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A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01283139
First received: January 20, 2011
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).


Condition Intervention Phase
Systemic Lupus Erythematosus
 Drug: Sifalimumab
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

Resource links provided by NLM:

MedlinePlus related topics: Lupus
U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Proportion of subjects achieving a response in an SLE responder index at Day 365 [ Time Frame: Day 365 ] [ Designated as safety issue: No ]

Enrollment: 432
Study Start Date: April 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm 1 Drug: Sifalimumab
IV Sifalimumab (200 mg) every 2 weeks for 4 weeks and then monthly for 44 weeks
Experimental: Treatment Arm 2 Drug: Sifalimumab
IV Sifalimumab (600 mg) every 2 weeks for 4 weeks and then monthly for 44 weeks
Experimental: Treatment Arm 3 Drug: Sifalimumab
IV Sifalimumab (1200 mg) every 2 weeks for 4 weeks and then monthly for 44 weeks
Placebo Comparator: Treatment Arm 4 Drug: Placebo
IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283139

  Show 136 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Gabor Illei, MD MedImmune LLC
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01283139     History of Changes
Other Study ID Numbers: CD-IA-MEDI-545-1067
Study First Received: January 20, 2011
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
SLE
Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013