NCT03656562 is a Phase 2 clinical trial of VAY736 in Systemic Lupus Erythematosus (SLE), sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT03656562?

NCT03656562 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03656562?

Interventions in NCT03656562: VAY736, VAY736 Placebo, CFZ533, CFZ533 Placebo.

What condition does NCT03656562 study?

NCT03656562 studies Systemic Lupus Erythematosus (SLE).

Is NCT03656562 still recruiting?

NCT03656562 is currently completed. Last updated 7 October 2025.

Are results published for NCT03656562?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-07 · How we verify

NCT03656562

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 7 October 2025

What this trial tests

Phase 2 trial testing VAY736 in Systemic Lupus Erythematosus (SLE) in 107 participants. Completed in 28 April 2025.

Timeline

19 December 2018

Primary endpoint
27 July 2022

28 April 2025

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	107
Start date	19 December 2018
Primary completion	27 July 2022
Estimated completion	28 April 2025
Sites	31 locations across France, Japan, Russia, Taiwan, Germany, Hungary, Israel, Poland

Drugs / interventions tested

VAY736 — full drug profile →
VAY736 Placebo
CFZ533 — full drug profile →
CFZ533 Placebo

Conditions studied

Systemic Lupus Erythematosus (SLE) — all drugs for Systemic Lupus Erythematosus (SLE) →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Systemic Lupus Erythematosus (SLE). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29 Primary · Baseline, Week 17 to Week 29

The primary endpoint is 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 n

Group	Value	95% CI
Cohort 1 VAY736	15
Cohort 1 VAY736 Placebo	3
Cohort 2 CFZ533	8
Cohort 2 CFZ533 Placebo	6

Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity Secondary · Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29

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.

Week 5

Group	Value	95% CI
Cohort 1 VAY736	-7.6	± 14.27
Cohort 1 VAY736 Placebo	-5.6	± 13.76
Cohort 2 CFZ533	-8.3	± 12.04
Cohort 2 CFZ533 Placebo	-12.5	± 15.94

Week 9

Group	Value	95% CI
Cohort 1 VAY736	-17.4	± 18.72
Cohort 1 VAY736 Placebo	-10.9	± 13.54
Cohort 2 CFZ533	-9.3	± 15.73
Cohort 2 CFZ533 Placebo	-13.7	± 18.43

Week 13

Group	Value	95% CI
Cohort 1 VAY736	-23.0	± 19.51
Cohort 1 VAY736 Placebo	-13.6	± 16.72
Cohort 2 CFZ533	-19.4	± 16.70
Cohort 2 CFZ533 Placebo	-20.3	± 19.26

Week 17

Group	Value	95% CI
Cohort 1 VAY736	-26.2	± 19.14
Cohort 1 VAY736 Placebo	-14.2	± 16.38
Cohort 2 CFZ533	-21.9	± 21.81
Cohort 2 CFZ533 Placebo	-22.2	± 20.10

Week 21

Group	Value	95% CI
Cohort 1 VAY736	-28.1	± 20.27
Cohort 1 VAY736 Placebo	-17.9	± 16.24
Cohort 2 CFZ533	-26.1	± 23.15
Cohort 2 CFZ533 Placebo	-24.1	± 17.71

Week 25

Group	Value	95% CI
Cohort 1 VAY736	-33.2	± 19.63
Cohort 1 VAY736 Placebo	-18.6	± 17.62
Cohort 2 CFZ533	-28.5	± 22.92
Cohort 2 CFZ533 Placebo	-24.6	± 19.12

Week 29

Group	Value	95% CI
Cohort 1 VAY736	-32.8	± 20.74
Cohort 1 VAY736 Placebo	-19.4	± 16.04
Cohort 2 CFZ533	-28.7	± 22.89
Cohort 2 CFZ533 Placebo	-24.5	± 19.25

Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity Secondary · Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29

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.

Week 5

Group	Value	95% CI
Cohort 1 VAY736	-9.0	± 23.14
Cohort 1 VAY736 Placebo	-4.8	± 13.60
Cohort 2 CFZ533	-9.8	± 20.63
Cohort 2 CFZ533 Placebo	-3.8	± 19.33

Week 9

Group	Value	95% CI
Cohort 1 VAY736	-12.5	± 21.35
Cohort 1 VAY736 Placebo	-12.2	± 15.62
Cohort 2 CFZ533	-17.9	± 30.22
Cohort 2 CFZ533 Placebo	0.1	± 20.52

Week 13

Group	Value	95% CI
Cohort 1 VAY736	-15.7	± 21.69
Cohort 1 VAY736 Placebo	-8.8	± 17.75
Cohort 2 CFZ533	-21.8	± 31.01
Cohort 2 CFZ533 Placebo	-0.1	± 22.10

Week 17

Group	Value	95% CI
Cohort 1 VAY736	-12.7	± 24.19
Cohort 1 VAY736 Placebo	-8.0	± 19.27
Cohort 2 CFZ533	-26.7	± 28.92
Cohort 2 CFZ533 Placebo	1.6	± 19.05

Week 21

Group	Value	95% CI
Cohort 1 VAY736	-15.1	± 24.82
Cohort 1 VAY736 Placebo	-9.5	± 24.88
Cohort 2 CFZ533	-27.2	± 31.92
Cohort 2 CFZ533 Placebo	-0.5	± 24.79

Week 25

Group	Value	95% CI
Cohort 1 VAY736	-18.0	± 19.91
Cohort 1 VAY736 Placebo	-10.4	± 21.33
Cohort 2 CFZ533	-27.0	± 30.58
Cohort 2 CFZ533 Placebo	1.1	± 25.62

