Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)
- Conditions
- Systemic lupus erythematosus (SLE)MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-001508-12-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 120
- Written informed consent must be obtained before any assessment is performed
- Male and female patients 18 to 75 years of age
- Fulfill =4 of the 11 American College of Rheumatology 1997 classification criteria for SLE
- Patient diagnosed with SLE for at least 6 months prior to screening
- Elevated serum titers at screening of ANA (=1:80) of a pattern consistent with an SLE diagnosis, including either anti-double stranded DNA (anti-ds DNA), anti-Ro (SSA), anti-La (SSB), anti-nuclear ribonucleoprotein (anti-RNP) or anti-Smith (anti-Sm)
- Currently receiving corticosteroids and/or antimalarials and/or another DMARD on a stable dose according to protocol requirements
- SLEDAI-2K score of =6 at screening
- BILAG 2004 score of =1A or =2B in mucocutaneous domain at screening
- Weigh at least 40 kg at screening
- Other protocol-defined inclusion criteria may apply
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Cohort 2 (CFZ533/Placebo) only:
- Patients who are at significant risk for thromboembolic events based on the following:
-- History of either thrombosis or 3 or more spontaneous abortions
-- Presence of lupus anticoagulant or significantly prolonged partial thromboplastin time (PTT) consistent with co-existent anti-phospholipid syndrome and without concurrent prophylactic treatment with aspirin or anticoagulants as per local standard of care
All Cohorts:
- History of receiving prior to screening:
-- Within 12 weeks: i.v. corticosteroids, calcineurin inhibitors or mycophenolate mofetil
-- Within 24 weeks: cyclophosphamide, intravenous Ig, plasmapheresis, anti-TNF-a mAb, CTLA4-Fc Ig (abatacept) or BAFF targeting agents (e.g., belimumab)
-- Any B-cell depleting therapies (administered >1 year ago) and with a Bcell count <50 cells/µL at time of screening; or, any B-cell depleting therapies within 52 weeks prior to screening
- Evidence of active tuberculosis as assessed by Quantiferon testing at screening
- Presence of human immunodeficiency virus (HIV) infection at screening
- Severe organ dysfunction or life threatening disease; ECOG performance status > 1 at screening
- History of WHO Class III-IV renal involvement with proliferative disease or nephrotic range proteinuria (above 2 g/day) requiring immune suppressive induction or maintenance treatment exceeding
protocol-defined limits
- Active viral, bacterial or other infections at the time of screening or enrollment
- Receipt of live/attenuated vaccine within a 2month period before first dosing
- Uncontrolled, co-existing serious disease, e.g., uncontrolled hypertension, heart failure, type I diabetes, thyroid disease within 3 months prior to first dosing, or significant, unresolved illness within 2
weeks prior to first dosing
- History of hypersensitivity to drugs of similar chemical class
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method