Clinical Trials List
Protocol NumberCVAY736X2208
Completed
2018-12-01 - 2024-05-16
Phase II
Recruiting3
ICD-10M32.9
Systemic lupus erythematosus, unspecified
ICD-9710.0
Systemic lupus erythematosus
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)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- HSIN-HUA CHEN Division of Rheumatology
- 林靖才 Division of Rheumatology
- 謝佳偉 Division of Rheumatology
- 曾智偉 Division of Rheumatology
- 謝祖怡 Division of Rheumatology
- 洪維廷 Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
- Yi-Ming Chen Division of Rheumatology
- 吳沂達 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 黃建中 風濕免疫科
- Chen Der-Yuan 風濕免疫科
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
3 Recruiting
Condition/Disease
systemic lupus erythematosus (SLE)
Objectives
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
Test Drug
VAY736 (ianalumab)、CFZ533 (iscalimab)
Active Ingredient
CFZ533 (iscalimab)
VAY736 (ianalumab)
VAY736 (ianalumab)
Dosage Form
VAY736: Powder for solution for injection
CFZ533: Concentrate for solution for infusion
CFZ533: Concentrate for solution for infusion
Dosage
VAY736 (ianalumab): 150mg/ vial
CFZ533 (iscalimab): 150mg/ 1ml/ vial
CFZ533 (iscalimab): 150mg/ 1ml/ vial
Endpoints
Primary Objective(s)
The primary objective of this study is to determine the effect of VAY736 and of CFZ533 versus their respective placebo on disease activity in SLE patients using the SRI-4 index.
Secondary Objectives
To assess safety and tolerability of VAY736 and of CFZ533 in patients
with SLE by recording all adverse events
To determine the change from baseline in the Physicians’ Global
Assessment (PhGA) at Week 29 in VAY736-, CFZ533- or their
respective placebo-treated arms by using a visual analogue scale (VAS)
To determine the change from baseline in the Patient's Global
Assessment (PGA) at Week 29 in VAY736, CFZ533 or their respective placebo-treated arms by using a patients VAS
To determine the pharmacokinetics (PK) of multiple doses of VAY736 (s.c.) and CFZ533 (i.v.) in SLE patients by analyzing PK concentrations in blood
To assess the effect of VAY736 and of CFZ533 versus their respective placebo to prevent disease flares in SLE patient’s using BILAG-2004
To evaluate the immunogenicity of multiple doses of VAY736 (s.c.) or CFZ533 (i.v.) in SLE patients by analyzing anti-drug antibodies in blood
To evaluate the pharmacodynamics (PD; rate, extent and duration of target engagement) of multiple doses of CFZ533 in SLE patients by analyzing total soluble CD40 in plasma
The primary objective of this study is to determine the effect of VAY736 and of CFZ533 versus their respective placebo on disease activity in SLE patients using the SRI-4 index.
Secondary Objectives
To assess safety and tolerability of VAY736 and of CFZ533 in patients
with SLE by recording all adverse events
To determine the change from baseline in the Physicians’ Global
Assessment (PhGA) at Week 29 in VAY736-, CFZ533- or their
respective placebo-treated arms by using a visual analogue scale (VAS)
To determine the change from baseline in the Patient's Global
Assessment (PGA) at Week 29 in VAY736, CFZ533 or their respective placebo-treated arms by using a patients VAS
To determine the pharmacokinetics (PK) of multiple doses of VAY736 (s.c.) and CFZ533 (i.v.) in SLE patients by analyzing PK concentrations in blood
To assess the effect of VAY736 and of CFZ533 versus their respective placebo to prevent disease flares in SLE patient’s using BILAG-2004
To evaluate the immunogenicity of multiple doses of VAY736 (s.c.) or CFZ533 (i.v.) in SLE patients by analyzing anti-drug antibodies in blood
To evaluate the pharmacodynamics (PD; rate, extent and duration of target engagement) of multiple doses of CFZ533 in SLE patients by analyzing total soluble CD40 in plasma
Inclution Criteria
Fulfill ≥4 of the 11 American College of Rheumatology 1997 classification
criteria for SLE at screening
Patient diagnosed with SLE for at least 6 months
Elevated serum titers at screening of ANA (≥1:80) in a pattern consistent with
an SLE diagnosis, including 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 anti-malarials and/or another
DMARD according to the following:
corticosteroids as single standard-of-care medication: an oral dose of
≤30 mg/day of prednisone or equivalent for a minimum of 8 weeks prior
to randomisation and at a stable dose for ≥2 weeks prior to
randomisation
corticosteroids not as a single standard-of-care medication: a stable oral
dose of ≤30 mg/day prednisone or equivalent for ≥2 weeks prior to
randomisation
an anti-malarial and/or one of the DMARDs: methotrexate or an
imidazole derivative (e.g., azathioprine, mizoribine) for a minimum of
12 weeks prior to screening and at a stable dose for ≥8 weeks prior to
randomisation. Combination of other DMARDs is not permitted
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
criteria for SLE at screening
Patient diagnosed with SLE for at least 6 months
Elevated serum titers at screening of ANA (≥1:80) in a pattern consistent with
an SLE diagnosis, including 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 anti-malarials and/or another
DMARD according to the following:
corticosteroids as single standard-of-care medication: an oral dose of
≤30 mg/day of prednisone or equivalent for a minimum of 8 weeks prior
to randomisation and at a stable dose for ≥2 weeks prior to
randomisation
corticosteroids not as a single standard-of-care medication: a stable oral
dose of ≤30 mg/day prednisone or equivalent for ≥2 weeks prior to
randomisation
an anti-malarial and/or one of the DMARDs: methotrexate or an
imidazole derivative (e.g., azathioprine, mizoribine) for a minimum of
12 weeks prior to screening and at a stable dose for ≥8 weeks prior to
randomisation. Combination of other DMARDs is not permitted
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
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 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
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 as
listed in the inclusion criterion 6
Active viral, bacterial or other infections at the time of screening or
enrollment, or history of recurrent clinically significant infection or of recurrent
bacterial infections with encapsulated organisms
Receipt of live/attenuated vaccine within a 2-month period before first dosing
Pregnant or nursing (lactating) women
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
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 as
listed in the inclusion criterion 6
Active viral, bacterial or other infections at the time of screening or
enrollment, or history of recurrent clinically significant infection or of recurrent
bacterial infections with encapsulated organisms
Receipt of live/attenuated vaccine within a 2-month period before first dosing
Pregnant or nursing (lactating) women
The Estimated Number of Participants
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Taiwan
9 participants
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Global
120 participants
