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

A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)

ClinicalTrials.gov Identifier: NCT03656562

Novartis Reference Number: CVAY736X2208

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Systemic Lupus Erythematosus (SLE)
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
120 participants
Start date 
Dec 19, 2018
Completion date 
Nov 30, 2023
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
VAY736
Powder for solution for injection
Drug
VAY736 Placebo
Solution for injection
Drug
CFZ533
Concentrate for solution for infusion
Drug
CFZ533 Placebo
Solution for infusion

Eligibility Criteria

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/μ 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 or nephrotic range proteinuria (above 2 g/day), corresponding to a urine protein creatinine ratio of approx. 200 mg/mmol or 1.77 g/g, currently 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.

Study Locations

Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As, C1015ABO
-
Argentina
Australia
Novartis Investigative Site
Recruiting
Clayton, 3168
Victoria
Australia
China
Novartis Investigative Site
Recruiting
Nanjing, 210008
Jiangsu
China
Czechia
Novartis Investigative Site
Recruiting
Praha 2, 128 50
-
Czechia
France
Novartis Investigative Site
Recruiting
Lille, 59000
-
France
Novartis Investigative Site
Recruiting
Marseille, 13003
-
France
Novartis Investigative Site
Recruiting
Paris Cedex 13, 75651
-
France
Novartis Investigative Site
Recruiting
Pessac Cedex, 33604
-
France
Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1023
-
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Israel
Novartis Investigative Site
Recruiting
Jerusalem,
-
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 5265601
-
Israel
Japan
Novartis Investigative Site
Recruiting
Nagoya, 457 8510
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya, 460-0001
Aichi
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku ku, 162 8655
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Suwon si, 16499
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Gwangju, 61469
-
Korea, Republic of
Poland
Novartis Investigative Site
Recruiting
Bydgoszcz, 85 168
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-218
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 00-874
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg, 620028
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint-Petersburg, 194044
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 190068
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Barcelona/ Cataluny/Espanya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08041
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40447
-
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40705
-
Taiwan
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
-
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10700
-
Thailand
Novartis Investigative Site
Recruiting
Chiang Mai, 50200
-
Thailand

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
+81337978748
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]