A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

The purpose of this study is to measure the long-term safety and tolerability of
ianalumab in participants with Sjogrens syndrome who have previously completed treatment
from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302).

- The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection.
All participants will receive ianalumab either monthly or every 3 months.

- The treatment duration will be 3 years with an additional up to 2-year safety
follow-up. The total duration of this extension study will be up to 5 years.

- The visit frequency will be monthly during both the treatment period and mandatory
follow-up, and then less frequently during the subsequent conditional follow-up

Treatment of interest: The randomized treatment (ianalumab) will be received monthly or
every 3 months. Participants assigned to treatment every 3 months will receive placebo
every month between the ianalumab doses to maintain blinding.

Number of Participants: Approximately 600 participants from the NEPTUNUS core studies
will be rolled over into the extension study.

Treatment Groups:There will be no screening period in this trial. From Week 48 of the
NEPTUNUS core study, participants will be given the opportunity to consent to this
extension study.

From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible
participants will be assigned to either one of the treatment regimens:

- ianalumab 300 mg monthly or

- ianalumab 300 mg once every 3 months Participants receiving placebo in either of the
NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or
every 3 months starting from Week 60 and participants receiving ianalumab in either
of the NEPTUNUS core studies will continue the same treatment in the extension
study.

Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe.
Participants will be given the opportunity to self-inject at home on some visits after
receiving training. The primary purpose of this 3-year treatment extension study is the continued evaluation
of the safety and tolerability of treatment with ianalumab 300 mg monthly or every 3
months. An additional purpose is to explore the long-term efficacy of both dosing
regimens of ianalumab 300 mg.

The Primary Objective is to assess the long-term safety and tolerability of ianalumab in
participants with Sjogrens syndrome. Secondary objectives are as follows, To evaluate the
long-term efficacy of VAY736 300 mg administered monthly or every 3 months.

To show comparability of ianalumab Ctrough between 2x 1mL PFS (from the NEPTUNUS core
studies: CVAY736A2301 and CVAY736A2302) and 1x 2mL PFS for participants on continuous
monthly treatment.

To further assess the pharmacokinetics of ianalumab. To assess the impact of long-term
treatment on B-cell depletion. Trial Design: This is a multicenter, randomized,
double-blind, phase 3b study to assess the long-term safety and tolerability of four
treatment regimens of ianalumab in participants with Sjogrens syndrome who have taken
part in and completed one of two NEPTUNUS core studies, NEPTUNUS-1 (CVAY736A2301) or
NEPTUNUS-2 (CVAY736A2302). There will be no screening period in this trial. From week 48
of the NEPTUNUS core study, participants will be given the opportunity to consent to this
extension study. Eligible participants will continue their assigned treatment to receive
ianalumab 300 mg either monthly or every 3 months for up to 3 additional years of
treatment beyond the 1-year core study period. After the treatment period, all
participants will enter a follow-up period to be monitored for at least 20 weeks and then
a conditional (if B-cell recovery criteria have not been met) follow-up period. The total
post treatment follow-up period is up to 2 years.

Study Population: Participants with Sjogrens syndrome who have completed treatment in one
of two NEPTUNUS core studies.

Method of blinding: Double-blind Study treatment assignment method: Participants
randomized to ianalumab 300 mg monthly or every 3 months in one of the NEPTUNUS core
studies will continue their assigned treatment. Participants randomized to placebo in the
NEPTUNUS core studies will be randomized in a 1:1 ratio to either ianalumab 300 mg
monthly or every 3 months.

Participants randomized to ianalumab 300 mg every 3 months will receive placebo (a dummy
treatment) once monthly between doses.

Committees: An independent Data Monitoring Committee (DMC) will be utilized for safety
review throughout the study. A steering committee will be formed to ensure overview of
the study conduct.