Primary Sjogren SyndromePhase 2NCT02962895
Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
A Phase 2 study testing VAY736 in people with Primary Sjogren Syndrome, run by Novartis Pharmaceuticals at 56 sites in 19 countries.
Trial summary
The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjogren Syndrome
- What is being tested?
- VAY736
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 56 sitesin 19 countries
- Study dates
- 27 Jun 2017to 23 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilled revised American European Consensus Group criteria for pSS
- Seropositive at screening for anti-Ro/SSA antibodies
- Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic.
Who cannot join
- Secondary Sjogren's syndrome
- Use of other investigational drugs
- Active viral, bacterial or other infections
- Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
Trial locations and contacts
56 sites in 19 countries.
56 sites in 19 countries
United States9 sites
The John Hopkins Jerome L Greene Sjogren
Baltimore, Maryland, 21224
Tufts School of Dental Medicine
Boston, Massachusetts, 02111
Baylor College Of Medicine
Houston, Texas, 77030
Indiana Univ School of Dentistry
Indianapolis, Indiana, 46202
UPMC
Pittsburgh, Pennsylvania, 15213
Integral Rheumatology and Immunology Specialists IRIS
Plantation, Florida, 33324
AAIR Research Center
Rochester, New York, 14618
First Outpatient Research Unit
San Antonio, Texas, 78229
Advanced Rheumatology and Arthritis Wellness Center
Wexford, Pennsylvania, 15090
Argentina4 sites
Novartis Investigative Site
CABA, 1117
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, C1055AAF
Novartis Investigative Site
Córdoba, 5000
Novartis Investigative Site
Córdoba, X5016KEH
Germany4 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
München, 81377
Novartis Investigative Site
Würzburg, 97080
Japan4 sites
Novartis Investigative Site
Nagoya, Aichi-ken, 457 8510
Novartis Investigative Site
Sasebo, Nagasaki, 857-1165
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160 8582
Novartis Investigative Site
tabashi City, Tokyo, 173-8610
Portugal4 sites
Novartis Investigative Site
Almada, 2801 951
Novartis Investigative Site
Lisbon, 1050-034
Novartis Investigative Site
Lisbon, 1649 035
Novartis Investigative Site
Porto, 4099-001
Russia4 sites
Novartis Investigative Site
Moscow, 115522
Novartis Investigative Site
Orenburg, 460000
Novartis Investigative Site
Saint Petersburg, 195257
Novartis Investigative Site
Yekaterinburg, 620028
Taiwan4 sites
Novartis Investigative Site
Kaohsiung City, 81346
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taichung, 407219
Novartis Investigative Site
Taipei, 11490
Italy3 sites
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Udine, UD, 33100
Spain3 sites
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Novartis Investigative Site
Vigo, Pontevedra, 36200
United Kingdom3 sites
Novartis Investigative Site
Birmingham, B15 2TH
Novartis Investigative Site
Liverpool, L9 7AL
Novartis Investigative Site
Southend, SSO 0RY
Belgium2 sites
Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Leuven, 3000
Chile2 sites
Novartis Investigative Site
Santiago, 7500710
Novartis Investigative Site
Santiago, 8207257
France2 sites
Novartis Investigative Site
Brest, 29200
Novartis Investigative Site
Lille, 59037
Hungary2 sites
Novartis Investigative Site
Budapest, H-1097
Novartis Investigative Site
Szeged, 6720
Romania2 sites
Novartis Investigative Site
Brasov, 500283
Novartis Investigative Site
Cluj-Napoca, 400006
Netherlands1 site
Novartis Investigative Site
Rotterdam, South Holland, 3015 GD
About this study
Official title: Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)
The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters
Read the detailed description
This was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial that was divided into 4 study periods.
Period 1: A screening period of 4 weeks to assess patient eligibility. Patients could be re-screened only once, and no study-related re-screening procedure could be performed prior to written re-consent by the patient.
Period 2: A blinded treatment period of 24 weeks. At baseline, eligible patients were randomized to one of three ianalumab dose arms (VAY736 5 mg, 50 mg or 300 mg s.c.) or a placebo arm (placebo s.c.). Blinded study drug was administered every four weeks (q4w) for a 24-week period.
