LupusPhase 1NCT00299819
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing MEDI-545 and MEDI 545 in people with Lupus, run by MedImmune LLC at 21 sites in 2 countries.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus
- What is being tested?
- MEDI-545 and MEDI 545
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Mar 2006to Oct 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria:
- Adult males and females ≥ 18 years at the time of the first dose of study drug.
- Written informed consent obtained from the patient/patient's legal guardian
- Diagnosis of SLE: Patients must have previously met ≥ 4 of the 11 revised ACR criteria
- Current background treatments may include the following medications prior to randomization: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and antimalarials, such as hydroxychloroquine ≤ 600 mg/day, and prednisone ≤ 20 mg daily (or an equivalent dose of another oral corticosteroid) for at least 28 days
- Sexually active females, unless surgically sterile or at least two years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, 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 28 days before the first dose of study drug, and must agree to continue using such precautions through the study period of 84 days. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through Study Day 84.
- Ability to complete follow-up period of 84 days as required by the protocol.
Who cannot join
- Weight ≥ 120 kg
- Use of cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil or cyclosporine within 28 days before study entry
- Use of doses of corticosteroids higher than the equivalent of prednisone 20 mg/day (or an equivalent dose of another corticosteroid) within 28 days before study entry
- In the opinion of the investigator, a likelihood of requiring initiation of immunosuppressant therapy (e.g., prednisone >20 mg daily (or an equivalent dose of another oral corticosteroid), azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, or dapsone) within the 28 days after study entry. Antimalarial dosing must be held constant during the study, but analgesics and NSAIDs may be varied.
- Current treatment with coumadin
- Treatment with immunoglobulin or blood products within 28 days before entry into the study
Show all 34Show fewer
- Treatment with any investigational drug therapy within 28 days before entry into the study; in the case of cell-depleting therapies, such as B or T cell depletion, cell counts that remain below acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted)
- History of primary immunodeficiency
- History of allergic reactions likely to be exacerbated by any component of the study drug
- Previous medical history, or evidence, of an intercurrent illness, other than SLE, that may compromise the safety of the patient in the study
- Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extra systoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
- Evidence of significant active infection, or vaccination with live attenuated viruses, currently or in the 2 weeks before randomization
- Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening
- A history of severe infection with viruses of the herpes family including Epstein-Barr virus requiring hospitalization, disseminated herpes, herpes encephalitis, ophthalmic herpes, or cytomegalovirus
- Herpes zoster ≤ 3 months prior to screening
- Current suppressive antiviral therapy for herpes or other viral infections
- Ongoing, chronic infectious disease such as chronic renal infection or chronic chest infection with bronchiectasis or sinusitis
- Pregnancy (females, unless surgically sterile or at least two years post-menopausal must have a negative serum pregnancy test within 14 days before receiving the study drug and a negative urine pregnancy test on Study Day 0 before receiving the study drug)
- Nursing mother
- History of alcohol or drug abuse within the past 2 years
- Presence of end-stage renal disease, or rapidly progressive glomerulonephritis
- Active central nervous system lupus
- History of stroke, or any cerebrovascular disease requiring medication/treatment.
- History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >1 year prior to enrollment
- At screening (must be within14 days before entry into the study) any of the following:
- AST > 1.5x upper limit of normal range (ULN)
- ALT > 1.5x ULN
- creatinine > 1.5x ULN for patient's age, sex and weight
- serum K above or below the normal range
- hemoglobin < 8 g/dL
- white blood cell count < 1,800/mm3 (Superscript)
- neutrophils < 1,500/mm3 (Superscript)
- platelet count < 50,000/mm3 (Superscript)
- other abnormal laboratory values in the screening panel that in the opinion of the principal investigator are judged to potentially confound analysis of study results
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
Pinnacle Research Group
Anniston, Alabama, 35207
Johns Hopkins University, School of Medicine
Baltimore, Maryland, 21205
Clinical Research of West Florida
Clearwater, Florida, 33765
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Center for Rhematology, Immunology, and Arthritis
Fort Lauderdale, Florida, 03334
Wallace Rheumatic Study Center
Los Angeles, California, 90048
Center for Innovative Therapy, UCSD School of Medicine
Milwaukee, Wisconsin, 53226
Froedtert Hospital, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hospital for Special Surgery
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Ocala Rheumatology Research Center
Ocala, Florida, 34474
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Oregon Medical Research Center
Portland, Oregon, 97223
University of Washington Div. of Rhematology
Seattle, Washington, 98195
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, 71130
Tampa Florida Medical Research Group
Tampa, Florida, 33614
Florida Medical Clinic, Clinical Research Division
Zephyrhills, Florida, 33542
Canada2 sites
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Toronto Western Hospital
Toronto, Ontario, MST 258
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients who have SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.
The secondary objective of this study is to describe the pharmacokinetics and potential immunogenicity of MEDI-545.
- Conditions
- Lupus
- Being tested
- MEDI-545, MEDI 545
- Keywords
- Lupus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-545Biological
0.3 mg/kg IV (n=6) at Study Day 0
MEDI 545Biological
0.3 mg/kg IV (n=6) at Study Day 0
MEDI-545Biological
0.3 mg/kg IV (n=6) at Study Day 0
MEDI-545Biological
0.3 mg/kg IV (n=6) at Study Day 0
MEDI-545Biological
0.3 mg/kg IV (n=6) at Study Day 0
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI-545 Receives: Biological: MEDI 545 |
| 2 | Active comparator | MEDI-545 Receives: Biological: MEDI-545 |
| 3 | Active comparator | MEDI-545 Receives: Biological: MEDI-545 |
| 4 | Active comparator | MEDI-545 Receives: Biological: MEDI-545 |
| 5 | Active comparator | MEDI-545 Receives: Biological: MEDI-545 |
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 primarily by summarizing adverse events.
