Plaque PsoriasisPhase 2NCT00540618
A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
A Phase 2 study testing MEDI-507 in people with Plaque Psoriasis, run by MedImmune LLC at 43 sites in 2 countries.
Trial summary
To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- MEDI-507
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Sep 2001to Jul 2003
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plaque psoriasis involving at least 10% of body surface area
- 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
- 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 167 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)
Show all 14Show fewer
- Any documented immunodeficiency
- A history of prior administration of monoclonal antibodies or related proteins
- 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 15. Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States36 sites
Northeast Clinical Research Center
Allentown, Pennsylvania, 18104
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30005
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University Medical School
Chicago, Illinois, 60611-2923
University Dermatology Consultants, Inc.
Cincinnatti, Ohio, 45219
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210
Cherry Creek Dermatology
Denver, Colorado, 80246
Research Solutions, LLC
Evansville, Indiana, 47714
Associates in Research, Inc.
Fresno, California, 93710
Breco Research, Ltd.
Houston, Texas, 77024
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204
Harmony Clinical Research, Inc.
Johnson City, Tennessee, 37601
Clinicalm Partners-LLC
Johnston, Rhode Island, 02919
Bressinck-Parker-Dinehart-Sangster Dermatology, PA
Little Rock, Arkansas, 72205
Dermatology Consultants, PC
Nashville, Tennessee, 37205
Veteran's Administration Medical Center
Nashville, Tennessee, 37212-2637
University of Medicine & Dentistry of New Jersey Robert Wood Johnson Medical School and Clinical Research Center
New Brunswick, New Jersey, 08903-0019
The Savin Center, PC
New Haven, Connecticut, 06511
Sadick Research Group
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Paddington Testing Company
Philadelphia, Pennsylvania, 19103
Radiant Research
Philadelphia, Pennsylvania, 19115
MDS Pharma Services (US) Inc.
Phoenix, Arizona, 85040
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Probe Inc.
Riverside Park, New Jersey, 08075
Associates in Dermatology Research
Rutherford, New Jersey, 07070
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
nTouch Research Corporation
San Diego, California, 92103
ICSL-Clinical Studies
Sarasota, Florida, 34232
The South Bend Clinic
South Bend, Indiana, 46617
FutureCare Studies
Springfield, Massachusetts, 01107
Washington University School of Medicine
St Louis, Missouri, 63110
Comprehensive Research Institute
Tampa, Florida, 33607
Solano Clinical Research
Vallejo, California, 94589
Dermatology Specialists, Inc.
Vista, California, 92083
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Canada7 sites
The Dermatology Centre
Calgary, Alberta, T2S 3B3
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 1V8
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
International Dermatology Research
Montreal, Quebec, H3H 1V4
NewLab Clinical Research
St. John's, Newfoundland and Labrador, A1B 3E1
Probity Medical Research
Waterloo, Ontario, N2J 1B7
Probity Medical Research
Windsor, Ontario, N8X 3V6
About this study
Official title: A Phase II Randomized, Placebo-Controlled, Double-Blind Study of MEDI-507, A Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis.
To compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.
Read the detailed description
The primary objective of this study is to compare disease activity, as measured by PASI score, of three MEDI-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4 weeks) versus placebo administered weekly by SC injection.
- Conditions
- Plaque Psoriasis
- Being tested
- MEDI-507, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-507Drug
Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody)
PlaceboOther
MEDI-507Drug
Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks)
MEDI-507Drug
Administered 7 mg for 4 weeks by injection (Monoclonal Antibody)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI-507 Receives: Drug: MEDI-507 |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
| 3 | Active comparator | MEDI-507 Receives: Drug: MEDI-507 |
| 4 | Active comparator | MEDI-507 Receives: Drug: MEDI-507 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI)
Measured: Days 14, 28, 42, 56, 70, 91, 107, and 167
Secondary outcomes (1)
Observe adverse and serious adverse events
Measured: Day 107 and 167
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startSep 2001
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christine A Dingivan, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540618
- Sponsor's protocol ID
- MI-CP082
- Status last verified
- Nov 2007
- First submitted
- 4 Oct 2007
- Last updated
- 28 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Placebo-Controlled, Double-Blind Study of MEDI-507, A Humanized Monoclonal Antibody That Binds to the CD2 Receptor, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT00540618
- Acronym / sponsor ID
- MI-CP082
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Study completion
- Jul 2003 (actual)
- First posted
- 8 Oct 2007 (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 compare disease activity, as measured by PASI score, of three MEDI-507 dosing (injection)regimens vs. placebo.
Detailed description
The primary objective of this study is to compare disease activity, as measured by PASI score, of three MEDI-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4 weeks) versus placebo administered weekly by SC injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MEDI-507MEDI-507 |
| 2 | Placebo comparator | Other: Placebo |
| 3 | Active comparator | Drug: MEDI-507MEDI-507 |
| 4 | Active comparator | Drug: MEDI-507MEDI-507 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Plaque psoriasis involving at least 10% of body surface area
- 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
- 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 (14 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-507Compare in a placebo controlled manner, the disease activity of three dosing regimens of MEDI-507 (Monoclonal Antibody) | Drug | 1 |
| Placebo | Other | 2 |
| MEDI-507Monoclonal Antibody (5 mg for 12 weeks and 5 mg for 6 weeks) | Drug | 3 |
| MEDI-507Administered 7 mg for 4 weeks by injection (Monoclonal Antibody) | Drug | 4 |
Primary outcome
Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI)
Time frame: Days 14, 28, 42, 56, 70, 91, 107, and 167
1 secondary outcome
Observe adverse and serious adverse events
Time frame: Day 107 and 167
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 28 Nov 2007.
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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.
Christine A Dingivan, M.D. study director
MedImmune LLC
43 sites in 2 countries: 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 Plaque Psoriasis, run by MedImmune LLC at 43 sites in 2 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 6 inclusion and 14 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 28 Nov 2007. 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. 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. Some participants in this study may receive a placebo. 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?
Biological activity will be assessed primarily by the Psoriasis Activity and Severity Index (PASI) (time frame: Days 14, 28, 42, 56, 70, 91, 107, and 167). 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 28 Nov 2007.