PsoriasisPhase 3NCT00692172
Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
A Phase 3 study testing Alefacept in people with Psoriasis, run by Astellas Pharma Inc at 43 sites in 9 countries.
Trial summary
An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 175 participants
- Where
- 43 sitesin 9 countries
- Study dates
- Dec 2001to Nov 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
- Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728
Who cannot join
- Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
- Clinically significant abnormal hematology values or history of an immunosuppressive disorder
- Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- A significant change in the subject's medical history from their previous alefacept study
- Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
- 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)
Trial locations and contacts
43 sites in 9 countries.
43 sites in 9 countries
United States19 sites
Study site
Austin, Texas, 78759
Study site
Berlin, New Jersey, 08009
Study site
Chicago, Illinois, 60611
Study site
Clinton Township, Michigan, 48038
Study site
Fresno, California, 93710
Study site
Goodlettsville, Tennessee, 37072
Study site
Hot Springs, Arkansas, 71913
Study site
Jacksonville, Florida, 32204
Study site
Johnston, Rhode Island, 02919
Study site
Kansas City, Kansas, 66160
Study site
La Jolla, California, 92037
Study site
Lake Oswego, Oregon, 79035
Study site
Newnan, Georgia, 30263
Study site
Omaha, Nebraska, 68131
Study site
Pinellas Park, Florida, 33781
Study site
Portland, Oregon, 97210
Study site
San Antonio, Texas, 78229
Study site
St Louis, Missouri, 63110
Study site
Washington D.C., District of Columbia, 20010
Canada8 sites
Study site
Calgary, Alberta, T2S 3B3
Study site
London, Ontario, N6A 3H7
Study site
Moncton, New Brunswick, E1C 8X3
Study site
Sainte-Foy, Quebec, G1V 4X7
Study site
St. John's, Newfoundland and Labrador, A1B 4S8
Study site
Waterloo, Ontario, N2J 1C
Study site
Windsor, Ontario, N8W 5L7
Study site
Winnipeg, Manitoba, R3C ON2
France5 sites
Study site
Besançon, 25030
Study site
Brest, 29279
Study site
Nice, 06202
Study site
Paris, 75475
Study site
Tours, 37044
Belgium3 sites
Study site
Brussels, B-1070
Study site
Edegem, B-2650
Study site
Liège, 4000
Germany3 sites
Study site
Bochum, 44791
Study site
Dresden, 01307
Study site
Munich, 80337
About this study
Official title: An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712
An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.
- Conditions
- Psoriasis
- Being tested
- Alefacept
- Keywords
- psoriasis, alefacept, intramuscular
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
Also called Amevive, ASP0485
intramuscular injection (IM)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
Measured: Throughout treatment course
Secondary outcomes (1)
Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment
Measured: Every 2 weeks throughout treamtent course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startDec 2001
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692172
- Sponsor's protocol ID
- C-728
- Status last verified
- Sep 2014
- First submitted
- 4 Jun 2008
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E; Alefacept Clinical Study Group. The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14.
PubMed 20392521
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712
- ClinicalTrials.gov ID
- NCT00692172
- Acronym / sponsor ID
- C-728
- Conditions
- Psoriasis
- Keywords
- psoriasis, alefacept, intramuscular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Dec 2001
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 6 Jun 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.
An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | 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 have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
- Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728
Key exclusion criteria (6 listed)
- Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
- Clinically significant abnormal hematology values or history of an immunosuppressive disorder
- Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- A significant change in the subject's medical history from their previous alefacept study
- Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
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, ASP0485intramuscular injection (IM) | Drug | 1 |
Primary outcome
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
Time frame: Throughout treatment course
1 secondary outcome
Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment
Time frame: Every 2 weeks throughout treamtent course
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 18 Sep 2014.
- Background: PubMed 20392521Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E; Alefacept Clinical Study Group. The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14.
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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.
Central Contact study director
Astellas Pharma US, Inc.
43 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 Psoriasis, run by Astellas Pharma Inc at 43 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 2 inclusion and 6 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 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Canada, France, Belgium, Germany 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?
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring (time frame: Throughout treatment course). 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 NCT00692172, 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 Sep 2014.