xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05985915</url>
    </required_header>
    <id_info>
      <org_study_id>CVAY736A2301E1</org_study_id>
      <secondary_id>2022-502966-26</secondary_id>
      <nct_id>NCT05985915</nct_id>
    </id_info>
    <brief_title>A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.</brief_title>
    <acronym>NEPTUNUS-Ext</acronym>
    <official_title>A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to measure the long-term safety and tolerability of ianalumab in&#xD;
        participants with Sjogrens syndrome who have previously completed treatment from one of two&#xD;
        NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302).&#xD;
  &#xD;
          -  The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection. All&#xD;
             participants will receive ianalumab either monthly or every 3 months.&#xD;
  &#xD;
          -  The treatment duration will be 3 years with an additional up to 2-year safety follow-up.&#xD;
             The total duration of this extension study will be up to 5 years.&#xD;
  &#xD;
          -  The visit frequency will be monthly during both the treatment period and mandatory&#xD;
             follow-up, and then less frequently during the subsequent conditional follow-up&#xD;
  &#xD;
        Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every&#xD;
        3 months. Participants assigned to treatment every 3 months will receive placebo every month&#xD;
        between the ianalumab doses to maintain blinding.&#xD;
  &#xD;
        Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be&#xD;
        rolled over into the extension study.&#xD;
  &#xD;
        Treatment Groups:There will be no screening period in this trial. From Week 48 of the&#xD;
        NEPTUNUS core study, participants will be given the opportunity to consent to this extension&#xD;
        study.&#xD;
  &#xD;
        From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible&#xD;
        participants will be assigned to either one of the treatment regimens:&#xD;
  &#xD;
          -  ianalumab 300 mg monthly or&#xD;
  &#xD;
          -  ianalumab 300 mg once every 3 months Participants receiving placebo in either of the&#xD;
             NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or&#xD;
             every 3 months starting from Week 60 and participants receiving ianalumab in either of&#xD;
             the NEPTUNUS core studies will continue the same treatment in the extension study.&#xD;
  &#xD;
        Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe.&#xD;
        Participants will be given the opportunity to self-inject at home on some visits after&#xD;
        receiving training.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary purpose of this 3-year treatment extension study is the continued evaluation of&#xD;
        the safety and tolerability of treatment with ianalumab 300 mg monthly or every 3 months. An&#xD;
        additional purpose is to explore the long-term efficacy of both dosing regimens of ianalumab&#xD;
        300 mg.&#xD;
  &#xD;
        The Primary Objective is to assess the long-term safety and tolerability of ianalumab in&#xD;
        participants with Sjogrens syndrome. Secondary objectives are as follows, To evaluate the&#xD;
        long-term efficacy of VAY736 300 mg administered monthly or every 3 months.&#xD;
  &#xD;
        To show comparability of ianalumab Ctrough between 2x 1mL PFS (from the NEPTUNUS core&#xD;
        studies: CVAY736A2301 and CVAY736A2302) and 1x 2mL PFS for participants on continuous monthly&#xD;
        treatment.&#xD;
  &#xD;
        To further assess the pharmacokinetics of ianalumab. To assess the impact of long-term&#xD;
        treatment on B-cell depletion. Trial Design: This is a multicenter, randomized, double-blind,&#xD;
        phase 3b study to assess the long-term safety and tolerability of four treatment regimens of&#xD;
        ianalumab in participants with Sjogrens syndrome who have taken part in and completed one of&#xD;
        two NEPTUNUS core studies, NEPTUNUS-1 (CVAY736A2301) or NEPTUNUS-2 (CVAY736A2302). There will&#xD;
        be no screening period in this trial. From week 48 of the NEPTUNUS core study, participants&#xD;
        will be given the opportunity to consent to this extension study. Eligible participants will&#xD;
        continue their assigned treatment to receive ianalumab 300 mg either monthly or every 3&#xD;
        months for up to 3 additional years of treatment beyond the 1-year core study period. After&#xD;
        the treatment period, all participants will enter a follow-up period to be monitored for at&#xD;
        least 20 weeks and then a conditional (if B-cell recovery criteria have not been met)&#xD;
        follow-up period. The total post treatment follow-up period is up to 2 years.&#xD;
  &#xD;
        Study Population: Participants with Sjogrens syndrome who have completed treatment in one of&#xD;
        two NEPTUNUS core studies.&#xD;
  &#xD;
        Method of blinding: Double-blind Study treatment assignment method: Participants randomized&#xD;
        to ianalumab 300 mg monthly or every 3 months in one of the NEPTUNUS core studies will&#xD;
        continue their assigned treatment. Participants randomized to placebo in the NEPTUNUS core&#xD;
        studies will be randomized in a 1:1 ratio to either ianalumab 300 mg monthly or every 3&#xD;
        months.&#xD;
  &#xD;
        Participants randomized to ianalumab 300 mg every 3 months will receive placebo (a dummy&#xD;
        treatment) once monthly between doses.&#xD;
  &#xD;
        Committees: An independent Data Monitoring Committee (DMC) will be utilized for safety review&#xD;
