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CompletedNCT03656562Updated May 14, 2026Results posted

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

A Phase 2 interventional study of VAY736 and VAY736 Placebo in Systemic Lupus Erythematosus (SLE), sponsored by Novartis Pharmaceuticals. Completed at 31 sites in 15 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

The study consisted of a 28-day screening period, a blinded treatment period of 28 weeks where randomized patients received treatment with investigational drug (ianalumab or iscalimab) or placebo. At the end of Week 29 visit, the patients entered the open-label treatment phase where patients in active treatment group continued to receive active treatment and patients in placebo group started active treatment with ianalumab/iscalimab until Week 49. After completion of the open-label treatment period, all patients entered a Follow-Up period in order to monitor safety and efficacy up to Week 69. The Week 69 visit was the End of Study (EoS) visit for patients in Cohort 2 (CFZ533). Study duration for patients in Cohort 2 was approximately 18 months. For Cohort 1 (VAY736), patients who did not achieve B-cell recovery by Week 69 Visit entered into a Secondary Follow-Up period until achieving B cell recovery criteria (B-cell count was at >= 50 cells/µl or at least 80% of baseline levels). Safety follow-up visits were scheduled as deemed appropriate until the patient achieved the B-cell recovery criteria, followed by an EoS 4 weeks later.

02

Conditions studied

  • Systemic Lupus Erythematosus (SLE)

Keywords

  • Systemic Lupus Erythematosus
  • SLE
  • Anti-CD40
  • anti-BAFF-receptor
  • B-cell depletion
  • BAFF-receptor blockade
  • ianalumab
  • VAY736
  • iscalimab
  • CFZ533
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 107 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 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 μmol/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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    Cohort 1 VAY736

    Blinded treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.

    Drug: VAY736

  • Placebo comparator
    Cohort 1 VAY736 Placebo

    Blinded treatment phase: VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label treatment phase: VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.

    Drug: VAY736 · Drug: VAY736 Placebo

  • Experimental
    Cohort 2 CFZ533

    Blinded treatment phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.

    Drug: CFZ533

  • Placebo comparator
    Cohort 2 CFZ533 Placebo

    Blinded treatment phase: CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE). Open-label phase: CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.

    Drug: CFZ533 · Drug: CFZ533 Placebo

Interventions

  • DrugVAY736

    150 mg powder in vial for solution for injection; after reconstitution to 150 mg/mL per vial, a dose of 300 mg

    Also known as: Ianalumab

  • DrugVAY736 Placebo

    solution for injection; 0 mg/mL administered as 2 mL s.c. injection

    Also known as: Ianalumab/Placebo

  • DrugCFZ533

    150 mg/mL as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion

    Also known as: Iscalimab

  • DrugCFZ533 Placebo

    Placebo as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion

    Also known as: Iscalimab/Placebo

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29

    The primary endpoint was a composite of SRI-4 response at Week 29 with sustained reduction in oral corticosteroid from Week 17 through Week 29. Patients taking other rescue medication or prohibited medication or drop out before Week 29 were considered non-responders. SRI-4 response is defined as below: * having \>= 4 points reduction from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (score is 0 to 105; a higher score indicating more severe disease) AND * no new British Isles Lupus Activity Group (BILAG)-2004 A organ domain score and no more than one new BILAG-2004 B organ domain scores compared with baseline AND * \<10 mm point increase from baseline with scale 0 to 100 mm in the physician's global assessment from baseline Sustained reduction in oral corticosteroid is defined as below: * =\< 5 mg/day or less than or equal to baseline dose, whichever was lower at Week 17 AND * no increase of that dose from Week 17 through Week 29

    Time frame: Baseline, Week 17 to Week 29

Secondary outcomes

  1. Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity

    The Physician's global assessment (PhGA-VAS) of disease activity was performed using 100 mm VAS ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.

    Time frame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29

  2. Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity

    The patient's global assessment of disease activity was performed using a Visual Analogue Scale (VAS) of 100 mm ranging from "no disease activity" (score 0) to "severe disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.

    Time frame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29

  3. Percentage of Participants With Flare

    Flare was defined as one new 'A' score or two or more 'B' scores using the British Isles Lupus Assessment Group Index (BILAG -2004).

    Time frame: Up to 69 weeks

  4. Time to First Flare

    Time to first flare, with flare defined as one new 'A' score or two or more 'B' score using BILAG -2004

    Time frame: Up to 69 weeks

  5. Pharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration

    Note: End of study (EoS) was a floating timepoint and did not represent a uniform timepoint across the study.

