A study to assess safety and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus
Phase 2
Completed
- Conditions
- systemic lupus erythematosus
- Registration Number
- jRCT2080224123
- Lead Sponsor
- Novartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 120
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Randomized, parallel cohort
- Primary Outcome Measures
Name Time Method SRI-4 index Week 29 a composite endpoint that incorporates SLEDAI-2K, BILAG 2004, and a visual analog scale of physician-rated disease activity
- Secondary Outcome Measures
Name Time Method Safety and tolerability Adverse events and serious adverse events
Pharmacokinetics PK concentrations in blood
Disease activity in SLE patients (Week 29) Week 29 A visual analog scale of patients -rated disease activity
Pharmacodynamics Total soluble CD40 in plasma
The effect to prevent disease flares BILAG-2004
Trial Locations
- Locations (1)
Japan/Asia except Japan/South America/Europe/Oceania
Location not specified
Japan/Asia except Japan/South America/Europe/Oceania