Sjogren's Syndrome
Conditions
Interventions
Regimen A - Continuous treatment of participants who were on 300 mg s.c. monthly treatment in either of the NEPTUNUS core studies, i.e., ianalumab 300 mg s.c. monthly.
Regimen B - Participants who wer
Sponsors
Maruyama Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent prior to participation in the extension study. 2.Participants must have participated in either one of the two NEPTUNUS core studies, CVAY736A2301 or CVAY736A2302, and must have completed the entire treatment up to Week 48 without treatment discontinuation in core NEPTUNUS studies. 3.In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy.
Exclusion criteria
Exclusion criteria: 1.Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols. 2.Plans for administration of live vaccines during the study period. 3.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test. 4.Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment during dosing and for 6 months after stopping of investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent AEs (TEAEs)/SAEs | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Greece, Hungary, Iceland, India, Israel, Italy, Japan, Lebanon, Mexico, Peru, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed