Chronic Plaque PsoriasisPhase 1CP145NCT00472758
A Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose for MEDI-545
A Phase 1 study testing MEDI 545 in people with Chronic Plaque Psoriasis, run by MedImmune LLC at 3 sites in Canada.
Trial summary
-To evaluate the safety and tolerability of a multiple doses of this drug in adult patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- MEDI 545
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2007to Mar 2008
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults, age 18 through 70 years of age at time of screening;
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
- Documented clinical history of chronic plaque psoriasis;
- ≥ 3% body surface area (BSA) involvement in affected skin other than the face and scalp;
- Have at least two target plaques that are suitable for serial photographic assessments, one of which is of a size and location to allow serial biopsies;
- No significant changes in regular psoriasis treatment from at least 28 days from screening through the time of study drug administration;
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- Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner or sterile sexual partner) for 21 days prior to study drug administration, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom with spermicide) and must agree to continue using such precautions through Study Day 126;
- Willing to forego other forms of experimental treatment and study procedures during the study; and
- Ability to complete the study period, including follow-up period through Study Day 126.
Who cannot join
- Receipt of MEDI-545 in any previous clinical study;
- History of allergy or reaction to any component of the MEDI-545 formulation;
- Pustular, guttate, or erythrodermic psoriasis as the predominant disease type;
- Current use of potent topical corticosteroids, tacrolimus, or calcipotriol from 28 days prior to screening through study drug administration;
- Current use of phototherapy including tanning beds, Goeckerman or modified Goeckerman regimen, systemic corticosteroids, cyclosporin A, azathioprine, mycophenolate mofetil, methotrexate, or any other systemic treatment for psoriasis within 28 days prior to screening up through study drug administration;
- Current use of biologic agents such as alefacept or tumor necrosis factor-α inhibitors within 90 days prior to screening up through study drug administration;
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- Any disease or illness, other than chronic plaque psoriasis, that may require the use of systemic corticosteroids during the study period;
- Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (≥ 100.5°F) from screening through study drug administration;
- Receipt of any investigational drug therapy or attenuated live vaccine therapy (other than vaccination against influenza) within 30 days or 5 half-life periods (whichever is longer) prior to study drug administration through the end of study;
- Pregnancy (sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
- Breastfeeding or lactating women;
- Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus (HIV)-1 or -2, or active infection with hepatitis A, as determined by results of testing at screening;
- A history of severe infection with cytomegalovirus or viruses of the herpes family including Epstein-Barr virus requiring hospitalization, disseminated herpes, herpes encephalitis, or ophthalmic herpes;
- Herpes zoster within 3 months prior to screening;
- Current suppressive antiviral therapy for herpes or other viral infections;
- A history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 1 year prior to randomization;
- Elective surgery planned during the study period through end of study;
- Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram (ECG) or chest radiograph at screening;
- A history of coagulation disorders;
- History of primary immunodeficiency;
- History of stroke, or any cerebrovascular disease requiring current medication/treatment;
- In the opinion of the investigator, clinically significant active cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; or arrhythmia requiring active therapy;
- Ongoing, clinically significant (in the opinion of the investigator) chronic infectious disease;
- History of active tuberculosis or positive tuberculosis (TB) test (defined as a reaction ≥ 10 mm in diameter) without a completed course of appropriate medical treatment;
- At the time of screening, any of the following: clinically significant abnormalities of hemoglobin, total white blood cell count, or platelet count; aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times the upper limits of normal (ULN), serum creatinine, and prothrombin time (PT) or partial thromboplastin time (PTT) > ULN;
- Any other abnormal laboratory values in the screening panel that, in the opinion of the investigator, are clinically significant. Abnormal results on screening laboratory tests may be repeated once at the discretion of the site investigator(s) or qualified designee, prior to Study Day 0, to determine eligibility; or
- Evidence of any systemic disease or skin disease (other than chronic plaque psoriasis), any finding upon physical examination or history of any disease that, in the opinion of the investigator, designated health care provider, or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Innovaderm Research, Laval, Inc.
Laval-Quebec, H7S 2C5
Innovaderm Research, Inc.
Montreal, H2K 4L5
Probity Medical Research
Waterloo- Ontario, N2J 1C4
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose, Intravenously Administered MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Chronic Plaque Psoriasis
-To evaluate the safety and tolerability of a multiple doses of this drug in adult patients.
Read the detailed description
-The primary objective of the study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-545 in adult patients with chronic plaque psoriasis.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- MEDI 545, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI 545Biological
IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
PlaceboOther
IV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI 545 Receives: Biological: MEDI 545 |
| 2 | Placebo comparator | Placebo IV Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of MEDI-545 will be assessed through the collection of AEs and SAEs from study drug administration through Study Day 126.
Measured: Through day 26
Secondary outcomes (1)
Secondary endpoints are the PK and IM of single-dose IV MEDI-545.
Measured: determination not stated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara White, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472758
- Sponsor's protocol ID
- MI-CP145
- Acronym
- CP145
- Status last verified
- Nov 2011
- First submitted
- 11 May 2007
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose, Intravenously Administered MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00472758
- Acronym / sponsor ID
- CP145 / MI-CP145
- Conditions
- Chronic Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 May 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 evaluate the safety and tolerability of a multiple doses of this drug in adult patients.
Detailed description
-The primary objective of the study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-545 in adult patients with chronic plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: MEDI 545MEDI 545 |
| 2 | Placebo comparator | Other: PlaceboPlacebo IV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female adults, age 18 through 70 years of age at time of screening;
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
- Documented clinical history of chronic plaque psoriasis;
- ≥ 3% body surface area (BSA) involvement in affected skin other than the face and scalp;
- Have at least two target plaques that are suitable for serial photographic assessments, one of which is of a size and location to allow serial biopsies;
Key exclusion criteria (27 listed)
- Receipt of MEDI-545 in any previous clinical study;
- History of allergy or reaction to any component of the MEDI-545 formulation;
- Pustular, guttate, or erythrodermic psoriasis as the predominant disease type;
- Current use of potent topical corticosteroids, tacrolimus, or calcipotriol from 28 days prior to screening through study drug administration;
- Current use of phototherapy including tanning beds, Goeckerman or modified Goeckerman regimen, systemic corticosteroids, cyclosporin A, azathioprine, mycophenolate mofetil, methotrexate, or any other systemic treatment for psoriasis within 28 days prior to screening up through study drug administration;
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 545IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg | Biological | 1 |
| PlaceboIV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg | Other | 2 |
Primary outcome
Safety and tolerability of MEDI-545 will be assessed through the collection of AEs and SAEs from study drug administration through Study Day 126.
Time frame: Through day 26
1 secondary outcome
Secondary endpoints are the PK and IM of single-dose IV MEDI-545.
Time frame: determination not stated
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 17 Nov 2011.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI 545 in people with Chronic Plaque Psoriasis, run by MedImmune LLC at 3 sites in Canada.
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 27 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 17 Nov 2011. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability of MEDI-545 will be assessed through the collection of AEs and SAEs from study drug administration through Study Day 126. (time frame: Through day 26). 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 17 Nov 2011.