A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults | Completed
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults
Health Conditions
  • Systemic Lupus Erythematosus
Completed
Recruitment Status
NCT01283139
Primary Trial ID Number
Summary
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
Primary Outcome Measures
  • Proportion of subjects achieving a response in an SLE responder index at Day 365; Day 365
Secondary Outcome Measures
    Sorry, this information is not available
Research Question
  • To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United States; Argentina; Brazil; Bulgaria; Canada; Chile; France; Germany; Hungary; India; Italy; Jamaica; Mexico; Netherlands; Peru; Philippines; Poland; Romania; South Africa; Spain; Thailand; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
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]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific Title
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
Secondary Trial Identifying Number
Sorry, this information is not available
Website
http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm; http://www.fda.gov/medwatch/safety.htm
Study Funded By
MedImmune LLC
Funder Type
Sorry, this information is not available
Study Sponsored By
MedImmune LLC
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

20 Jan 2011

Last Updated

14 Oct 2014

Date Record Refreshed on UKCTG

31 Jul 2015