PsoriasisPhase 2NCT00808223
Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis
A Phase 2 study testing alefacept in people with Psoriasis, run by Astellas Pharma Inc at 5 sites in 3 countries.
Trial summary
To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- 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
- 30 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2009to Feb 2012
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has moderate to severe chronic plaque psoriasis involving at least 10% or greater body surface area
- Subject is a candidate for systemic treatment or phototherapy
- Subject is in good health and alefacept is not contraindicated
- Subject must have absolute total CD4+ lymphocyte counts within the normal range at screening
- Female subjects of child bearing potential have a negative pregnancy test prior to first dose of alefacept and agree to practice effective contraception during the study
- Subject must have predosing laboratory findings without clinically significant abnormal values for hematocrit, hemoglobin, platelets, white blood count and differential, serum creatinine, bilirubin, ALT, AST and prothrombin.
Show all 9Show fewer
- Subject must have completed all standard childhood immunizations at least 12 weeks prior to the first dose
- Subject meets medication washout requirements and agrees to follow medication restrictions during the study
- Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits
Who cannot join
- Subject has a primary dermatological diagnosis of psoriasis other than plaque psoriasis
- Subject has a known hypersensitivity to alefacept or any excipient of the study medication
- Subject has had a serious local infection or systemic infection within 12 weeks prior to the first dose of study drug
- Subject has a fever (body temperature ≥ 38°C [or > 37°C for sites in Latvia]) or symptomatic viral or bacterial infection (including upper respiratory tract infection) within 1 week prior to the first dose of study drug
- Subject is known to be positive for HIV antibodies
- Subject has a history of chronic serious infection including hepatic disease or has positive result to serology test for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibody or, in Europe, tubercle bacillus (TB) at Screening
Show all 13Show fewer
- Subject has a history or evidence of tuberculosis based on serology or a positive PPD skin test at Screening
- Subject has had treatment with any immunosuppressant agent within 12 weeks, any antibody or immuno-globulin within 24 weeks, or any investigational drug or approved therapy for investigational use within 8 weeks prior to the first dose of study drug
- Subject has had more than six herpes simplex virus (HSV) breakouts per year or is currently having an outbreak or has had an outbreak within the last 24 weeks
- Subject has a history of malignancy (other than non-melanoma skin cancers)
- Subject has a chronic condition which is not well controlled
- Subject is pregnant or nursing
- Subject has a history of severe allergic or anaphylactic reactions
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Physicians Skin Care, PLLC
Louisville, Kentucky, 40217
Pediatric and Adolescent Dermatology
San Diego, California, 92123
Latvia2 sites
Skin and STD Clinical Centre
Riga, 1001
Department of Dermatology No.17, Children Clinical Hospital
Riga, 1004
Bulgaria1 site
First Municipal Hospital for Active Treatment - Sofia
Sofia, 1000
About this study
Official title: A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis [ISN 0485-CL-0004]
To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.
Read the detailed description
A planned interim analysis will be conducted to evaluate safety and pharmacokinetics following the Week 4 evaluation of approximately the first 12 subjects. A dose adjustment may be implemented based on these results. A preliminary review of the Week 4 pharmacokinetics of the first 6 subjects will occur to monitor exposure. If a dose adjustment is required, pharmacokinetics will be repeated for the first 12 subjects enrolled at the new dose (subjects 13-24).
- Conditions
- Psoriasis
- Being tested
- alefacept
- Keywords
- alefacept, adolescent, psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alefaceptBiological
Also called Amevive, ASP0485
IM injection
| Study group | Role | What they receive |
|---|---|---|
| 1. alefacept | Experimental | Not described Receives: Biological: alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections.
Measured: 6 months
Secondary outcomes (2)
Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets
Measured: 4 Weeks
Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionFeb 2012
- Study completionFeb 2012
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vice President Medical Affairs, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808223
- Sponsor's protocol ID
- 0485-CL-0004
- Other IDs
- 2008-005830-63, 2008
- Status last verified
- Dec 2013
- First submitted
- 11 Dec 2008
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis [ISN 0485-CL-0004]
- ClinicalTrials.gov ID
- NCT00808223
- Acronym / sponsor ID
- 0485-CL-0004
- Conditions
- Psoriasis
- Keywords
- alefacept, adolescent, psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 15 Dec 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.
To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.
Detailed description
A planned interim analysis will be conducted to evaluate safety and pharmacokinetics following the Week 4 evaluation of approximately the first 12 subjects. A dose adjustment may be implemented based on these results. A preliminary review of the Week 4 pharmacokinetics of the first 6 subjects will occur to monitor exposure. If a dose adjustment is required, pharmacokinetics will be repeated for the first 12 subjects enrolled at the new dose (subjects 13-24).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. alefacept | Experimental | Biological: alefacept |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Subject has moderate to severe chronic plaque psoriasis involving at least 10% or greater body surface area
- Subject is a candidate for systemic treatment or phototherapy
- Subject is in good health and alefacept is not contraindicated
- Subject must have absolute total CD4+ lymphocyte counts within the normal range at screening
- Female subjects of child bearing potential have a negative pregnancy test prior to first dose of alefacept and agree to practice effective contraception during the study
Key exclusion criteria (13 listed)
- Subject has a primary dermatological diagnosis of psoriasis other than plaque psoriasis
- Subject has a known hypersensitivity to alefacept or any excipient of the study medication
- Subject has had a serious local infection or systemic infection within 12 weeks prior to the first dose of study drug
- Subject has a fever (body temperature ≥ 38°C [or > 37°C for sites in Latvia]) or symptomatic viral or bacterial infection (including upper respiratory tract infection) within 1 week prior to the first dose of study drug
- Subject is known to be positive for HIV antibodies
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, ASP0485IM injection | Biological | 1. alefacept |
Primary outcome
Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections.
Time frame: 6 months
2 secondary outcomes
Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets
Time frame: 4 Weeks
Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled)
Time frame: 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 12 Dec 2013.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Vice President Medical Affairs study director
Astellas Pharma Global Development
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alefacept in people with Psoriasis, run by Astellas Pharma Inc at 5 sites in 3 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 9 inclusion and 13 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 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Latvia, Bulgaria. 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?
Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections. (time frame: 6 months). 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 12 Dec 2013.