Measured: Day 84
Secondary outcomes (1)
Evaluation of MEDI-545 pharmacokinetics and possible immunogenicity
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startMar 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LupusStudies 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
- 45 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
- NCT00299819
- Sponsor's protocol ID
- MI-CP126
- Status last verified
- Dec 2007
- First submitted
- 6 Mar 2006
- Last updated
- 18 Dec 2007
- Results posted
- No
Publications
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PubMed 33687069Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, Robbie G, Levin R, Berney SM, Chindalore V, Olsen N, Richman L, Le C, Jallal B, White B; Lupus Interferon Skin Activity (LISA) Study Investigators. Safety profile and clinical activity of sifalimumab, a fully human anti-interferon alpha monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study. Ann Rheum Dis. 2011 Nov;70(11):1905-13. doi: 10.1136/ard.2010.144485. Epub 2011 Jul 27.
PubMed 21798883Yao Y, Richman L, Higgs BW, Morehouse CA, de los Reyes M, Brohawn P, Zhang J, White B, Coyle AJ, Kiener PA, Jallal B. Neutralization of interferon-alpha/beta-inducible genes and downstream effect in a phase I trial of an anti-interferon-alpha monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum. 2009 Jun;60(6):1785-96. doi: 10.1002/art.24557.
PubMed 19479852
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT00299819
- Acronym / sponsor ID
- MI-CP126
- Conditions
- Lupus
- Keywords
- Lupus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 7 Mar 2006 (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 evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients who have SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.
The secondary objective of this study is to describe the pharmacokinetics and potential immunogenicity of MEDI-545.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: MEDI 545MEDI-545 |
| 2 | Active comparator | Biological: MEDI-545MEDI-545 |
| 3 | Active comparator | Biological: MEDI-545MEDI-545 |
| 4 | Active comparator | Biological: MEDI-545MEDI-545 |
| 5 | Active comparator | Biological: MEDI-545MEDI-545 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must meet all of the following criteria:
- Adult males and females ≥ 18 years at the time of the first dose of study drug.
- Written informed consent obtained from the patient/patient's legal guardian
- Diagnosis of SLE: Patients must have previously met ≥ 4 of the 11 revised ACR criteria
- Current background treatments may include the following medications prior to randomization: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and antimalarials, such as hydroxychloroquine ≤ 600 mg/day, and prednisone ≤ 20 mg daily (or an equivalent dose of another oral corticosteroid) for at least 28 days
Key exclusion criteria (34 listed)
- Weight ≥ 120 kg
- Use of cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil or cyclosporine within 28 days before study entry
- Use of doses of corticosteroids higher than the equivalent of prednisone 20 mg/day (or an equivalent dose of another corticosteroid) within 28 days before study entry
- In the opinion of the investigator, a likelihood of requiring initiation of immunosuppressant therapy (e.g., prednisone >20 mg daily (or an equivalent dose of another oral corticosteroid), azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, or dapsone) within the 28 days after study entry. Antimalarial dosing must be held constant during the study, but analgesics and NSAIDs may be varied.
- Current treatment with coumadin
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-5450.3 mg/kg IV (n=6) at Study Day 0 | Biological | 2 |
| MEDI 5450.3 mg/kg IV (n=6) at Study Day 0 | Biological | 1 |
| MEDI-5450.3 mg/kg IV (n=6) at Study Day 0 | Biological | 3 |
| MEDI-5450.3 mg/kg IV (n=6) at Study Day 0 | Biological | 4 |
| MEDI-5450.3 mg/kg IV (n=6) at Study Day 0 | Biological | 5 |
Primary outcome
Safety and tolerability of MEDI-545 will be assessed primarily by summarizing adverse events.
Time frame: Day 84
1 secondary outcome
Evaluation of MEDI-545 pharmacokinetics and possible immunogenicity
Time frame: Day 84
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 Dec 2007.
- Derived from this study: PubMed 33687069Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Derived from this study: PubMed 21798883Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, Robbie G, Levin R, Berney SM, Chindalore V, Olsen N, Richman L, Le C, Jallal B, White B; Lupus Interferon Skin Activity (LISA) Study Investigators. Safety profile and clinical activity of sifalimumab, a fully human anti-interferon alpha monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study. Ann Rheum Dis. 2011 Nov;70(11):1905-13. doi: 10.1136/ard.2010.144485. Epub 2011 Jul 27.
- Derived from this study: PubMed 19479852Yao Y, Richman L, Higgs BW, Morehouse CA, de los Reyes M, Brohawn P, Zhang J, White B, Coyle AJ, Kiener PA, Jallal B. Neutralization of interferon-alpha/beta-inducible genes and downstream effect in a phase I trial of an anti-interferon-alpha monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum. 2009 Jun;60(6):1785-96. doi: 10.1002/art.24557.
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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
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-545 and MEDI 545 in people with Lupus, run by MedImmune LLC at 21 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 7 inclusion and 34 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 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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. 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 primarily by summarizing adverse events. (time frame: Day 84). 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 NCT00299819, which also lists 3 linked publications.
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 Dec 2007.