Adults 18 to 75, any sex, with Primary Sjögren's Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)Primary· Baseline, week 12
The effect of VAY736 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The 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 (range 0-123). A reduction from baseline indicates improvement in patients.
Baseline
Group
Value
95% CI
Placebo
11.1
± 4.08
VAY736 3 mg/kg
14.5
± 9.44
VAY736 10 mg/kg
11.5
± 4.38
VAY736 Combined
12.5
± 6.38
Week 12
Group
Value
95% CI
Placebo
10.2
± 5.29
VAY736 3 mg/kg
10.7
± 7.69
VAY736 10 mg/kg
10.0
± 5.36
VAY736 Combined
10.2
± 6.01
Change from Baseline to Week 12
Group
Value
95% CI
Placebo
-0.9
± 2.98
VAY736 3 mg/kg
-3.8
± 8.66
VAY736 10 mg/kg
-1.5
± 3.00
VAY736 Combined
-2.3
± 5.40
Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)Secondary· Baseline, week 12
The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms. During the study all individual scores were reported as 1 to 10 instead. A linear transformation was reported to map the scores to the range of 0-10.
Baseline
Group
Value
95% CI
Placebo
5.967
± 2.2179
VAY736 3 mg/kg
6.049
± 1.2759
VAY736 10 mg/kg
6.235
± 1.5379
Week 12
Group
Value
95% CI
Placebo
5.926
± 1.5822
VAY736 3 mg/kg
6.173
± 1.4753
VAY736 10 mg/kg
4.568
± 2.5966
Change from Baseline to Week 12
Group
Value
95% CI
Placebo
-0.041
± 1.7805
VAY736 3 mg/kg
0.123
± 1.0120
VAY736 10 mg/kg
-1.667
± 1.8918
Change in Short Form (36) Health Survey (SF-36)Secondary· Baseline, week 12
The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.
Physical component score: Baseline
Group
Value
95% CI
Placebo
46.886
± 6.3905
VAY736 3 mg/kg
39.445
± 4.2857
VAY736 10 mg/kg
46.015
± 9.3533
Physical component score: Week 12
Group
Value
95% CI
Placebo
44.788
± 8.3513
VAY736 3 mg/kg
45.493
± 7.3060
VAY736 10 mg/kg
47.671
± 9.2804
Physical component score: Change from Baseline
Group
Value
95% CI
Placebo
-2.098
± 7.9084
VAY736 3 mg/kg
6.048
± 4.7189
VAY736 10 mg/kg
1.656
± 5.4113
Mental component score: Baseline
Group
Value
95% CI
Placebo
36.913
± 15.2776
VAY736 3 mg/kg
37.517
± 6.8994
VAY736 10 mg/kg
43.628
± 11.3667
Mental component score: Week 12
Group
Value
95% CI
Placebo
41.012
± 13.2991
VAY736 3 mg/kg
40.170
± 11.9815
VAY736 10 mg/kg
46.700
± 11.3182
Mental component score: Change from Baseline
Group
Value
95% CI
Placebo
4.099
± 5.3361
VAY736 3 mg/kg
2.653
± 17.1261
VAY736 10 mg/kg
3.073
± 11.5823
Change in Multidimensional Fatigue Inventory (MFI)Secondary· Baseline, week 12
The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a posible range from 4-20. A reduction from baseline in MFI indicates improvement.