    Time frame: Weeks 29, 53, 69, and EoS (up to 69 weeks), pre-dose

  6. PK Cohort 2 - Free CFZ533 Concentration in Plasma

    Time frame: Weeks 29, 53, and 69, pre-dose

  7. PD Cohort 2 (CFZ533): Total Soluble CD40

    Time frame: Weeks 29, 53, and 69

  8. Percentage of Participants With Anti-drug Antibodies (ADAs)

    ADAs were measured in plasma for CFZ533 and in serum for VAY736. Note: End of study (EoS) was a floating timepoint and did not represent a uniform timepoint across the study.

    Time frame: Baseline, Weeks 29, 53, 69, and EoS (up to 69 weeks)

07

Results

Posted Jun 6, 2024

Participant flow

Participant flow — Overall Study
MilestoneCohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Started34332020
Pharmacodynamic analysis set34332020
Safety set34332020
Pharmacokinetic analysis set34302016
Completed26212017
Not completed81203
Withdrew: Physician decision3500
Withdrew: Subject decision5703

Outcome measures

PrimaryPercentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29

The primary endpoint was a composite of SRI-4 response at Week 29 with sustained reduction in oral corticosteroid from Week 17 through Week 29. Patients taking other rescue medication or prohibited medication or drop out before Week 29 were considered non-responders. SRI-4 response is defined as below: * having \>= 4 points reduction from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (score is 0 to 105; a higher score indicating more severe disease) AND * no new British Isles Lupus Activity Group (BILAG)-2004 A organ domain score and no more than one new BILAG-2004 B organ domain scores compared with baseline AND * \<10 mm point increase from baseline with scale 0 to 100 mm in the physician's global assessment from baseline Sustained reduction in oral corticosteroid is defined as below: * =\< 5 mg/day or less than or equal to baseline dose, whichever was lower at Week 17 AND * no increase of that dose from Week 17 through Week 29

Time frame:
Baseline, Week 17 to Week 29
Reported as:
Count of participants · Participants
Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29
ParticipantsCohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 2915386
SecondaryChanges Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity

The Physician's global assessment (PhGA-VAS) of disease activity was performed using 100 mm VAS ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.

Time frame:
Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29
Reported as:
Mean · Unit on a scale
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Unit on a scaleCohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Week 5 n=34,33,20,20-7.6 ± 14.27-5.6 ± 13.76-8.3 ± 12.04-12.5 ± 15.94
Week 9 n=33,33,20,19-17.4 ± 18.72-10.9 ± 13.54-9.3 ± 15.73-13.7 ± 18.43
Week 13 n=33,33,20,19-23.0 ± 19.51-13.6 ± 16.72-19.4 ± 16.70-20.3 ± 19.26
Week 17 n=34,31,20,19-26.2 ± 19.14-14.2 ± 16.38-21.9 ± 21.81-22.2 ± 20.10
Week 21 n=34,33,19,18-28.1 ± 20.27-17.9 ± 16.24-26.1 ± 23.15-24.1 ± 17.71
Week 25 n=33,32,19,18-33.2 ± 19.63-18.6 ± 17.62-28.5 ± 22.92-24.6 ± 19.12
Week 29 n=33,32,20,17-32.8 ± 20.74-19.4 ± 16.04-28.7 ± 22.89-24.5 ± 19.25
SecondaryChanges Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity

The patient's global assessment of disease activity was performed using a Visual Analogue Scale (VAS) of 100 mm ranging from "no disease activity" (score 0) to "severe disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.

Time frame:
Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29
Reported as:
Mean · Unit on a scale
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Unit on a scaleCohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Week 5 n=34,32,20,20-9.0 ± 23.14-4.8 ± 13.60-9.8 ± 20.63-3.8 ± 19.33
Week 9 n=33,33,20,19-12.5 ± 21.35-12.2 ± 15.62-17.9 ± 30.220.1 ± 20.52
Week 13 n=32,33,20,19-15.7 ± 21.69-8.8 ± 17.75-21.8 ± 31.01-0.1 ± 22.10
Week 17 n=34,31,20,19-12.7 ± 24.19-8.0 ± 19.27-26.7 ± 28.921.6 ± 19.05
Week 21 n=34,32,19,18-15.1 ± 24.82-9.5 ± 24.88-27.2 ± 31.92-0.5 ± 24.79
Week 25 n=33,32,19,18-18.0 ± 19.91-10.4 ± 21.33-27.0 ± 30.581.1 ± 25.62
Week 29 n=33,32,20,17-18.1 ± 21.81-9.0 ± 24.64-27.8 ± 33.41-1.9 ± 25.06
SecondaryPercentage of Participants With Flare

Flare was defined as one new 'A' score or two or more 'B' scores using the British Isles Lupus Assessment Group Index (BILAG -2004).

