A study to investigate the optimum dose, the efficacy and the safety of sifalimumab in adult patients with Systemic Lupus Erythematosus, a disease of the immune system
- Conditions
- Systemic Lupus ErythematosusMedDRA version: 14.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2010-024069-30-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
- 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 = 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
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- 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 laboratory abnormalities in the hepatic, renal or hematologic systems
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the efficacy of sifalimumab compared to placebo in subjects with chronic, moderately-to-severely active SLE.;Secondary Objective: - To evaluate the effect of sifalimumab compared to placebo in reducing background oral corticosteroids dosage, improving inflammatory cutaneous lupus lesions and fatigue.<br>- Safety<br>;Primary end point(s): The primary efficacy endpoint for this study is the proportion of subjects achieving a response in an SLE responder index [SRI (4)] at Day 365 in subjects with chronic moderately-to-severely active SLE.<br>;Timepoint(s) of evaluation of this end point: Day 365
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Additional secondary endpoints include comparison between sifalimumab and placebo groups on the proportion of subjects able<br>1. to reduce oral corticosteroids doses in subjects on =10 mg Prednisone equivalent at baseline <br>2. improve active inflammatory cutaneous lesions as measured by the CLASI <br>3. reduction in fatigue as measured by the Facit-Fatigue Scale<br><br>;Timepoint(s) of evaluation of this end point: Day 365