Systemic Lupus ErythematosusPhase 2NCT00979654
A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
A Phase 2 study testing Sifalimumab in people with Systemic Lupus Erythematosus, run by MedImmune LLC at 28 sites in 4 countries.
Trial summary
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MI-CP179. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Sifalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 28 sitesin 4 countries
- Study dates
- Aug 2010to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at the time of screening.
- Written informed consent and any locally required authorization [example, Health Insurance Portability and Accountability Act (HIPAA) in the United States of America (USA), European Union (EU) Data Privacy Directive in the EU] obtained from the participant/legal representative prior to performing any protocol-related procedures, including Screening evaluations.
- Female participants of childbearing potential who are sexually active must use must use 2 effective methods of avoiding pregnancy from Screening, and must agree to continue using such precautions for 26 weeks after the final dose of investigational product.
- Males, unless surgically sterile, must use 2 effective methods of birth control with a female partner and must agree to continue using such contraceptive precautions from Screening until 26 weeks after the final dose of investigational product. If female, unless cervix has been surgically removed, have had a Pap smear with no evidence of malignancy within 6 months of baseline (defined as Day 1).
- Must have qualified for and received investigational product (sifalimumab or placebo) and completed the treatment period plus follow-up (through Day 266 for participants from MI-CP151 and MI-CP152 or through Day 168 for participants from MI-CP179) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179, ability to complete the study period through the final visit, willing to forego other forms of experimental drug treatment during the study.
Who cannot join
- Discontinued investigational product (sifalimumab) for safety reasons from any previous sifalimumab clinical study.
- For participants with systemic lupus erythematosus (SLE): Active severe or unstable neuropsychiatric SLE, that in the opinion of the investigator, would make the participant unsuitable for the study or unable to fully understand the informed consent, Active severe or unstable renal disease that in the opinion of the investigator would make the participant unsuitable for this study
- For participants with dermatomyositis (DM) or polymyositis (PM): Inclusion body myositis, cancer-associated myositis, myositis associated with another connective tissue disease, environmentally-associated myositis, or drug-related myopathy, a history of or a family history of non-inflammatory myopathy, scapular winging, atrophy, or hypertrophy of the calf muscles, Active Hepatitis A, confirmed positive tests for hepatitis B surface antigen (HbsAg) and hepatitis B core antibody (HbcAb) or hepatitis C serology. Isolated HbcAb positivity will be explored with additional reflex testing to determine eligibility.
- Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment, history of severe viral infection, such as disseminated herpes, herpes encephalitis, or ophthalmic herpes.
- Any of the following medications within 6 months before entry into the study: Leflunomide greater than (>) 20 milligram/day, Cyclophosphamide (or any other alkylating agent).
- Any of the following medications within 28 days before entry into the study: Prednisone or equivalent > 30 mg/day or > 0.5 mg/kg, whichever is the lesser amount, Cyclosporine at any dose, Thalidomide at any dose, Interferon alpha 2b, Hydroxychloroquine > 600 mg/day, Mycophenolate mofetil > 3 gram/day, Methotrexate > 25 mg/week, Azathioprine > 3 mg/kilogram (kg)/day, Combination of leflunomide and methotrexate
- Nonstable doses of one or more of the following medications within 28 days before entry into the study: Hydroxychloroquine, Mycophenolate mofetil, Methotrexate, Azathioprine
- At Screening blood tests (within 28 days before entry into the study), any of the following: Total bilirubin > upper limit of normal (ULN), Neutrophil count < 1,500/microliter (mcl) (or < 1.5 × 109/L), Platelet count < 60,000/microliter (mcl) (or < 60 × 109/L), Hemoglobin (Hgb) < 7 gram per decilitre (g/dL) (or < 70 g/L).
Trial locations and contacts
28 sites in 4 countries.
28 sites in 4 countries
United States24 sites
Research Site
Ann Arbor, Michigan
Research Site
Anniston, Alabama
Research Site
Baltimore, Maryland
Research Site
Boston, Massachusetts
Research Site
Charlotte, North Carolina
Research Site
Cincinnati, Ohio
Research Site
Colorado Springs, Colorado
Research Site
Columbia, South Carolina
Research Site
Cumberland, Maryland
Research Site
Dallas, Texas
Research Site
Duncansville, Pennsylvania
Research Site
Fort Lauderdale, Florida
Research Site
Houston, Texas
Research Site
Lake Success, New York
Research Site
Lansing, Michigan
Research Site
Manhasset, New York
Research Site
New York, New York
Research Site
Ocala, Florida
Research Site
Oklahoma City, Oklahoma
Research Site
Portland, Oregon
Research Site
San Leandro, California
Research Site
Scottsdale, Arizona
Research Site
Tampa, Florida
Research Site
Upland, California
About this study
Official title: A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or Myositis
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MI-CP179.
Read the detailed description
The primary objective of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adult participants with active SLE or DM or PM who were previously treated with investigational product (sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Sifalimumab
- Keywords
- Sifalimumab, MEDI-545
- 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.
SifalimumabDrug
All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.
| Study group | Role | What they receive |
|---|---|---|
| Sifalimumab (MEDI-545) 500 or 600 milligram (mg) | Experimental | All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment. Receives: Drug: Sifalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Measured: From start of study drug administration until week 182
Secondary outcomes (8)
Maximum Observed Serum Concentration (Cmax) for Sifalimumab
The Cmax is the maximum observed plasma concentration of sifalimumab.