Except for Japan, randomization was stratified by baseline ESSDAI score (<10 or ≥10 based on weighted scores). Separate blocks of randomization numbers were generated for patients in Japan versus the other countries participating to ensure that Japanese patients were equally distributed across all treatment groups in the study.
The primary endpoint was assessed at the end of Period 2 (Week 24). Treatment assignment in Period 2 remained double-blinded until the end of Period 3.
Period 3: An extended blinded treatment period of 28 weeks. After Week 24 assessments, patients in the ianalumab 300 mg arm were re-randomized in a 1:1 ratio to either continue on ianalumab 300 mg s.c. q4w or switch to matching placebo up to Week 52. Patients who received placebo during Period 2 were switched to ianalumab 150 mg s.c q4w up to Week 52. Patients who received 5 mg and 50 mg s.c. in Period 2 proceeded directly to safety follow-up (Period 4). Treatment assignment in Period 3 remained double-blinded.
Period 4: A post-treatment safety follow-up period. Patients who prematurely discontinued the study treatment at any time point or completed the treatment as planned entered the safety follow-up period. The minimum required duration of follow-up in the study was 20 weeks from the last administration of the study treatment (mandatory follow-up). The maximum duration of the follow-up was 2 years from the last dose of the study treatment, and it was defined by the level of recovery of CD19+ B-cells: conditional follow up (with reduced visit frequency) until CD19+ B-cell levels return to at least 80% of baseline or 50 cells/µL, whichever occurred first. Patients who had not yet recovered their B-cell counts two years after last ianalumab dosing were discharged from the study and had undergone their End of Study (EoS) visit. Patients who were treated with another immunomodulatory or immunosuppressive treatment (e.g., azathioprine, cyclophosphamide, high dose glucocorticosteroids) after completion of the minimum 20-week safety follow-up period were excluded from further safety follow-up.
- Conditions
- Primary Sjogren Syndrome
- Being tested
- VAY736, Placebo
- Keywords
- Sjogren, VAY736, ianalumab, pSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAY736Biological
Also called Ianalumab
VAY736
PlaceboOther
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| VAY736 dose 1 - 5mg | Experimental | VAY736 low Receives: Biological: VAY736 |
| VAY736 dose 2 - 50mg | Experimental | VAY736 medium Receives: Biological: VAY736 |
| VAY736 dose 3 - 300 mg | Experimental | VAY736 high Receives: Biological: VAY736 |
| Placebo | Placebo comparator | Placebo control Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Change From Baseline in ESSDAI Score at Week 24
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score ranging 0-123. Higher scores on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
Measured: Baseline, Week 24
Secondary outcomes (14)
Least Squares Mean Change From Baseline in ESSDAI Score at Weeks 4, 8, 12, and 16
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score ranging 0-123. Higher scores on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Least Squares Mean Change From Baseline in ESSPRI Score at Week 24
The EULAR Sjörgen's Syndrome Patient Reported Index (ESSPRI) is an established disease outcome measure for Sjögren's syndrome that is calculated by averaging the scales for pain, fatigue and dryness. The total score is the mean score of the 3 scales and ranges between 0 and 10 with higher values indicating more severity of symptoms. A negative change from baseline is a favorable outcome.
Measured: Baseline, Week 24
Least Squares Mean Change From Baseline in ESSPRI Score at Weeks 4, 8, 12 and 16
The EULAR Sjörgen's Syndrome Patient Reported Index (ESSPRI) is an established disease outcome measure for Sjögren's syndrome that is calculated by averaging the scales for pain, fatigue and dryness. The total score is the mean score of the 3 scales and ranges between 0 and 10 with higher values indicating more severity of symptoms. A negative change from baseline is a favorable outcome.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score Over 24 Weeks
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F v4) is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the previous week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The global score ranges between 0 and 52, with higher scores indicating less fatigue.
Measured: Baseline, Week 24
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score at Weeks 4, 8, 12 and 16
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F v4) is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the previous week. The level of fatigue is measured on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The global score ranges between 0 and 52, with higher scores indicating less fatigue.
Measured: Baseline, Weeks 4, 8, 12 and 16
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) Over 24 Weeks
The SF36 includes 8 scale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) and two summary scores, the physical and mental component scores. The first four and last four scales comprise physical and mental component scores, respectively. The range of scores of the physical component (PCS) and mental component (MCS) is 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).