General Fatigue: Baseline
Group
Value
95% CI
Placebo
14.0
± 4.72
VAY736 3 mg/kg
17.0
± 2.37
VAY736 10 mg/kg
15.9
± 3.34
General Fatigue: Week 12
Group
Value
95% CI
Placebo
12.8
± 4.84
VAY736 3 mg/kg
14.2
± 6.40
VAY736 10 mg/kg
12.4
± 3.99
General Fatigue: Change from Baseline
Group
Value
95% CI
Placebo
-1.2
± 1.64
VAY736 3 mg/kg
-2.8
± 5.04
VAY736 10 mg/kg
-3.5
± 4.12
Physical Fatigue: Baseline
Group
Value
95% CI
Placebo
12.9
± 4.14
VAY736 3 mg/kg
15.7
± 2.34
VAY736 10 mg/kg
14.2
± 3.41
Physical Fatigue: Week 12
Group
Value
95% CI
Placebo
12.2
± 3.99
VAY736 3 mg/kg
11.2
± 5.15
VAY736 10 mg/kg
10.4
± 4.66
Physical Fatigue: Change from Baseline
Group
Value
95% CI
Placebo
-0.7
± 1.32
VAY736 3 mg/kg
-4.5
± 6.57
VAY736 10 mg/kg
-3.8
± 4.77
Mental Fatigue: Baseline
Group
Value
95% CI
Placebo
11.9
± 4.78
VAY736 3 mg/kg
14.3
± 3.78
VAY736 10 mg/kg
13.0
± 3.28
Mental Fatigue: Week 12
Group
Value
95% CI
Placebo
11.7
± 4.12
VAY736 3 mg/kg
11.3
± 4.18
VAY736 10 mg/kg
9.8
± 5.17
Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)Secondary· Baseline, week 12
The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
Baseline
Group
Value
95% CI
Placebo
57.3
± 17.73
VAY736 3 mg/kg
66.2
± 17.53
VAY736 10 mg/kg
65.0
± 11.74
Week 12
Group
Value
95% CI
Placebo
59.8
± 23.35
VAY736 3 mg/kg
43.0
± 23.82
VAY736 10 mg/kg
48.5
± 17.33
Change from Baseline to Week 12
Group
Value
95% CI
Placebo
2.4
± 12.21
VAY736 3 mg/kg
-23.2
± 31.10
VAY736 10 mg/kg
-16.5
± 18.96
Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)Secondary· Baseline, week 12
The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
Baseline
Group
Value
95% CI
Placebo
56.2
± 24.86
VAY736 3 mg/kg
67.2
± 13.69
VAY736 10 mg/kg
59.8
± 24.30
Week 12
Group
Value
95% CI
Placebo
55.2
± 21.57
VAY736 3 mg/kg
44.2
± 22.75
VAY736 10 mg/kg
40.8
± 20.49
Change from Baseline to Week 12
Group
Value
95% CI
Placebo
-1.0
± 17.71
VAY736 3 mg/kg
-23.0
± 25.73
VAY736 10 mg/kg
-19.0
± 21.08
VAY736 Serum Concentration - AUCinfSecondary· 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.
The area under the serum concentration-time curve from time zero to infinity \[mass × time / volume\]. The concentration of VAY736 was measured in the serum.
Group
Value
95% CI
VAY736 3 mg/kg
389
186 – 457
VAY736 10 mg/kg
1140
515 – 1610
Open Label VAY736
971
849 – 1340
VAY736 Serum Concentration - AUClastSecondary· 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.
The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration \[mass × time / volume\]. The concentration of VAY736 was measured in the serum.
Group
Value
95% CI
VAY736 3 mg/kg
385
184 – 457
VAY736 10 mg/kg
1140
514 – 1610
Open Label VAY736
971
848 – 1340
VAY736 Serum Concentration - CLSecondary· 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.
The systemic (or total body) clearance from serum following intravenous administration \[volume / time\]. The concentration of VAY736 was measured in the serum.
Group
Value
95% CI
VAY736 3 mg/kg
0.594
0.427 – 0.844
VAY736 10 mg/kg
0.584
0.550 – 1.30
Open Label VAY736
0.686
0.427 – 0.750
VAY736 Serum Concentration - CmaxSecondary· 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.
The observed maximum serum concentration following drug administration \[mass / volume\]. The concentration of VAY736 was measured in the serum.
Group
Value
95% CI
VAY736 3 mg/kg
65.0
45.4 – 76.5
VAY736 10 mg/kg
213
150 – 283
Open Label VAY736
205
174 – 217
VAY736 Serum Concentration - T1/2Secondary· 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.
Apparent terminal half-life, determined as the ln2/lambda\_z or 0.693/lambda\_z. The concentration of VAY736 was measured in the serum.
Group
Value
95% CI
VAY736 3 mg/kg
8.43
6.99 – 13.8
VAY736 10 mg/kg
9.51
5.38 – 15.2
Open Label VAY736
11.0
4.94 – 17.4
VAY736 Serum Concentration - TmaxSecondary· 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.
The time to reach the maximum concentration after drug administration \[time\]. The concentration of VAY736 was measured in the serum.
Group
Value
95% CI
VAY736 3 mg/kg
2.03
2.00 – 2.20
VAY736 10 mg/kg
2.03
2.00 – 2.30
Open Label VAY736
2.10
2.02 – 2.17
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study was designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05349214 — Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
· Phase 3
· active not recruiting
NCT05350072 — Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
· Phase 3
· active not recruiting
NCT04903197 — Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lympho
· Phase 1
· terminated
NCT03827798 — Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 2
· active not recruiting
NCT03656562 — Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 4 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02149420.