Measured: Pre-infusion and End of Infusion on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab
The Tmax is the time to reach maximum observed plasma concentration of sifalimumab.
Measured: Pre-infusion and End of Infusion on Day 1
Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab
The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab.
Measured: Pre-infusion and End of Infusion on Day 1
Minimum Observed Serum Concentration (Ctrough) of Sifalimumab
The Ctrough is the minimum observed serum concentration of sifalimumab.
Measured: Pre-infusion and End of Infusion on Day 1
Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab
The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab.
Measured: Pre-infusion and End of Infusion on Day 1
Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab
The Ctrough is the minimum observed serum concentration at steady state of sifalimumab.
Measured: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168
Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab
The Ctrough is the minimum observed serum concentration of sifalimumab. Accumulation Index is calculated as Ctrough value at steady state divided by Ctrough value after first dose.
Measured: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168
Number of Participants With Positive Anti-Drug Antibody
Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study.
Measured: Day 1 and Week 12, 24, 52, 104, 156 and 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startAug 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Jerry Green, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979654
- Sponsor's protocol ID
- MI-CP212
- Status last verified
- Aug 2016
- First submitted
- 17 Sep 2009
- Last updated
- 27 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or Myositis
- ClinicalTrials.gov ID
- NCT00979654
- Acronym / sponsor ID
- MI-CP212
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Sifalimumab, MEDI-545
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Aug 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Posted 23 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MI-CP179.
Detailed description
The primary objective of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adult participants with active SLE or DM or PM who were previously treated with investigational product (sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sifalimumab (MEDI-545) 500 or 600 milligram (mg) | Experimental | Drug: SifalimumabAll participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older at the time of screening.
- Written informed consent and any locally required authorization [example, Health Insurance Portability and Accountability Act (HIPAA) in the United States of America (USA), European Union (EU) Data Privacy Directive in the EU] obtained from the participant/legal representative prior to performing any protocol-related procedures, including Screening evaluations.
- Female participants of childbearing potential who are sexually active must use must use 2 effective methods of avoiding pregnancy from Screening, and must agree to continue using such precautions for 26 weeks after the final dose of investigational product.
- Males, unless surgically sterile, must use 2 effective methods of birth control with a female partner and must agree to continue using such contraceptive precautions from Screening until 26 weeks after the final dose of investigational product. If female, unless cervix has been surgically removed, have had a Pap smear with no evidence of malignancy within 6 months of baseline (defined as Day 1).
- Must have qualified for and received investigational product (sifalimumab or placebo) and completed the treatment period plus follow-up (through Day 266 for participants from MI-CP151 and MI-CP152 or through Day 168 for participants from MI-CP179) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179, ability to complete the study period through the final visit, willing to forego other forms of experimental drug treatment during the study.
Key exclusion criteria (8 listed)
- Discontinued investigational product (sifalimumab) for safety reasons from any previous sifalimumab clinical study.
- For participants with systemic lupus erythematosus (SLE): Active severe or unstable neuropsychiatric SLE, that in the opinion of the investigator, would make the participant unsuitable for the study or unable to fully understand the informed consent, Active severe or unstable renal disease that in the opinion of the investigator would make the participant unsuitable for this study
- For participants with dermatomyositis (DM) or polymyositis (PM): Inclusion body myositis, cancer-associated myositis, myositis associated with another connective tissue disease, environmentally-associated myositis, or drug-related myopathy, a history of or a family history of non-inflammatory myopathy, scapular winging, atrophy, or hypertrophy of the calf muscles, Active Hepatitis A, confirmed positive tests for hepatitis B surface antigen (HbsAg) and hepatitis B core antibody (HbcAb) or hepatitis C serology. Isolated HbcAb positivity will be explored with additional reflex testing to determine eligibility.
- Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment, history of severe viral infection, such as disseminated herpes, herpes encephalitis, or ophthalmic herpes.
- Any of the following medications within 6 months before entry into the study: Leflunomide greater than (>) 20 milligram/day, Cyclophosphamide (or any other alkylating agent).
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 |
|---|---|---|
| SifalimumabAll participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment. | Drug | Sifalimumab (MEDI-545) 500 or 600 milligram (mg) |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From start of study drug administration until week 182
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
8 secondary outcomes
Maximum Observed Serum Concentration (Cmax) for Sifalimumab
Time frame: Pre-infusion and End of Infusion on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab
Time frame: Pre-infusion and End of Infusion on Day 1
Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab
Time frame: Pre-infusion and End of Infusion on Day 1
Minimum Observed Serum Concentration (Ctrough) of Sifalimumab
Time frame: Pre-infusion and End of Infusion on Day 1
Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab
Time frame: Pre-infusion and End of Infusion on Day 1
Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab
Time frame: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168
Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab
Time frame: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168
Number of Participants With Positive Anti-Drug Antibody
Time frame: Day 1 and Week 12, 24, 52, 104, 156 and 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jerry Green study director
MedImmune LLC
28 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sifalimumab in people with Systemic Lupus Erythematosus, run by MedImmune LLC at 28 sites in 4 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 5 inclusion and 8 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Brazil, Canada, Chile. 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 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?
Yes. Results are posted in the registry (first posted 23 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: From start of study drug administration until week 182). 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 27 Oct 2016.