Measured: Baseline, Week 24
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
The SF36 includes 8 scale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) and two summary scores, the physical and mental component scores. The first four and last four scales comprise physical and mental component scores, respectively. The range of scores of the physical component (PCS) and mental component (MCS) is 0 (lowest or worst possible level of functioning) to 100 (highest or best possible level of functioning).
Measured: Baseline, Weeks 4, 8, 12 and 16
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) Over 24 Weeks
Physician global assessment of overall disease activity (PhGA) was performed using a 100 mm visual analogue scale (VAS) ranging from no disease activity (score 0) to maximal disease activity (score 100), after the question "Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today". A negative change from baseline is a favourable outcome.
Measured: Baseline, 24 weeks
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) at Weeks 4, 8, 12 and 16
Physician global assessment of overall disease activity (PhGA) was performed using a 100 mm visual analogue scale (VAS) ranging from no disease activity (score 0) to maximal disease activity (score 100), after the question "Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today". A negative change from baseline is a favourable outcome.
Measured: Baseline, Weeks 4, 8, 12 and 16
Patient's Global Assessment (PaGA) Score at Weeks 4, 8, 12, 16 and 24
The PaGA of disease activity was performed using a 100 mm Visual Analog Scale (VAS) ranging from 0 (no disease activity) to 100 (maximal disease activity), in response to the question "Considering all the ways Sjögren's syndrome affects you, please draw a line on the scale to indicate how well you are doing today". A negative change from baseline is a favourable outcome.
Measured: Weeks 4, 8, 12, 16 and 24
Least Squares Mean Change From Baseline in Salivary Flow Rate at Week 24
Change from baseline in salivary flow rate (unstimulated and stimulated) at 24 weeks as compared to placebo.
Unstimulated saliva is a mix of serous and mucous secretions coming primarily from the submandibular and minor salivary glands. The parotid gland produces the largest volume of stimulated saliva. Stimulated saliva accounts for 80-90% of daily salivary production.
Measured: Baseline, 24 weeks
Percent Change From Baseline in Whole Blood CD19+ B-cell Counts.
B-cell counts were measured before, during and after treatment with VAY736. After stopping VAY736 treatment they were used to monitor patients for time to recovery of adequate CD19+ B cell counts prior to discharge from the study. Change from baseline in B-cell counts before, during and after treatment with VAY736 as well as the time to recover to baseline like values (defined as at least 80% of baseline counts or >= 50 cells/μL) were analyzed by descriptive statistics.
Baseline was defined as the last assessment performed on or prior to the date of administration of the first dose of study treatment.
Measured: Baseline, Week 24, Week 28
Kaplan-Meier Analysis for Time to Recovery to Baseline Like Values for B-cell Counts
B-cell counts were measured before, during and after treatment with VAY736. After stopping VAY736 treatment they were used to monitor patients for time to recovery of adequate CD19+ B cell counts prior to discharge from the study. Change from baseline in B-cell counts before, during and after treatment with VAY736 as well as the time to recover to baseline like values (defined as at least 80% of baseline counts or >= 50 cells/μL) were analyzed by descriptive statistics.
Baseline was defined as the last assessment performed on or prior to the date of administration of the first dose of study treatment.
Measured: Up to two years from last dose patient received.
Peak Serum Concentration of VAY736
Pharmacokinetic Concentrations
This outcome only applies to patients who received at least one dose of VAY739 (so not applicable to placebo)
Measured: baseline to week 24, then week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start27 Jun 2017
- Primary completion30 Jun 2020
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Sjogren SyndromeStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial which planned to enroll approximately 180 patients with moderate to severe primary Sjögren's syndrome. The study was divided into 4 study periods: Period 1: 4-week Screening to assess patient eligibility. Period 2: 24-week Blinded treatment period. Period 3: An extended blinded treatment period of 28 weeks. After Week 24 assessments, patients in the ianalumab 300 mg arm were re-randomized in a 1:1 ratio to either continue on ianalumab 300 mg s.c. q4w or switch to matching placebo up to Week 52. Period 4: Post-treatment safety follow-up period. Patients who prematurely discontinued the study treatment at any time point or completed the treatment as planned entered the safety follow-up period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962895
- Sponsor's protocol ID
- CVAY736A2201
- Status last verified
- Jan 2025
- First submitted
- 3 Nov 2016
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
Publications
Dorner T, Bowman SJ, Fox R, Mariette X, Papas A, Grader-Beck T, Fisher BA, Barcelos F, De Vita S, Schulze-Koops H, Moots RJ, Junge G, Woznicki J, Sopala M, Avrameas A, Luo WL, Hueber W. Safety and Efficacy of Ianalumab in Patients With Sjogren's Disease: 52-Week Results From a Randomized, Placebo-Controlled, Phase 2b Dose-Ranging Study. Arthritis Rheumatol. 2025 May;77(5):560-570. doi: 10.1002/art.43059. Epub 2025 Jan 5.