Time frame:
Up to 69 weeks
Reported as:
Number · percentage of participants
Percentage of Participants With Flare
percentage of participantsCohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Double-blind Treatment (<=29 Weeks) n=34,33,20,208.830.32010
Open-label Treatment n=33,32,20,1609.4100
Post-treatment Follow-up n=32,30,20,163.13.350
SecondaryTime to First Flare

Time to first flare, with flare defined as one new 'A' score or two or more 'B' score using BILAG -2004

Time frame:
Up to 69 weeks
Reported as:
Mean · days
Time to First Flare
daysCohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Double-blind Treatment (<=29 Weeks) n=3,10,4,294.7 ± 89.80107.7 ± 34.23113.0 ± 68.6169.0 ± 19.80
Open-label Treatment n=0,3,2,0—301.3 ± 17.79379.0 ± 11.31—
Post-treatment Follow-up n=1,1,1,0419.0 ± NA484.0 ± NA421.0 ± NA—
SecondaryPharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration

Note: End of study (EoS) was a floating timepoint and did not represent a uniform timepoint across the study.

Time frame:
Weeks 29, 53, 69, and EoS (up to 69 weeks), pre-dose
Reported as:
Mean · μg/mL
Pharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration
μg/mLCohort 1 VAY736Cohort 1 VAY736 Placebo
Week 29 n=29,261.85 ± 1.170 ± 0
Week 53 n=22,231.68 ± 1.302.24 ± 1.45
Week 69 n=26,230.03 ± 0.140 ± 0
EoS n=13,130 ± 00 ± 0
SecondaryPK Cohort 2 - Free CFZ533 Concentration in Plasma
Time frame:
Weeks 29, 53, and 69, pre-dose
Reported as:
Mean · μg/mL
PK Cohort 2 - Free CFZ533 Concentration in Plasma
μg/mLCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Week 29 n=20,759.9 ± 40.30 ± 0
Week 53 n=20,956.9 ± 39.642.5 ± 20
Week 69 n=18,110 ± 00 ± 0
SecondaryPD Cohort 2 (CFZ533): Total Soluble CD40
Time frame:
Weeks 29, 53, and 69
Reported as:
Mean · ng/mL
PD Cohort 2 (CFZ533): Total Soluble CD40
ng/mLCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Week 29143 ± 44.40.365 ± 0.504
Week 53158 ± 36.1124 ± 67
Week 693 ± 3.891.38 ± 0.892
SecondaryPercentage of Participants With Anti-drug Antibodies (ADAs)

ADAs were measured in plasma for CFZ533 and in serum for VAY736. Note: End of study (EoS) was a floating timepoint and did not represent a uniform timepoint across the study.

Time frame:
Baseline, Weeks 29, 53, 69, and EoS (up to 69 weeks)
Reported as:
Number · percentage of participants
Percentage of Participants With Anti-drug Antibodies (ADAs)
percentage of participantsCohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 Placebo
Baseline n=30,29,19,1726.521.200
Week 29 n=30,30,20,175.921.200
Week 53 n=29,28,20,1506.300
Week 69 n=26,28,18,149.413.300
EoS n=19,16,0,011.89.1——

