Systemic Lupus Erythematosus (SLE)Phase 2NCT03656562
Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
A Phase 2 study testing VAY736 and CFZ533 in people with Systemic Lupus Erythematosus (SLE), run by Novartis Pharmaceuticals at 31 sites in 15 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- VAY736 and CFZ533
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 31 sitesin 15 countries
- Study dates
- 19 Dec 2018to 28 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 19Show fewer
- 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.
Trial locations and contacts
31 sites in 15 countries.
31 sites in 15 countries
Japan5 sites
Novartis Investigative Site
Chuo Ku, Tokyo, 104-8560
Novartis Investigative Site
Nagoya, Aichi-ken, 4578510
Novartis Investigative Site
Nagoya, Aichi-ken, 4600001
Novartis Investigative Site
Shinjuku Ku, Tokyo, 162-8655
Novartis Investigative Site
Shinjuku-ku, Tokyo, 1608582
China3 sites
Novartis Investigative Site
Guangzhou, Guangdong, 510000
Novartis Investigative Site
Nanjing, Jiangsu, 210008
Novartis Investigative Site
Shanghai, 200127
Poland3 sites
Novartis Investigative Site
Bydgoszcz, 85-168
Novartis Investigative Site
Poznan, 60-218
Novartis Investigative Site
Warsaw, 00-874
Russia3 sites
Novartis Investigative Site
Moscow, 115522
Novartis Investigative Site
Saint Petersburg, 194044
Novartis Investigative Site
Yekaterinburg, 620144
Taiwan3 sites
Novartis Investigative Site
Taichung, Taiwan ROC, 40201
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taichung, 407219
Germany2 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Hungary2 sites
Novartis Investigative Site
Budapest, 1023
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Spain2 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Barcelona, 08041
Thailand2 sites
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
About this study
Official title: 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)
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.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- VAY736, VAY736 Placebo, CFZ533, CFZ533 Placebo
- Keywords
- Systemic Lupus Erythematosus, SLE, Anti-CD40, anti-BAFF-receptor, B-cell depletion, BAFF-receptor blockade, ianalumab, VAY736, iscalimab, CFZ533
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAY736Drug
Also called Ianalumab
150 mg powder in vial for solution for injection; after reconstitution to 150 mg/mL per vial, a dose of 300 mg
VAY736 PlaceboDrug
Also called Ianalumab/Placebo
solution for injection; 0 mg/mL administered as 2 mL s.c. injection
CFZ533Drug
Also called Iscalimab
150 mg/mL as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion
CFZ533 PlaceboDrug
Also called Iscalimab/Placebo
Placebo as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 VAY736 | Experimental | 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. Receives: Drug: VAY736 |
| Cohort 1 VAY736 Placebo | Placebo comparator | 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. Receives: Drug: VAY736; Drug: VAY736 Placebo |
| Cohort 2 CFZ533 | Experimental | 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. Receives: Drug: CFZ533 |
| Cohort 2 CFZ533 Placebo | Placebo comparator | 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. Receives: Drug: CFZ533; Drug: CFZ533 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 17 to Week 29
Secondary outcomes (8)
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.
Measured: Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29
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.
Measured: Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29
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).
Measured: Up to 69 weeks
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
Measured: Up to 69 weeks
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.
Measured: Weeks 29, 53, 69, and EoS (up to 69 weeks), pre-dose
PK Cohort 2 - Free CFZ533 Concentration in Plasma
Measured: Weeks 29, 53, and 69, pre-dose
PD Cohort 2 (CFZ533): Total Soluble CD40
Measured: Weeks 29, 53, and 69
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.
Measured: Baseline, Weeks 29, 53, 69, and EoS (up to 69 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start19 Dec 2018
- Primary completion27 Jul 2022
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656562
- Sponsor's protocol ID
- CVAY736X2208
- Other IDs
- 2018-001508-12, 2018
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2018
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT03656562
- Acronym / sponsor ID
- CVAY736X2208
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- Systemic Lupus Erythematosus, SLE, Anti-CD40, anti-BAFF-receptor, B-cell depletion, BAFF-receptor blockade, ianalumab, VAY736
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 VAY736 | Experimental | Drug: VAY736Blinded 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. |
| Cohort 1 VAY736 Placebo | Placebo comparator | Drug: VAY736, Drug: VAY736 PlaceboBlinded 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. |
| Cohort 2 CFZ533 | Experimental | Drug: CFZ533Blinded 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. |
| Cohort 2 CFZ533 Placebo | Placebo comparator | Drug: CFZ533, Drug: CFZ533 PlaceboBlinded 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
- History of receiving prior to screening:
- Within 12 weeks: i.v. corticosteroids, calcineurin inhibitors or other oral DMARD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAY736Also: Ianalumab150 mg powder in vial for solution for injection; after reconstitution to 150 mg/mL per vial, a dose of 300 mg | Drug | Cohort 1 VAY736, Cohort 1 VAY736 Placebo |
| VAY736 PlaceboAlso: Ianalumab/Placebosolution for injection; 0 mg/mL administered as 2 mL s.c. injection | Drug | Cohort 1 VAY736 Placebo |
| CFZ533Also: Iscalimab150 mg/mL as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion | Drug | Cohort 2 CFZ533, Cohort 2 CFZ533 Placebo |
| CFZ533 PlaceboAlso: Iscalimab/PlaceboPlacebo as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion | Drug | Cohort 2 CFZ533 Placebo |
Primary outcome
Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29
Time frame: Baseline, Week 17 to Week 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
8 secondary outcomes
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Time frame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Time frame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29
Percentage of Participants With Flare
Time frame: Up to 69 weeks
Time to First Flare
Time frame: Up to 69 weeks
Pharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration
Time frame: Weeks 29, 53, 69, and EoS (up to 69 weeks), pre-dose
PK Cohort 2 - Free CFZ533 Concentration in Plasma
Time frame: Weeks 29, 53, and 69, pre-dose
PD Cohort 2 (CFZ533): Total Soluble CD40
Time frame: Weeks 29, 53, and 69
Percentage of Participants With Anti-drug Antibodies (ADAs)
Time frame: Baseline, Weeks 29, 53, 69, and EoS (up to 69 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
31 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAY736 and CFZ533 in people with Systemic Lupus Erythematosus (SLE), run by Novartis Pharmaceuticals at 31 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Japan, China, Poland, Russia, Taiwan and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29 (time frame: Baseline, Week 17 to Week 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.