PsoriasisPhase 2NCT00192452
Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque Psoriasis
A Phase 2 study testing MEDI-507 in people with Psoriasis, run by MedImmune LLC at 3 sites in United States.
Trial summary
The primary objective of this study is to compare disease activity, as measured by PASI score, of two MEDI-507 dose levels (0.012 and 0.04 mg/kg) versus placebo administered by intravenous infusion every 2 weeks for a total of 8 infusions. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- MEDI-507
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2001to Dec 2001
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Plaque psoriasis involving at least 10% of body surface area (Appendix B)
- Age 18 through 65 years at the time of the first dose of study drug
- Both males and females are eligible. However, sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug and must agree to continue using such precautions for 60 days after the final dose of study drug
- Currently receiving no therapy for psoriasis except emollients (certain other over-the-counter products may be allowed with prior approval of the sponsor)
- Written informed consent obtained from the patient
- Ability to complete follow-up period of 188 days as required by the protocol
Who cannot join
- Pustular, guttate, or erythrodermic psoriasis as the predominant disease type
- PASI score <8
- At screening (must be within 21 days before study entry) any of the following: lymphocyte count under 1,200 cells/mm3, WBC under 4,000 cells/mm3, hematocrit below 32%, platelets below 110,000 cells/mm3, creatinine, AST, ALT over 1.5 times upper limit of normal
- At screening (must be within 21 days before study entry) any clinical evidence of HIV, hepatitis B, hepatitis C or active hepatitis A infection
- Pregnancy (must have a negative serum pregnancy test within 21 days prior to the first dose of study drug, and urine pregnancy test must be negative on Study Day 0 before study entry)
- History of cancer (except excision of basal cell carcinoma)
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- Any documented immunodeficiency
- A history of prior administration of monoclonal antibodies or related proteins, with the exception of MEDI-507 (Note: prior recipients of MEDI-507 will require review and approval by the sponsor prior to entry)
- Receipt of systemic retinoids, corticosteroids, cyclosporin A, methotrexate, phototherapy or coal tar treatment in the past 4 weeks
- Use of topical therapy (except emollients) for psoriasis in the past 2 weeks (certain other over-the-counter products may be allowed with prior approval of the sponsor)
- Receipt of any investigational drug therapy within 6 weeks before the first dose of study drug in this protocol (use of licensed agents for indications not listed in the package insert is permitted)
- Current or planned participation in a research protocol in which an investigational agent or therapy may be administered
- Nursing mother
- Acute illness including infections
- Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study
- A known drug allergy or medical contraindication to ibuprofen
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MDS Pharma Services (US) Inc.
Phoenix, Arizona, 85044
Northwest Kinetics
Tacoma, Washington, 98403
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of MEDI-507, a Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Intravenous Infusion to Adults With Plaque Psoriasis
- The primary objective of this study is to compare disease activity, as measured by PASI score, of two MEDI-507 dose levels (0.012 and 0.04 mg/kg) versus placebo administered by intravenous infusion every 2 weeks for a total of 8 infusions.
- Conditions
- Psoriasis
- Being tested
- MEDI-507
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-507Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyses of categorical data will be performed and analysis of continuous data will be performed using a one-way analysis of variance (ANOVA) with traetment group as a factor.
Secondary outcomes (1)
Percentage of subjects with at least 75% improvement and those with at least 50% improvement will be compared.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2001
- Study completionDec 2001
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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stanley Pillemer, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192452
- Sponsor's protocol ID
- MI-CP074
- Status last verified
- Oct 2006
- First submitted
- 13 Sep 2005
- Last updated
- 25 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled Study of MEDI-507, a Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Intravenous Infusion to Adults With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00192452
- Acronym / sponsor ID
- MI-CP074
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Study completion
- Dec 2001
- First posted
- 19 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.
- The primary objective of this study is to compare disease activity, as measured by PASI score, of two MEDI-507 dose levels (0.012 and 0.04 mg/kg) versus placebo administered by intravenous infusion every 2 weeks for a total of 8 infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Plaque psoriasis involving at least 10% of body surface area (Appendix B)
- Age 18 through 65 years at the time of the first dose of study drug
- Both males and females are eligible. However, sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug and must agree to continue using such precautions for 60 days after the final dose of study drug
- Currently receiving no therapy for psoriasis except emollients (certain other over-the-counter products may be allowed with prior approval of the sponsor)
- Written informed consent obtained from the patient
Key exclusion criteria (16 listed)
- Pustular, guttate, or erythrodermic psoriasis as the predominant disease type
- PASI score <8
- At screening (must be within 21 days before study entry) any of the following: lymphocyte count under 1,200 cells/mm3, WBC under 4,000 cells/mm3, hematocrit below 32%, platelets below 110,000 cells/mm3, creatinine, AST, ALT over 1.5 times upper limit of normal
- At screening (must be within 21 days before study entry) any clinical evidence of HIV, hepatitis B, hepatitis C or active hepatitis A infection
- Pregnancy (must have a negative serum pregnancy test within 21 days prior to the first dose of study drug, and urine pregnancy test must be negative on Study Day 0 before study entry)
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 |
|---|---|---|
| MEDI-507 | Drug | – |
Primary outcome
Analyses of categorical data will be performed and analysis of continuous data will be performed using a one-way analysis of variance (ANOVA) with traetment group as a factor.
1 secondary outcome
Percentage of subjects with at least 75% improvement and those with at least 50% improvement will be compared.
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 25 Oct 2006.
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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.
Stanley Pillemer, MD study director
MedImmune LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI-507 in people with Psoriasis, run by MedImmune LLC at 3 sites 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 6 inclusion and 16 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 25 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Analyses of categorical data will be performed and analysis of continuous data will be performed using a one-way analysis of variance (ANOVA) with traetment group as a factor.. 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 25 Oct 2006.