Lupus Erythematosus, SystemicPhase 2NCT00657189
A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus
A Phase 2 study testing MEDI-545 in people with Lupus Erythematosus, Systemic and Lupus, run by MedImmune LLC at 22 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic, Lupus
- What is being tested?
- MEDI-545
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 22 sitesUnited States
- Study dates
- Jul 2008to May 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥ 18 years at the time of the first dose of study drug;
- Written informed consent and HIPAA authorization (applies to covered entities in the US only) obtained from the subject or subject's legal representative;
- Meet at least 4 of the 11 revised ACR classification criteria for SLE
- Have positive antinuclear antibody test (ANA) at ≥ 1:80 serum dilution documented in the past or at screening;
- Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥ 6;
- Treatment for SLE with antimalarials, oral prednisone or another systemic corticosteroid, mycophenolate mofetil, methotrexate, leflunomide, azathioprine, or dapsone;
Show all 9Show fewer
- Women, unless surgically sterile or at least 2 years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) in addition to the use of condoms (male or female condoms with spermicide) from screening through the end of the study. Cessation of birth control after this point should be discussed with a responsible physician. Men unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) from Study Day 0 through the end of the study;
- Ability to complete the study period, including the follow-up period through Study Day 168; and
- Willing to forego other forms of experimental treatment during the study.
Who cannot join
- Have received MEDI-545 within 120 days prior to screening;
- History of allergy or reaction to any component of the study drug formulation;
- Have received the following medications within 28 days before randomization:
- Systemic cyclophosphamide at any dose
- Cyclosporine at any dose
- Thalidomide at any dose
Show all 42Show fewer
- Hydroxychloroquine > 600 mg/day
- Mycophenolate mofetil > 3 g/day
- Methotrexate > 25 mg/week
- Azathioprine > 3 mg/kg/day
- Have received fluctuating doses of the following within 28 days before randomization:
- Antimalarials
- Mycophenolate mofetil
- Methotrexate
- Leflunomide
- Azathioprine
- Dapsone
- Have received Leflunomide > 20mg/day in the 6 months prior to Study Day 0;
- Have received prednisone > 20 mg/day or in fluctuating doses within 14 days before randomization;
- Have received fluctuating doses of non-steroidal anti-inflammatory drugs within 14 days before randomization;
- Treatment with any investigational drug therapy within 28 days before randomization into the study, B cell-depleting therapies within 12 months before randomization, or biologic therapies within 30 days or 5 half-lives of the biologic agent, whichever is longer, before randomization into the study;
- In the investigator's opinion, evidence of clinically significant active infection, including ongoing, chronic infection, within 28 days before randomization;
- A history of severe viral infection as judged by the investigators, including severe infections of either cytomegalovirus or the herpes family such as disseminated herpes, herpes encephalitis, ophthalmic herpes;
- Herpes zoster infection within 3 months before randomization;
- Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening
- Vaccination with live attenuated viruses within 28 days before randomization;
- Pregnancy (women, unless surgically sterile or at least 2 years post-menopausal, must have a negative serum pregnancy test within 28 days before receiving the study drug and a negative urine pregnancy test on days of study drug administration before receiving the study drug);
- Breastfeeding or lactating women;
- History of primary immunodeficiency;
- History of alcohol or drug abuse < 1 year prior to randomization;
- 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);
- History of active tuberculosis (TB) infection or newly positive TB skin test (defined as a reaction ≥ 10 mm in diameter if not on systemic immunosuppressive medication or ≥ 5 mm if on systemic immunosuppressive medication;
- History of latent TB infection without completion of an appropriate course of treatment;
- Elective surgery planned from the time of screening through Study Day 168;
- At screening blood tests (within 28 days before randomization), any of the following:
- AST > 2.5 x upper limit of the normal range (ULN), unless caused by SLE
- ALT > 2.5 x ULN, unless caused by SLE
- Creatinine > 4.0 mg/dL
- Neutrophils < 1,500/mm3
- Platelet count < 50,000/mm3
- History of any disease, evidence of any current disease (other than SLE), any finding upon physical examination, or any laboratory abnormality that, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the study; or
- Any employee of the research site who is involved with the conduct of the study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Research Site
Anniston, Alabama, 36207
Research Site
Atlanta, Georgia, 30303
Research Site
Baltimore, Maryland, 21205
Research Site
Brooklyn, New York, 10003
Research Site
Charleston, South Carolina, 29406
Research Site
Charlotte, North Carolina, 28210
Research Site
Cincinnati, Ohio, 45219
Research Site
Clearwater, Florida, 33765-2616
Research Site
Colorado Springs, Colorado, 80910
Research Site
Columbia, South Carolina, 29204
Research Site
Decatur, Georgia, 30033
Research Site
Farmington, Connecticut, 06030-5353
Research Site
Houston, Texas, 77004
Research Site
Huntington Beach, California, 92646
Research Site
Lansing, Michigan, 48910
Research Site
Marrietta, Georgia, 30060
Research Site
Ocala, Florida, 34474
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Seattle, Washington, 98111
Research Site
Sugarland, Texas, 77479
Research Site
Upland, California, 91786
Research Site
West Fayetteville, Georgia, 30269
About this study
Official title: A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus
The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of multiple SC doses of MEDI-545 in subjects ≥ 18 years of age with moderately to severely active SLE despite standard of care.