        throughout the study. A steering committee will be formed to ensure overview of the study&#xD;
        conduct.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 22, 2023</start_date>
    <completion_date type="Anticipated">July 18, 2030</completion_date>
    <primary_completion_date type="Anticipated">August 21, 2028</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Treatment-emergent AEs (TEAEs)/SAEs</measure>
      <time_frame>Week 52 to Week 304</time_frame>
      <description>Assessment of Safety and tolerability of ianalumab (VAY736) in patients with active Sjogrens syndrome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ESSDAI change from baseline</measure>
      <time_frame>Over time up to Week 204</time_frame>
      <description>EULAR Sjogren's syndrome disease activity index (ESSDAI) is a validated clinical disease outcome measure for Sjogrens that will be used in the study The instrument contains 12 organ-specific domains contributing to assessment of disease activity. For each domain, features of disease activity are scored by a clinician in 3 or 4 (Level 0=No disease activity to Level 3= high disease activity) levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The maximum possible score is 123.To calculate ESSDAI, all 12 organ domains must be individually assessed by a trained assessor (study Investigator) at every scheduled timepoint. This is to evaluate the long-term efficacy of VAY736 300 mg administered monthly or every 3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants achieving ESSPRI ≤ 3 AND ≥ 1.5 points reduction from baseline</measure>
      <time_frame>Over time up to Week 204</time_frame>
      <description>The EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) questionnaire consists of three items to be given an activity level score between 0-10: pain (joint and/or muscle pain), fatigue and dryness (0 = no symptom at all and 10 = worst symptom imaginable&#xD;
  ESSPRI is an established disease outcome measure for Sjogrens. It consists of three domains of dryness, pain and fatigue. The participant will assess severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as a mean of scores from the three scales: (dryness + pain + fatigue) /3.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants achieving meaningful improvement in the SSSD score</measure>
      <time_frame>Over time up to Week 204</time_frame>
      <description>The Sjogrens Syndrome Symptom Diary (SSSD) is questionnaire consists of five (six for females) questions about symptoms of Sjögren's syndrome, each question given a score of 0-10 (0=no symptoms, 10=worst possible symptoms) where patient choose the one response that best describes how severe the symptom was at its worst in the PAST 24 HOURS. It includes six symptom items (eye dryness, mouth dryness, skin dryness, physical fatigue, muscle and/or joint pain, genital dryness), and applies a recall period of 24 hrs. The aim of the SSSD is to establish patient reported endpoints for the treatment of Sjogrens syndrome. Participants will complete the diary daily for 7 days prior to the scheduled dosing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pre-dose Ianalumab serum concentrations</measure>
      <time_frame>pre-dose (i.e., Ctrough) at Week 52 and Week 64</time_frame>
      <description>To show comparability of ianalumab Ctrough between 2x 1 mL PFS (from the NEPTUNUS core studies: CVAY736A2301 and CVAY736A2302) and 1x 2 mL PFS for participants on continuous monthly treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>On-treatment Ianalumab serum concentrations</measure>
      <time_frame>During treatment (e.g., Ctrough) i.e. from Week 52 to Week 204 and follow-up i.e. 304, after last dose.</time_frame>
      <description>To further assess the pharmacokinetics of ianalumab.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>B-cell count measurement</measure>
      <time_frame>Week 52 to Week 304</time_frame>
      <description>To assess impact of long-term treatment on B-cell depletion.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Sjogrens Syndrome</condition>
    <arm_group>
      <arm_group_label>Ianalumab Monthly</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ianalumab 300 mg s.c. monthly</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ianalumab 3 Monthly</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ianalumab 300 mg s.c. every three months</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ianalumab (VAY736)</intervention_name>
      <description>VAY736 300 mg /2 mL, PFS, Solution for injection for subcutaneous use</description>
      <arm_group_label>Ianalumab 3 Monthly</arm_group_label>
      <arm_group_label>Ianalumab Monthly</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo 0 mg/2 mL, PFS, Solution for injection for subcutaneous Use</description>
      <arm_group_label>Ianalumab 3 Monthly</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed informed consent prior to participation in the extension study.&#xD;
  &#xD;
            2. Participants must have participated in either one of the two NEPTUNUS core studies,&#xD;
               CVAY736A2301 or CVAY736A2302, and must have completed the entire treatment up to Week&#xD;
               48 without treatment discontinuation in core NEPTUNUS studies.&#xD;
  &#xD;
            3. In the judgement of the Investigator, participants must be expected to clinically&#xD;
               benefit from continued ianalumab therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols (see&#xD;
               NEPTUNUS studies protocols exclusion criteria in Section 5.2 for details).&#xD;
  &#xD;
            2. Plans for administration of live vaccines during the study period.&#xD;
  &#xD;
            3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
