). Following a 2 week observation period, subjects will undergo a standard 12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept treatments. An 8 week follow-up period will begin after the last dose of alefacept is administered where safety and efficacy measures will continue to be monitored as outlined in the study procedures. The hypothesis is that the response to intralesional alefacept injections, whether it is positive or no benefit, will predict the clinical response to intramuscular alefacept administration.
Read the detailed description
See Brief Summary
- Conditions
- Moderate to Severe Psoriasis
- Being tested
- Intralesional Alefacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional AlefaceptDrug
Also called Amevive
Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Investigational intervention without random assignment Receives: Drug: Intralesional Alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Either or Both Intralesional Response and Systemic Response
Target plaque assessment completed using local Physician's Global Assessment score (PGA). Systemic response measured by comparing Psoriasis Area and Severity Index score at week 22 compared to baseline. Correlation measured using Fisher's non parametric test of association.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe PsoriasisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina Bhutani, University of California, San Francisco
- Investigators
- John Koo, MD, Principal investigator, UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678470
- Sponsor's protocol ID
- KOO-AMEVIVE-2008
- Other IDs
- CHR-H5939-31199-01
- Status last verified
- Apr 2019
- First submitted
- 13 May 2008
- Last updated
- 18 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bhutani T, Kamangar F, Zitelli K, Chiang C, Gattu S, Nguyen T, Becker E, Koo J. Intralesional injections of alefacept may predict systemic response to intramuscular alefacept: results from a pilot study. J Dermatolog Treat. 2013 Oct;24(5):348-50. doi: 10.3109/09546634.2012.672712. Epub 2012 Jun 5.
PubMed 22506829
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label Study to Explore if Response to Intralesional Alefacept Injections Prior to the Standard Course of Intramuscular Treatment Can Predict Clinical Outcomes in Patients With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00678470
- Acronym / sponsor ID
- KOO-AMEVIVE-2008
- Conditions
- Moderate to Severe Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 15 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3 and an induration score greater than 1 will be identified on each patient. Each lesion will receive only one intralesional alefacept injection during the first three weeks of the study (1 lesion per week). Following a 2 week observation period, subjects will undergo a standard 12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept treatments. An 8 week follow-up period will begin after the last dose of alefacept is administered where safety and efficacy measures will continue to be monitored as outlined in the study procedures. The hypothesis is that the response to intralesional alefacept injections, whether it is positive or no benefit, will predict the clinical response to intramuscular alefacept administration.
Detailed description
See Brief Summary
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Intralesional AlefaceptInvestigational intervention without random assignment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects are nonimmunocompromised males or females 18 years of age or older
- Subjects have moderate to severe plaque-type psoriasis.
- Subjects have a Body Surface Area (BSA) involvement of greater than 5%.
- Subjects have a Psoriasis Area and Severity Index (PASI) greater than 10.
- Subjects have three psoriatic lesions with psoriasis severity score greater than or equal to 6 and an induration score greater than or equal to 2.
Key exclusion criteria (15 listed)
- Subjects with erythrodermic, pustular, or guttate psoriasis.
- Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- Subject has a known sensitivity to any component of the study medications.
- Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits.
- Subjects whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
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 |
|---|---|---|
| Intralesional AlefaceptAlso: AmevivePatients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks. | Drug | Single Arm |
Primary outcome
Number of Participants With Either or Both Intralesional Response and Systemic Response
Time frame: 22 weeks
Target plaque assessment completed using local Physician's Global Assessment score (PGA). Systemic response measured by comparing Psoriasis Area and Severity Index score at week 22 compared to baseline. Correlation measured using Fisher's non parametric test of association.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22506829Bhutani T, Kamangar F, Zitelli K, Chiang C, Gattu S, Nguyen T, Becker E, Koo J. Intralesional injections of alefacept may predict systemic response to intramuscular alefacept: results from a pilot study. J Dermatolog Treat. 2013 Oct;24(5):348-50. doi: 10.3109/09546634.2012.672712. Epub 2012 Jun 5.
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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.
John Koo, MD principal investigator
UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralesional Alefacept in people with Moderate to Severe Psoriasis, run by University of California, San Francisco 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 12 inclusion and 15 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 18 Apr 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Either or Both Intralesional Response and Systemic Response (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678470, which also lists 1 linked publication.
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 18 Apr 2019.