PubMed 39557617Bowman SJ, Fox R, Dorner T, Mariette X, Papas A, Grader-Beck T, Fisher BA, Barcelos F, De Vita S, Schulze-Koops H, Moots RJ, Junge G, Woznicki JN, Sopala MA, Luo WL, Hueber W. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjogren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Lancet. 2022 Jan 8;399(10320):161-171. doi: 10.1016/S0140-6736(21)02251-0. Epub 2021 Nov 30.
PubMed 34861168
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)
- ClinicalTrials.gov ID
- NCT02962895
- Acronym / sponsor ID
- CVAY736A2201
- Conditions
- Primary Sjogren Syndrome
- Keywords
- Sjogren, VAY736, ianalumab, pSS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters
Detailed description
This was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial that was divided into 4 study periods.
Period 1: A screening period of 4 weeks to assess patient eligibility. Patients could be re-screened only once, and no study-related re-screening procedure could be performed prior to written re-consent by the patient.
Period 2: A blinded treatment period of 24 weeks. At baseline, eligible patients were randomized to one of three ianalumab dose arms (VAY736 5 mg, 50 mg or 300 mg s.c.) or a placebo arm (placebo s.c.). Blinded study drug was administered every four weeks (q4w) for a 24-week period.
Except for Japan, randomization was stratified by baseline ESSDAI score (<10 or ≥10 based on weighted scores). Separate blocks of randomization numbers were generated for patients in Japan versus the other countries participating to ensure that Japanese patients were equally distributed across all treatment groups in the study.
The primary endpoint was assessed at the end of Period 2 (Week 24). Treatment assignment in Period 2 remained double-blinded until the end of Period 3.
Period 3: An extended blinded treatment period of 28 weeks. After Week 24 assessments, patients in the ianalumab 300 mg arm were re-randomized in a 1:1 ratio to either continue on ianalumab 300 mg s.c. q4w or switch to matching placebo up to Week 52. Patients who received placebo during Period 2 were switched to ianalumab 150 mg s.c q4w up to Week 52. Patients who received 5 mg and 50 mg s.c. in Period 2 proceeded directly to safety follow-up (Period 4). Treatment assignment in Period 3 remained double-blinded.
Period 4: A post-treatment safety follow-up period. Patients who prematurely discontinued the study treatment at any time point or completed the treatment as planned entered the safety follow-up period. The minimum required duration of follow-up in the study was 20 weeks from the last administration of the study treatment (mandatory follow-up). The maximum duration of the follow-up was 2 years from the last dose of the study treatment, and it was defined by the level of recovery of CD19+ B-cells: conditional follow up (with reduced visit frequency) until CD19+ B-cell levels return to at least 80% of baseline or 50 cells/µL, whichever occurred first. Patients who had not yet recovered their B-cell counts two years after last ianalumab dosing were discharged from the study and had undergone their End of Study (EoS) visit. Patients who were treated with another immunomodulatory or immunosuppressive treatment (e.g., azathioprine, cyclophosphamide, high dose glucocorticosteroids) after completion of the minimum 20-week safety follow-up period were excluded from further safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial which planned to enroll approximately 180 patients with moderate to severe primary Sjögren's syndrome. The study was divided into 4 study periods: Period 1: 4-week Screening to assess patient eligibility. Period 2: 24-week Blinded treatment period. Period 3: An extended blinded treatment period of 28 weeks. After Week 24 assessments, patients in the ianalumab 300 mg arm were re-randomized in a 1:1 ratio to either continue on ianalumab 300 mg s.c. q4w or switch to matching placebo up to Week 52. Period 4: Post-treatment safety follow-up period. Patients who prematurely discontinued the study treatment at any time point or completed the treatment as planned entered the safety follow-up period.
| Arm | Type | Receives |
|---|---|---|
| VAY736 dose 1 - 5mg | Experimental | Biological: VAY736VAY736 low |
| VAY736 dose 2 - 50mg | Experimental | Biological: VAY736VAY736 medium |
| VAY736 dose 3 - 300 mg | Experimental | Biological: VAY736VAY736 high |
| Placebo | Placebo comparator | Other: PlaceboPlacebo control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fulfilled revised American European Consensus Group criteria for pSS
- Seropositive at screening for anti-Ro/SSA antibodies
- Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic.
