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Health Condition(s) or Problem
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Systemic Lupus Erythematosus
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Lay Summary
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To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with
moderately to severely active Systemic Lupus Erythematosus (SLE).
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Fulfills at least 4 of ACR criteria for SLE including a positive ANA or elevated
dsDNA or Sm antibody at screening
- Disease history of SLE = 24 weeks at screening
- Weight > 40 kg
- Currently receiving stable dose of oral prednisone and/or
antimalarials/immunosuppressives
- Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI)
and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global
Assessment
- No evidence of cervical malignancy on PAP within 6 months of randomization
- Female subjects must be willing to avoid pregnancy
- Negative TB test or newly positive TB test due to latent TB for which treatment must
be initiated at or before randomization
Exclusion Criteria:
- Active severe SLE-driven renal disease or unstable renal disease prior to screening
- Active severe or unstable neuropsychiatric SLE
- Clinically significant active infection including ongoing and chronic infections
- History of HIV
- Confirmed Positive tests for Hepatitis B or positive test for hepatitis C
- History of severe herpes infection such as herpes encephalitis, ophthalmic herpes,
disseminated herpes
- Herpes Zoster within 3 months of screening
- History of cancer other than basal cancer or cervical cancer treated with apparent
success= 1 year prior to randomization
- Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic
and/or clinical effect (whichever is longer) prior to screening
- Live or attenuated vaccine within 4 weeks prior to screening
- Subjects with substance abuse
- Subjects with significant hematologic abnormalities
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Who cannot enter the trial
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Inclusion Criteria:
- Fulfills at least 4 of ACR criteria for SLE including a positive ANA or elevated
dsDNA or Sm antibody at screening
- Disease history of SLE = 24 weeks at screening
- Weight > 40 kg
- Currently receiving stable dose of oral prednisone and/or
antimalarials/immunosuppressives
- Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI)
and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global
Assessment
- No evidence of cervical malignancy on PAP within 6 months of randomization
- Female subjects must be willing to avoid pregnancy
- Negative TB test or newly positive TB test due to latent TB for which treatment must
be initiated at or before randomization
Exclusion Criteria:
- Active severe SLE-driven renal disease or unstable renal disease prior to screening
- Active severe or unstable neuropsychiatric SLE
- Clinically significant active infection including ongoing and chronic infections
- History of HIV
- Confirmed Positive tests for Hepatitis B or positive test for hepatitis C
- History of severe herpes infection such as herpes encephalitis, ophthalmic herpes,
disseminated herpes
- Herpes Zoster within 3 months of screening
- History of cancer other than basal cancer or cervical cancer treated with apparent
success= 1 year prior to randomization
- Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic
and/or clinical effect (whichever is longer) prior to screening
- Live or attenuated vaccine within 4 weeks prior to screening
- Subjects with substance abuse
- Subjects with significant hematologic abnormalities
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What will happen
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Drug; Sifalimumab; IV Sifalimumab (200 mg) every 2 weeks for 4 weeks and then monthly for 44 weeks; Treatment Arm 1; Drug; Sifalimumab; IV Sifalimumab (600 mg) every 2 weeks for 4 weeks and then monthly for 44 weeks; Treatment Arm 2; Drug; Sifalimumab; IV Sifalimumab (1200 mg) every 2 weeks for 4 weeks and then monthly for 44 weeks; Treatment Arm 3; Drug; Placebo; IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks; Treatment Arm 4
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Primary aim
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Proportion of subjects achieving a response in an SLE responder index at Day 365
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Secondary Aim
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Sorry, not currently available
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm; http://www.fda.gov/medwatch/safety.htm
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Recruitment Status
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Not Recruiting
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Nation
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England
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Location
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Guildford, Brighton, Cambridge, Cannock, Leeds, London, Manchester, Newcastle Upon Tyne
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