A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults | Completed
A Study to Evaluate the Efficacy an... | Completed
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults

Trial Source

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

Medical Conditions
  • Systemic Lupus Erythematosus
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01283139
Primary Trial ID Number

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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
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
Interventional
Intervention
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - 75 Years
Who Can Participate
Patients
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Cambridge
Cambridgeshire
Local Institution
London
Greater London
Manchester
Sanofi-Aventis Administrative Office
Guildford
Leeds
Brighton
Cannock
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CD-IA-MEDI-545-1067
Sponsor(s)
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 added to source

20 Jan 2011

Date updated in source

14 Oct 2014