A study to assess safety and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus
- Conditions
- systemic lupus erythematosus
- Registration Number
- JPRN-jRCT2080224123
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 120
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
- 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
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Disease activity in SLE patients (Week 29)<br>SRI-4 index (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<br>Safety and tolerability<br>Adverse events and serious adverse events<br>efficacy<br>Disease activity in SLE patients (Week 29)<br>A visual analog scale of physician-rated disease activity<br>efficacy<br>Disease activity in SLE patients (Week 29)<br>A visual analog scale of patients -rated disease activity<br>pharmacokinetics<br>Pharmacokinetics<br>PK concentrations in blood<br>efficacy<br>The effect to prevent disease flares<br>BILAG-2004<br>pharmacodynamics<br>Pharmacodynamics<br>Total soluble CD40 in plasma