PsoriasisPhase 2NCT00192517
Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
A Phase 2 study testing MEDI-522 in people with Psoriasis, run by MedImmune LLC at 20 sites in 2 countries.
Trial summary
The primary objective of this study is to compare the effects on disease activity, in the absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly by SC injection for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- MEDI-522
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Dec 2003to Sep 2004
- 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 (Appendix A)
- PASI score greater than 12
- 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
- Prior to randomization (must be within 21 days of the first administration of the study drug), all of the following: WBC less than or equal to 3,800/mm3; hematocrit above 32%, platelet count less than or equal to 140,000/mm3; AST, ALT, BUN, or creatinine<1.5 x ULN; and stool negative for occult blood
- Currently receiving no therapy for psoriasis except emollients
- 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
- Evidence of active hepatitis A, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
- 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)
- Evidence of significant active infection, such as fever less than or greater to 38.0°C (100.5°F), or chronic systemic infection
- Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies
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- Diagnosis of psoriatic arthritis or rheumatoid arthritis requiring active treatment
- History of hematuria due to chronic cystitis, recurrent kidney stones, or nephritis, history of CVA, poorly controlled hypertension, angina, stable abdominal aneurysm, recent superficial phlebitis, or recent myocardial infarction (within past 1 year without definitive corrective surgery such as coronary bypass graft or angioplasty)
- Receipt of systemic therapy for psoriasis or immunosuppressive medication in the past 4 weeks, including systemic retinoids, systemic steroids (oral, IM, or IV), cyclosporine A,methotrexate, azathioprine, anti-TNF agents, anti-T-cell agents, phototherapy (PUVA, UVB,tanning bed use), coal tar treatment (Goeckerman or modified Goeckerman regimen), tacrolimus, or mycophenolate
- Use of topical therapy for psoriasis in the past 2 weeks, such as steroid containing creams, Vitamin D analog creams and coal tar shampoos
- Receipt of any investigational drug therapy within 4 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
- History of allergic disease or reactions likely to be exacerbated by any component of MEDI-522
- Nursing mother
- Evidence of acute illness
- Clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the patient in the study
- History of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months
- Known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin
- Insulin-dependent diabetes mellitus that is recent-onset or unstable
- Elective surgery planned during the study period through Study Day 167
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States18 sites
NorthEast Clinical Research Centers, Inc
Allentown, Pennsylvania, 18103
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30005
University of Cincinnati
Cincinnati, Ohio, 45219
Midwest Cutaneous Research, Corp.
Clinton Township, Michigan, 48038
Associates In Research, Inc.
Fresno, California, 93710
North Florida Dermatology Associates, P.A.
Jacksonville, Florida, 32204
Harmony Clinical Research
Johnson City, Tennessee, 37601
Clincial Partners, LLC
Johnston, Rhode Island, 02919
Bressinck, Gibson, Parker, Dinehart, Sanster Dermatology, PA
Little Rock, Arkansas, 72205
Tenn. Clinical Research Center, INC
Nashville, Tennessee, 37215
The Savin Center, P.C.
New Haven, Connecticut, 06511-4808
Karen Harkaway, M.D., LLC
Riverside Park, New Jersey, 08075
Derm. Clinical Research Center of San Antonio
San Antonio, Texas, 78229
South Bend Clinic
South Bend, Indiana, 46617
FutureCare Studies, INC
Springfield, Massachusetts, 01107
Central Dermatology
St Louis, Missouri, 63117
Solano Dermatology Associates
Vallejo, California, 94589
Dermatology Specialists
Vista, California, 92083
Canada2 sites
North Bay Dermatology Center
North Bay, Ontario, P1B 2T6
Probity Medical Research, Inc.
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of MEDI-522, a Humanized Monoclonal Antibody to Integrin Alpha V Beta 3, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
The primary objective of this study is to compare the effects on disease activity, in the absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly by SC injection for 12 weeks.
- Conditions
- Psoriasis
- Being tested
- MEDI-522, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-522Drug
4 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
PlaceboOther
4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI-522 Receives: Drug: MEDI-522 |
| 2 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving at least a 50% or 75% improvement of PASI
Measured: PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.
Secondary outcomes (1)
Incidence of adverse events and serious adverse events
Measured: through Study Day 167
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 startDec 2003
- Primary completionAug 2004
- Study completionSep 2004
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barbara White, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192517
- Sponsor's protocol ID
- MI-CP102
- Status last verified
- Apr 2009
- First submitted
- 13 Sep 2005
- Last updated
- 3 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. 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-522, a Humanized Monoclonal Antibody to Integrin Alpha V Beta 3, Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00192517
- Acronym / sponsor ID
- MI-CP102
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Sep 2004 (actual)
- 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 the effects on disease activity, in the absence of systemic psoriasis therapy, of 4 mg/kg MEDI-522 versus placebo administered weekly by SC injection for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MEDI-522MEDI-522 |
| 2 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Plaque psoriasis involving at least 10% of body surface area (Appendix A)
- PASI score greater than 12
- 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
- Prior to randomization (must be within 21 days of the first administration of the study drug), all of the following: WBC less than or equal to 3,800/mm3; hematocrit above 32%, platelet count less than or equal to 140,000/mm3; AST, ALT, BUN, or creatinine<1.5 x ULN; and stool negative for occult blood
Key exclusion criteria (20 listed)
- Pustular, guttate, or erythrodermic psoriasis as the predominant disease type
- Evidence of active hepatitis A, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
- 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)
- Evidence of significant active infection, such as fever less than or greater to 38.0°C (100.5°F), or chronic systemic infection
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-5224 mg/kg (for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0) | Drug | 1 |
| Placebo4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0) | Other | 2 |
Primary outcome
Percentage of subjects achieving at least a 50% or 75% improvement of PASI
Time frame: PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.
1 secondary outcome
Incidence of adverse events and serious adverse events
Time frame: through Study Day 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 3 Apr 2009.
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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.
Barbara White, M.D. study director
MedImmune LLC
20 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-522 in people with Psoriasis, run by MedImmune LLC at 20 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 8 inclusion and 20 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 3 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Percentage of subjects achieving at least a 50% or 75% improvement of PASI (time frame: PASI score at Study Days 28, 56, 77, 91, 107, 137, 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 3 Apr 2009.