Adverse events

Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VAY7360/34 (0%)1/34 (2.9%)21/34 (61.8%)
VAY736 Placebo0/33 (0%)4/33 (12.1%)21/33 (63.6%)
CFZ5330/20 (0%)0/20 (0%)9/20 (45%)
CFZ533 Placebo0/20 (0%)1/20 (5%)11/20 (55%)
Total (Double-blind)0/107 (0%)6/107 (5.6%)62/107 (57.9%)
VAY736/VAY7360/33 (0%)3/33 (9.1%)15/33 (45.5%)
VAY736 Placebo/VAY7360/32 (0%)1/32 (3.1%)21/32 (65.6%)
CFZ533/CFZ5330/20 (0%)0/20 (0%)7/20 (35%)
CFZ533 Placebo/CFZ5330/16 (0%)2/16 (12.5%)14/16 (87.5%)
Total (Open-label)0/101 (0%)6/101 (5.9%)57/101 (56.4%)
VAY736/VAY736 (Post-treatment Follow-up)0/32 (0%)1/32 (3.1%)4/32 (12.5%)
VAY736 Placebo/VAY736 (Post-treatment Follow-up)0/30 (0%)1/30 (3.3%)6/30 (20%)
CFZ533/CFZ533 (Post-treatment Follow-up)0/20 (0%)0/20 (0%)2/20 (10%)
CFZ533 Placebo/CFZ533 (Post-treatment Follow-up)0/16 (0%)2/16 (12.5%)5/16 (31.3%)
Total (Post-treatment Follow-up)0/98 (0%)4/98 (4.1%)17/98 (17.3%)
VAY736/VAY736 (Secondary Post-treatment Follow-up)0/29 (0%)1/29 (3.4%)8/29 (27.6%)
VAY736 Placebo/VAY736 (Secondary Post-treatment Follow-up)0/25 (0%)1/25 (4%)5/25 (20%)
Total (Secondary Post-treatment Follow-up)0/54 (0%)2/54 (3.7%)13/54 (24.1%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventVAY736VAY736 PlaceboCFZ533CFZ533 PlaceboTotal (Double-blind)VAY736/VAY736VAY736 Placebo/VAY736CFZ533/CFZ533CFZ533 Placebo/CFZ533Total (Open-label)VAY736/VAY736 (Post-treatment Follow-up)VAY736 Placebo/VAY736 (Post-treatment Follow-up)CFZ533/CFZ533 (Post-treatment Follow-up)CFZ533 Placebo/CFZ533 (Post-treatment Follow-up)Total (Post-treatment Follow-up)VAY736/VAY736 (Secondary Post-treatment Follow-up)VAY736 Placebo/VAY736 (Secondary Post-treatment Follow-up)Total (Secondary Post-treatment Follow-up)
Cytomegalovirus viraemiaInfections and infestations0/340/330/200/200/1070/330/320/200/160/1010/320/300/201/161/980/290/250/54
Pneumocystis jirovecii pneumoniaInfections and infestations0/340/330/200/200/1070/330/320/200/160/1010/320/300/201/161/980/290/250/54
PneumoniaInfections and infestations0/340/330/200/200/1070/330/320/200/160/1010/320/300/201/161/980/290/250/54
Pneumonia bacterialInfections and infestations0/340/330/200/200/1070/330/320/201/161/1010/320/300/200/160/980/290/250/54
Pneumonia cytomegaloviralInfections and infestations0/340/330/200/200/1070/330/320/200/160/1010/320/300/201/161/980/290/250/54
Head injuryInjury, poisoning and procedural complications0/340/330/200/200/1070/330/320/201/161/1010/320/300/200/160/980/290/250/54
SyncopeNervous system disorders0/340/330/200/200/1070/330/320/201/161/1010/320/300/200/160/980/290/250/54
Respiratory failureRespiratory, thoracic and mediastinal disorders0/340/330/200/200/1070/330/320/200/160/1010/320/300/201/161/980/290/250/54
Carcinoid tumour of the stomachNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/340/330/201/201/1070/330/320/200/160/1010/320/300/200/160/980/290/250/54
Central nervous system vasculitisNervous system disorders0/340/330/200/200/1070/330/320/200/160/1010/320/300/200/160/980/291/251/54
Most frequent other events
Showing 10 of 46
Most frequent other events
EventVAY736VAY736 PlaceboCFZ533CFZ533 PlaceboTotal (Double-blind)VAY736/VAY736VAY736 Placebo/VAY736CFZ533/CFZ533CFZ533 Placebo/CFZ533Total (Open-label)VAY736/VAY736 (Post-treatment Follow-up)VAY736 Placebo/VAY736 (Post-treatment Follow-up)CFZ533/CFZ533 (Post-treatment Follow-up)CFZ533 Placebo/CFZ533 (Post-treatment Follow-up)Total (Post-treatment Follow-up)VAY736/VAY736 (Secondary Post-treatment Follow-up)VAY736 Placebo/VAY736 (Secondary Post-treatment Follow-up)Total (Secondary Post-treatment Follow-up)
Injection site reactionGeneral disorders9/341/330/200/2010/1076/3312/320/200/1618/1010/320/300/200/160/980/290/250/54
HeadacheNervous system disorders3/341/335/201/2010/1071/331/322/201/165/1010/320/300/200/160/982/290/252/54
NasopharyngitisInfections and infestations7/347/333/202/2019/1075/331/324/203/1613/1011/321/301/200/163/984/291/255/54
VertigoEar and labyrinth disorders1/340/330/201/202/1070/330/320/202/162/1010/320/300/200/160/980/290/250/54
Dry eyeEye disorders0/340/330/200/200/1070/330/321/202/163/1010/320/300/200/160/980/290/250/54
COVID-19Infections and infestations1/341/330/200/202/1072/331/321/200/164/1010/320/300/200/160/983/291/254/54
DiarrhoeaGastrointestinal disorders0/342/331/202/205/1070/330/320/200/160/1010/320/300/201/161/981/290/251/54
PyrexiaGeneral disorders2/340/332/200/204/1070/331/321/200/162/1010/320/300/200/160/981/290/251/54
CellulitisInfections and infestations0/341/330/202/203/1070/331/320/200/161/1010/321/300/200/161/980/291/251/54
Upper respiratory tract infectionInfections and infestations3/341/331/202/207/1071/331/320/200/162/1010/320/300/200/160/980/290/250/54