               female after conception and until the termination of gestation, confirmed by a&#xD;
               positive human Chorionic Gonadotropin (hCG) laboratory test.&#xD;
  &#xD;
            4. Women of child-bearing potential (WOCBP), defined as all women physiologically capable&#xD;
               of becoming pregnant, unless they are using highly effective methods of contraception&#xD;
               while taking study treatment during dosing and for 6 months after stopping of&#xD;
               investigational drug. Highly effective contraception methods include:&#xD;
  &#xD;
                 -  Total abstinence (when this is in line with the preferred and usual lifestyle of&#xD;
                    the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal,&#xD;
                    post-ovulation methods) and withdrawal are not acceptable methods of&#xD;
                    contraception.&#xD;
  &#xD;
                 -  Female bilateral tubal ligation, female sterilization (have had surgical&#xD;
                    bilateral oophorectomy with or without hysterectomy) or total hysterectomy at&#xD;
                    least six weeks before taking study treatment. In case of oophorectomy alone,&#xD;
                    only when the reproductive status of the woman has been confirmed by follow up&#xD;
                    hormone level assessment.&#xD;
  &#xD;
                 -  Male sterilization (at least 6 months prior to screening). For female&#xD;
                    participants on the study, the vasectomized male partner should be the sole&#xD;
                    partner for that participant.&#xD;
  &#xD;
                 -  Use of oral (estrogen and progesterone), injected, or implanted hormonal methods&#xD;
                    of contraception or placement of an intrauterine device (IUD) or intrauterine&#xD;
                    system (IUS), or other forms of hormonal contraception that have comparable&#xD;
                    efficacy (failure rate &lt; 1%), for example hormone vaginal ring or transdermal&#xD;
                    hormone contraception.&#xD;
  &#xD;
               In case of use of oral contraception women should have been stable on the same pill&#xD;
               for a minimum of 3 months before taking study treatment.&#xD;
  &#xD;
               Contraception should be used in accordance with locally approved prescribing&#xD;
               information of concomitant medications administered.&#xD;
  &#xD;
               Women are considered post-menopausal if they have had 12 months of natural&#xD;
               (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate&#xD;
               history of vasomotor symptoms). Women are considered of not child-bearing potential if&#xD;
               they are post-menopausal or have had surgical bilateral oophorectomy (with or without&#xD;
               hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago.&#xD;
               In the case of oophorectomy alone, only when the reproductive status of the woman has&#xD;
               been confirmed by follow-up hormone level assessment is she considered not of&#xD;
               child-bearing potential.&#xD;
  &#xD;
               If local regulations deviate from the contraception methods listed above to prevent&#xD;
               pregnancy, local regulations apply and will be described in the informed consent form&#xD;
               (ICF).&#xD;
  &#xD;
            5. Sexually active males unless they agree to use barrier protection during intercourse&#xD;
               while taking study treatment are excluded. As condom use alone has a reported failure&#xD;
               rate exceeding 1% per year, it is recommended female partners of male study&#xD;
               participants use a second method of birth control. Although ianalumab is not&#xD;
               teratogenic and/or genotoxic, and not transferred to semen, male contraception is&#xD;
               required, as requested by FDA.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Novartis Pharmaceuticals</last_name>
      <phone>1-888-669-6682</phone>
      <email>novartis.email@novartis.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Novartis Pharmaceuticals</last_name>
      <phone>+41613241111</phone>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sjogrens Syndrome</keyword>
    <keyword>ianalumab</keyword>
    <keyword>VAY736</keyword>
    <keyword>NEPTUNUS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sjogren's Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
  This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05985915
  org study id: CVAY736A2301E1
  secondary id: 2022-502966-26
  nct id: NCT05985915
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of Treatment-emergent AEs (TEAEs)/SAEs
  time frame: Week 52 to Week 304
  description: Assessment of Safety and tolerability of ianalumab (VAY736) in patients with active Sjogrens syndrome
  measure: ESSDAI change from baseline
  time frame: Over time up to Week 204
  description: EULAR Sjogren's syndrome disease activity index (ESSDAI) is a validated clinical disease outcome measure for Sjogrens that will be used in the study The instrument contains 12 organ-specific domains contributing to assessment of disease activity. For each domain, features of disease activity are scored by a clinician in 3 or 4 (Level 0=No disease activity to Level 3= high disease activity) levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The maximum possible score is 123.To calculate ESSDAI, all 12 organ domains must be individually assessed by a trained assessor (study Investigator) at every scheduled timepoint. This is to evaluate the long-term efficacy of VAY736 300 mg administered monthly or every 3 months.
