EUCTR2010-024069-30-BG
Active, not recruiting
Not Applicable
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AstraZeneca AB
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
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
Outcomes
Primary Outcomes
Not specified
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