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Cohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 PlaceboTotal
Mean42.0 ± 10.9139.2 ± 10.4637.4 ± 11.3444.7 ± 12.4740.8 ± 11.29
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 PlaceboTotal
Female3227201998
Male26019
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort 1 VAY736Cohort 1 VAY736 PlaceboCohort 2 CFZ533Cohort 2 CFZ533 PlaceboTotal
Asian91271240
Black or African American00101
White252112866
08

Study locations

31 sites
  • Novartis Investigative Site
    Caba, C1015ABO, Argentina
  • Novartis Investigative Site
    Clayton, Victoria 3168, Australia
  • Novartis Investigative Site
    Guangzhou, Guangdong 510000, China
  • Novartis Investigative Site
    Nanjing, Jiangsu 210008, China
  • Novartis Investigative Site
    Shanghai, 200127, China
  • Novartis Investigative Site
    Prague, 128 00, Czechia
  • Novartis Investigative Site
    Pessac, 33604, France
  • Novartis Investigative Site
    Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
  • Novartis Investigative Site
    Berlin, 10117, Germany
  • Novartis Investigative Site
    Debrecen, Hajdu Bihar Megye 4032, Hungary
  • Novartis Investigative Site
    Budapest, 1023, Hungary
  • Novartis Investigative Site
    Ramat Gan, 5265601, Israel
  • Novartis Investigative Site
    Nagoya, Aichi-ken 4578510, Japan
  • Novartis Investigative Site
    Nagoya, Aichi-ken 4600001, Japan
  • Novartis Investigative Site
    Chuo Ku, Tokyo 104-8560, Japan
  • Novartis Investigative Site
    Shinjuku Ku, Tokyo 162-8655, Japan
  • Novartis Investigative Site
    Shinjuku-ku, Tokyo 1608582, Japan
  • Novartis Investigative Site
    Bydgoszcz, 85-168, Poland
  • Novartis Investigative Site
    Poznan, 60-218, Poland
  • Novartis Investigative Site
    Warsaw, 00-874, Poland
  • Novartis Investigative Site
    Moscow, 115522, Russia
  • Novartis Investigative Site
    Saint Petersburg, 194044, Russia
  • Novartis Investigative Site
    Yekaterinburg, 620144, Russia
  • Novartis Investigative Site
    Gwangju, 61469, South Korea
  • Novartis Investigative Site
    Barcelona, 08035, Spain
  • Novartis Investigative Site
    Barcelona, 08041, Spain
  • Novartis Investigative Site
    Taichung, Taiwan ROC 40201, Taiwan
  • Novartis Investigative Site
    Taichung, 40447, Taiwan
  • Novartis Investigative Site
    Taichung, 407219, Taiwan
  • Novartis Investigative Site
    Bangkok, 10400, Thailand
  • Novartis Investigative Site
    Bangkok, 10700, Thailand
09

References and documents

Study documents

  • Study protocol · Feb 11, 2025
  • Statistical analysis plan · Jun 5, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03656562
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 4, 2018
Start date
Dec 19, 2018
Primary completion
Jul 27, 2022
Completion
Apr 28, 2025
Results posted
Jun 6, 2024
Last update
May 14, 2026

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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