A study to assess safety and preliminary clinical efficacy of VAY736 and CFZ533 in patients with 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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224123

Enrollment

120

Registered

2018-11-01

Start date

2018-12-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic lupus erythematosus

Interventions

investigational material(s) Generic name etc : VAY736 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Fulfill 4 or more of the 11 American College of Rheumatology 1997 classification criteria for SLE - SLEDAI-2K score of 6 or higher - BILAG 2004 score of 1A or higher, or 2B or higher in mucocutaneous domain

Exclusion criteria

Exclusion criteria: - Presence of WHO Class III-IV renal involvement with proliferative disease or nephrotic range proteinuria (above 2 g/day) requiring immune suppressive treatment exceeding protocol-defined limits - Active viral, bacterial or other infections, 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 Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
efficacy Disease activity in SLE patients (Week 29) SRI-4 index (a composite endpoint that incorporates SLEDAI-2K, BILAG 2004, and a visual analog scale of physician-rated disease activity)	—

Secondary

Measure	Time frame
safety Safety and tolerability Adverse events and serious adverse events efficacy Disease activity in SLE patients (Week 29) A visual analog scale of physician-rated disease activity efficacy Disease activity in SLE patients (Week 29) A visual analog scale of patients -rated disease activity pharmacokinetics Pharmacokinetics PK concentrations in blood efficacy The effect to prevent disease flares BILAG-2004 pharmacodynamics Pharmacodynamics Total soluble CD40 in plasma	—

Measure

Time frame

safety Safety and tolerability Adverse events and serious adverse events efficacy Disease activity in SLE patients (Week 29) A visual analog scale of physician-rated disease activity efficacy Disease activity in SLE patients (Week 29) A visual analog scale of patients -rated disease activity pharmacokinetics Pharmacokinetics PK concentrations in blood efficacy The effect to prevent disease flares BILAG-2004 pharmacodynamics Pharmacodynamics Total soluble CD40 in plasma

—

Countries

Asia except Japan, Europe, Japan, Oceania, South America

Contacts

Public ContactHideki Maruyama

Novartis Pharma K. K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026