A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus.
- Conditions
- Health Condition 1: null- Systemic Lupus ErythematosusHealth Condition 2: M329- Systemic lupus erythematosus, unspecified
- Registration Number
- CTRI/2012/06/002731
- Lead Sponsor
- MedImmune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, one of which must be:
a) Significantly positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at central lab; OR
b) Elevated anti-dsDNA or Sm antibody at screening as determined by central lab
Disease history of SLE less or equal 24 weeks at screening
Weight less than 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
Females with an intact cervix must have no evidence of cervical malignancy documented on a Pap smear with 6 months of baseline
Females must be willing to avoid pregnancy throughout the study including the 180 day follow-up safety period
Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization
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 less or equal 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 laboratory abnormalities in the hepatic, renal or hematologic systems
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint for this study is the proportion of subjects achieving a response in an SLE responder index SRI (4) in subjects with chronic, moderately-to-severely active SLETimepoint: At Day 365 (Week 52)
- Secondary Outcome Measures
Name Time Method Secondary endpoints include comparison between sifalimumab and placebo groups on the proportion of subjects able to reduce oral corticosteroids doses in subjects on more or equal 10 mg Prednisone equivalent at baseline, <br/ ><br> to improve active inflammatory cutaneous lesions as measured by the CLASI, to reduction in fatigue as measured by the Facit-Fatigue Scale <br/ ><br>Timepoint: At Day 365 (Week 52)