Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients

  • STATUS
    Recruiting
  • End date
    Oct 18, 2024
  • participants needed
    120
  • sponsor
    Novartis Pharmaceuticals
Updated on 9 June 2021
corticosteroids
DMARD
ds dna
anti-double stranded dna

Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 or CFZ533 in patients with SLE to enable further development of these compounds as treatment in this disease population

Details
Condition Autoimmune disease, CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases
Treatment CFZ533, VAY736, VAY736 Placebo, CFZ533 Placebo
Clinical Study IdentifierNCT03656562
SponsorNovartis Pharmaceuticals
Last Modified on9 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed
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 at a minimum either anti-double stranded DNA (anti-ds DNA) or anti-Ro (SSA) or anti-La (SSB) or anti-nuclear ribonucleoprotein (anti-RNP) or anti-Smith (anti-Sm)
Currently receiving corticosteroids and/or anti-malarial and/or thalidomide treatment and/or another DMARD on a stable dose according to protocol requirements
SLEDAI-2K score of 6 at screening
BILAG 2004 score of one "A" score either in the mucocutaneous or in the musculoskeletal domain or one "B" score in either the mucocutaneous or musculoskeletal domain and at least one "A" or "B" score in a second domain at screening
Weigh at least 40 kg at screening

Exclusion Criteria

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 activated partial thromboplastin time (aPTT) 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 other oral DMARD
Within 24 weeks: cyclophosphamide or biologics such as intravenous Ig, plasmapheresis, anti-TNF-a mAb, CTLA4-Fc Ig (abatacept) or BAFF targeting agents (e.g., belimumab)
Any B-cell depleting therapies (e.g., anti-CD20 mAb, anti-CD22 mAb, anti-CD52 mAb) or TACI-Ig (atacicept) administered within 52 weeks prior to screening, and a B-cell count <50 cells/ at the time of screening
Evidence of past exposure to 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
Presence of WHO Class III-IV renal involvement with proliferative disease Presence of severe lupus kidney disease as defined by proteinuria above 6 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.5 mg/dL (221.05 mol/L), or 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 2-month 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
Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Subjects who are HBsAg negative and HBcAb positive are excluded unless negative for HBV DNA. Once past screening and enrolled into study, requirements for monitoring and antiviral treatment are enacted
Subjects with a positive HCV antibody test should have HCV RNA levels
measured. Subjects with positive (detectable) HCV RNA should be excluded
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