  measure: Proportion of participants achieving ESSPRI ≤ 3 AND ≥ 1.5 points reduction from baseline
  time frame: Over time up to Week 204
  description: The EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) questionnaire consists of three items to be given an activity level score between 0-10: pain (joint and/or muscle pain), fatigue and dryness (0 = no symptom at all and 10 = worst symptom imaginable
  ESSPRI is an established disease outcome measure for Sjogrens. It consists of three domains of dryness, pain and fatigue. The participant will assess severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as a mean of scores from the three scales: (dryness + pain + fatigue) /3.
  measure: Proportion of participants achieving meaningful improvement in the SSSD score
  time frame: Over time up to Week 204
  description: The Sjogrens Syndrome Symptom Diary (SSSD) is questionnaire consists of five (six for females) questions about symptoms of Sjögren's syndrome, each question given a score of 0-10 (0=no symptoms, 10=worst possible symptoms) where patient choose the one response that best describes how severe the symptom was at its worst in the PAST 24 HOURS. It includes six symptom items (eye dryness, mouth dryness, skin dryness, physical fatigue, muscle and/or joint pain, genital dryness), and applies a recall period of 24 hrs. The aim of the SSSD is to establish patient reported endpoints for the treatment of Sjogrens syndrome. Participants will complete the diary daily for 7 days prior to the scheduled dosing.
  measure: Pre-dose Ianalumab serum concentrations
  time frame: pre-dose (i.e., Ctrough) at Week 52 and Week 64
  description: To show comparability of ianalumab Ctrough between 2x 1 mL PFS (from the NEPTUNUS core studies: CVAY736A2301 and CVAY736A2302) and 1x 2 mL PFS for participants on continuous monthly treatment.
  measure: On-treatment Ianalumab serum concentrations
  time frame: During treatment (e.g., Ctrough) i.e. from Week 52 to Week 204 and follow-up i.e. 304, after last dose.
  description: To further assess the pharmacokinetics of ianalumab.
  measure: B-cell count measurement
  time frame: Week 52 to Week 304
  description: To assess impact of long-term treatment on B-cell depletion.
  arm group label: Ianalumab Monthly
  arm group type: Experimental
  description: ianalumab 300 mg s.c. monthly
  arm group label: Ianalumab 3 Monthly
  arm group type: Experimental
  description: ianalumab 300 mg s.c. every three months
  intervention type: Drug
  intervention name: Ianalumab (VAY736)
  description: VAY736 300 mg /2 mL, PFS, Solution for injection for subcutaneous use
  arm group label: Ianalumab 3 Monthly
  arm group label: Ianalumab Monthly
  intervention type: Other
  intervention name: Placebo
  description: Placebo 0 mg/2 mL, PFS, Solution for injection for subcutaneous Use
  arm group label: Ianalumab 3 Monthly
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  last name: Novartis Pharmaceuticals
  phone: 1-888-669-6682
  email: novartis.email@novartis.com
  last name: Novartis Pharmaceuticals
  phone: +41613241111
  responsible party type: Sponsor
  mesh term: Sjogren's Syndrome
  mesh term: Syndrome
  sharing ipd: Yes
  ipd description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
  This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com