Key exclusion criteria (4 listed)
- Secondary Sjogren's syndrome
- Use of other investigational drugs
- Active viral, bacterial or other infections
- Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAY736Also: IanalumabVAY736 | Biological | VAY736 dose 1 - 5mg, VAY736 dose 2 - 50mg, VAY736 dose 3 - 300 mg |
| PlaceboPlacebo control | Other | Placebo |
Primary outcome
Least Squares Mean Change From Baseline in ESSDAI Score at Week 24
Time frame: Baseline, Week 24
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score ranging 0-123. Higher scores on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
14 secondary outcomes
Least Squares Mean Change From Baseline in ESSDAI Score at Weeks 4, 8, 12, and 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Least Squares Mean Change From Baseline in ESSPRI Score at Week 24
Time frame: Baseline, Week 24
Least Squares Mean Change From Baseline in ESSPRI Score at Weeks 4, 8, 12 and 16
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score Over 24 Weeks
Time frame: Baseline, Week 24
Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score at Weeks 4, 8, 12 and 16
Time frame: Baseline, Weeks 4, 8, 12 and 16
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) Over 24 Weeks
Time frame: Baseline, Week 24
Least Squares Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component (PCS) and Mental Component (MCS) at Weeks 4, 8, 12 and 16
Time frame: Baseline, Weeks 4, 8, 12 and 16
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) Over 24 Weeks
Time frame: Baseline, 24 weeks
Least Squares Mean Change From Baseline in Physician's Global Assessment (PhGA) of Patient's Overall Disease Activity Using Patient Visual Analog Scale (VAS) at Weeks 4, 8, 12 and 16
Time frame: Baseline, Weeks 4, 8, 12 and 16
Patient's Global Assessment (PaGA) Score at Weeks 4, 8, 12, 16 and 24
Time frame: Weeks 4, 8, 12, 16 and 24
Least Squares Mean Change From Baseline in Salivary Flow Rate at Week 24
Time frame: Baseline, 24 weeks
Percent Change From Baseline in Whole Blood CD19+ B-cell Counts.
Time frame: Baseline, Week 24, Week 28
Kaplan-Meier Analysis for Time to Recovery to Baseline Like Values for B-cell Counts
Time frame: Up to two years from last dose patient received.
Peak Serum Concentration of VAY736
Time frame: baseline to week 24, then week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39557617Dorner T, Bowman SJ, Fox R, Mariette X, Papas A, Grader-Beck T, Fisher BA, Barcelos F, De Vita S, Schulze-Koops H, Moots RJ, Junge G, Woznicki J, Sopala M, Avrameas A, Luo WL, Hueber W. Safety and Efficacy of Ianalumab in Patients With Sjogren's Disease: 52-Week Results From a Randomized, Placebo-Controlled, Phase 2b Dose-Ranging Study. Arthritis Rheumatol. 2025 May;77(5):560-570. doi: 10.1002/art.43059. Epub 2025 Jan 5.
- Derived from this study: PubMed 34861168Bowman SJ, Fox R, Dorner T, Mariette X, Papas A, Grader-Beck T, Fisher BA, Barcelos F, De Vita S, Schulze-Koops H, Moots RJ, Junge G, Woznicki JN, Sopala MA, Luo WL, Hueber W. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjogren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Lancet. 2022 Jan 8;399(10320):161-171. doi: 10.1016/S0140-6736(21)02251-0. Epub 2021 Nov 30.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
56 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAY736 in people with Primary Sjogren Syndrome, run by Novartis Pharmaceuticals at 56 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Argentina, Germany, Japan, Portugal and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Least Squares Mean Change From Baseline in ESSDAI Score at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02962895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.