- Conditions
- Lupus Erythematosus, Systemic, Lupus
- Being tested
- MEDI-545, Placebo
- Keywords
- Sifalimumab, MEDI-545, Lupus erythematosus, systemic
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-545Drug
100 mg once; SC Placebo × 12 doses on other weeks
MEDI-545Drug
100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
MEDI-545Drug
100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
MEDI-545Drug
100 mg every week × 13 doses
PlaceboDrug
SC Placebo every week × 13 doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-545 Receives: Drug: MEDI-545 |
| 2 | Experimental | MEDI-545 Receives: Drug: MEDI-545 |
| 3 | Experimental | MEDI-545 Receives: Drug: MEDI-545 |
| 4 | Experimental | MEDI-545 Receives: Drug: MEDI-545 |
| 5 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures.
Measured: Immediately following the first administration of study drug through Study Day 168.
Secondary outcomes (1)
A secondary endpoint of this study is to assess certain measures of disease activity including PK, and PD of SC doses of MEDI-545.
Measured: At Study Day 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Warren Greth, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657189
- Sponsor's protocol ID
- MI-CP179
- Status last verified
- Aug 2016
- First submitted
- 9 Apr 2008
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Merrill 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 21798883
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00657189
- Acronym / sponsor ID
- MI-CP179
- Conditions
- Lupus Erythematosus, Systemic, Lupus
- Keywords
- Sifalimumab, MEDI-545, Lupus erythematosus, systemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Apr 2008 (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 multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of multiple SC doses of MEDI-545 in subjects ≥ 18 years of age with moderately to severely active SLE despite standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-545MEDI-545 |
| 2 | Experimental | Drug: MEDI-545MEDI-545 |
| 3 | Experimental | Drug: MEDI-545MEDI-545 |
| 4 | Experimental | Drug: MEDI-545MEDI-545 |
| 5 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects ≥ 18 years at the time of the first dose of study drug;
- Written informed consent and HIPAA authorization (applies to covered entities in the US only) obtained from the subject or subject's legal representative;
- Meet at least 4 of the 11 revised ACR classification criteria for SLE
- Have positive antinuclear antibody test (ANA) at ≥ 1:80 serum dilution documented in the past or at screening;
- Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥ 6;
Key exclusion criteria (42 listed)
- Have received MEDI-545 within 120 days prior to screening;
- History of allergy or reaction to any component of the study drug formulation;
- Have received the following medications within 28 days before randomization:
- Have received fluctuating doses of the following within 28 days before randomization:
- Have received Leflunomide > 20mg/day in the 6 months prior to Study Day 0;
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-545100 mg once; SC Placebo × 12 doses on other weeks | Drug | 1 |
| MEDI-545100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks | Drug | 2 |
| MEDI-545100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks | Drug | 3 |
| MEDI-545100 mg every week × 13 doses | Drug | 4 |
| PlaceboSC Placebo every week × 13 doses | Drug | 5 |
Primary outcome
The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures.
Time frame: Immediately following the first administration of study drug through Study Day 168.
1 secondary outcome
A secondary endpoint of this study is to assess certain measures of disease activity including PK, and PD of SC doses of MEDI-545.
Time frame: At Study Day 98
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 9 Aug 2016.
- Results publication: 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.
Related trials for Lupus Erythematosus, Systemic
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Warren Greth, M.D. study director
MedImmune LLC
22 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-545 in people with Lupus Erythematosus, Systemic and Lupus, run by MedImmune LLC at 22 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 9 inclusion and 42 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 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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. 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?
The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures. (time frame: Immediately following the first administration of study drug through Study Day 168.). 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 NCT00657189, which also lists 1 linked publication.
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 9 Aug 2016.