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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Systemic Lupus Erythematosus
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruitment Status
Primary Trial ID Number
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
Research Details
    Sorry, this information is not available
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Drug : Sifalimumab, Drug : Sifalimumab, Drug : Sifalimumab, Drug : Placebo

Study Arm Groups : Treatment Arm 1, Treatment Arm 2, Treatment Arm 3, Treatment Arm 4

Intervention Type
See Interventions above
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
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Age Range
18 Years - 75 Years
Who Can Participate
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
Sanofi-Aventis Administrative Office
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Brazil, Bulgaria, Canada, Chile, France, Germany, Hungary, India, Italy, Jamaica, Mexico, Netherlands, Peru, Philippines, Poland, Romania, South Africa, Spain, Thailand, United Kingdom, United States
Scientific Title
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
MedImmune LLC
Key Dates

Recruitment Start Date

Mar 2011

Recruitment End Date

Nov 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

20 Jan 2011

Last Updated

14 Oct 2014