Week 29

Group	Value	95% CI
Cohort 1 VAY736	-18.1	± 21.81
Cohort 1 VAY736 Placebo	-9.0	± 24.64
Cohort 2 CFZ533	-27.8	± 33.41
Cohort 2 CFZ533 Placebo	-1.9	± 25.06

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are presented for the double-blind treatment period (from first dose of study treatment until Week 25) and for the open-label period (Week 29 until Week 49), including AE in follow-up period up to the cut-off date.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VAY736 (Double-blind)

Serious: 1/34 (3%)

Deaths: 0/34

VAY736 Placebo (Double-blind)

Serious: 4/33 (12%)

Deaths: 0/33

CFZ533 (Double-blind)

Serious: 0/20 (0%)

Deaths: 0/20

CFZ533 Placebo (Double-blind)

Serious: 1/20 (5%)

Deaths: 0/20

All Patients (Double-blind)

Serious: 6/107 (6%)

Deaths: 0/107

VAY736/VAY736 (Open-label)

Serious: 5/31 (16%)

Deaths: 0/31

VAY736 Placebo/VAY736 (Open-label)

Serious: 3/31 (10%)

Deaths: 0/31

CFZ533/CFZ533 (Open-label)

Serious: 0/20 (0%)

Deaths: 0/20

CFZ533 Placebo/CFZ533 (Open-label)

Serious: 3/16 (19%)

Deaths: 0/16

All Patients (Open-label)

Serious: 11/98 (11%)

Deaths: 0/98

Serious adverse events (23 terms)

Reaction	System	VAY736 (Double-blind)	VAY736 Placebo (Double-bli…	CFZ533 (Double-blind)	CFZ533 Placebo (Double-bli…	All Patients (Double-blind)	VAY736/VAY736 (Open-label)	VAY736 Placebo/VAY736 (Ope…	CFZ533/CFZ533 (Open-label)	CFZ533 Placebo/CFZ533 (Ope…	All Patients (Open-label)
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Vertigo positional	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Cytomegalovirus viraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumocystis jirovecii pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumonia bacterial	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumonia cytomegaloviral	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Salmonella bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Head injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Jaw fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Meniscus injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Spinal compression fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Spinal stenosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Central nervous system vasculitis	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Renal impairment	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—
Ovarian cyst	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—

Other adverse events (47 terms — click to expand)

Reaction	System	VAY736 (Double-blind)	VAY736 Placebo (Double-bli…	CFZ533 (Double-blind)	CFZ533 Placebo (Double-bli…	All Patients (Double-blind)	VAY736/VAY736 (Open-label)	VAY736 Placebo/VAY736 (Ope…	CFZ533/CFZ533 (Open-label)	CFZ533 Placebo/CFZ533 (Ope…	All Patients (Open-label)
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Injection related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Hypertriglyceridaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Blood immunoglobulin M decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Cytomegalovirus viraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Acute myocardial infarction, Vertigo positional, Pancreatitis, Cytomegalovirus viraemia, Herpes zoster, Pneumocystis jirovecii pneumonia, Pneumonia, Pneumonia bacterial.

Data from ClinicalTrials.gov NCT03656562 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

B cell depletion therapies in autoimmune disease: advances and mechanistic insights.
Lee DSW, Rojas OL, Gommerman JL. · · 2021 · cited 496× · PMID 33324003 · DOI 10.1038/s41573-020-00092-2
Molecular basis and therapeutic implications of CD40/CD40L immune checkpoint.
Tang T, Cheng X, Truong B, Sun L, et al · · 2021 · cited 201× · PMID 33091428 · DOI 10.1016/j.pharmthera.2020.107709
Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
Atherosclerosis With Immune Checkpoint Inhibitor Therapy: Evidence, Diagnosis, and Management: <i>JACC: CardioOncology</i> State-of-the-Art Review.
Suero-Abreu GA, Zanni MV, Neilan TG. · · 2022 · cited 67× · PMID 36636438 · DOI 10.1016/j.jaccao.2022.11.011
Emerging Therapies in Immune Thrombocytopenia.
Audia S, Bonnotte B, Bonnotte B. · · 2021 · cited 44× · PMID 33801294 · DOI 10.3390/jcm10051004
Cytokines as Biomarkers in Systemic Lupus Erythematosus: Value for Diagnosis and Drug Therapy.
Idborg H, Oke V. · · 2021 · cited 40× · PMID 34768756 · DOI 10.3390/ijms222111327
Systemic lupus erythematosus: pathogenesis and targeted therapy.
Su X, Yu H, Lei Q, Chen X, et al · · 2024 · cited 33× · PMID 39472388 · DOI 10.1186/s43556-024-00217-8
Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.
Veerasubramanian PK, Wynn TA, Quan J, Karlsson FJ. · · 2024 · cited 26× · PMID 39297883 · DOI 10.1084/jem.20240806

Verify or expand the search:

Other trials of VAY736

Trials testing the same drug.

NCT05349214 — Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome · Phase 3 · active not recruiting
NCT05350072 — Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome · Phase 3 · active not recruiting
NCT04903197 — Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lympho · Phase 1 · terminated
NCT03827798 — Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 2 · active not recruiting
NCT03400176 — VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib · Phase 1 · terminated

Other recruiting trials for Systemic Lupus Erythematosus (SLE)

Currently open trials in the same condition.

NCT07447986 — To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus · Phase 2 · recruiting
NCT07490041 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refr · EARLY_PHASE1 · recruiting
NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
NCT07332481 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease · Phase 3 · recruiting
NCT06875960 — A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Dis · Phase 4 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03656562 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 7 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03656562.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03656562

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (23 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of VAY736

Other recruiting trials for Systemic Lupus Erythematosus (SLE)

Other Novartis Pharmaceuticals trials

Verify against primary sources