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 From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)Primary· Baseline and Week 12
The effect of CFZ533 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
Cohort 1 CFZ533
12.0
± 3.78
Cohort 1 Placebo
11.8
± 3.86
Cohort 2 CFZ533
10.6
± 4.44
Cohort 2 Placebo
11.0
± 5.16
Cohort 3 CFZ533 Arm 1
12.7
± 6.06
Cohort 3 CFZ533 Arm 2
10.4
± 5.87
Week 12
Group
Value
95% CI
Cohort 1 CFZ533
9.6
± 5.45
Cohort 1 Placebo
9.8
± 3.30
Cohort 2 CFZ533
4.2
± 4.25
Cohort 2 Placebo
9.7
± 9.05
Cohort 3 CFZ533 Arm 1
7.2
± 6.69
Cohort 3 CFZ533 Arm 2
2.8
± 2.48
Change from Baseline to Week 12
Group
Value
95% CI
Cohort 1 CFZ533
-2.4
± 2.77
Cohort 1 Placebo
-2.0
± 2.45
Cohort 2 CFZ533
-6.4
± 4.00
Cohort 2 Placebo
-1.3
± 8.06
Cohort 3 CFZ533 Arm 1
-5.5
± 5.49
Cohort 3 CFZ533 Arm 2
-7.6
± 7.14
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)Secondary· Baseline and 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.
Baseline
Group
Value
95% CI
Cohort 1 CFZ533
6.75
± 1.909
Cohort 1 Placebo
7.00
± 1.826
Cohort 2 CFZ533
6.71
± 1.678
Cohort 2 Placebo
7.18
± 1.486
Cohort 3 CFZ533 Arm 1
7.00
± 1.604
Cohort 3 CFZ533 Arm 2
6.00
± 2.344
Week 12
Group
Value
95% CI
Cohort 1 CFZ533
5.71
± 1.240
Cohort 1 Placebo
7.08
± 2.251
Cohort 2 CFZ533
5.03
± 2.413
Cohort 2 Placebo
6.24
± 2.039
Cohort 3 CFZ533 Arm 1
5.33
± 2.269
Cohort 3 CFZ533 Arm 2
4.83
± 2.552
Change from Baseline to Week 12
Group
Value
95% CI
Cohort 1 CFZ533
-1.04
± 1.201
Cohort 1 Placebo
0.08
± 0.631
Cohort 2 CFZ533
-1.68
± 1.954
Cohort 2 Placebo
-0.94
± 1.246
Cohort 3 CFZ533 Arm 1
-1.67
± 1.841
Cohort 3 CFZ533 Arm 2
-1.17
± 2.333
Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)Secondary· Baseline and 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
Cohort 1 CFZ533
57.9
± 15.72
Cohort 1 Placebo
57.8
± 17.19
Cohort 2 CFZ533
51.9
± 12.62
Cohort 2 Placebo
47.9
± 19.18
Cohort 3 CFZ533 Arm 1
50.4
± 12.39
Cohort 3 CFZ533 Arm 2
47.1
± 18.34
Week 12
Group
Value
95% CI
Cohort 1 CFZ533
40.5
± 16.42
Cohort 1 Placebo
55.5
± 12.01
Cohort 2 CFZ533
22.8
± 11.78
Cohort 2 Placebo
34.2
± 13.90
Cohort 3 CFZ533 Arm 1
25.4
± 16.65
Cohort 3 CFZ533 Arm 2
27.3
± 16.74
Change from Baseline to Week 12
Group
Value
95% CI
Cohort 1 CFZ533
-17.6
± 24.60
Cohort 1 Placebo
-2.3
± 10.90
Cohort 2 CFZ533
-28.7
± 16.02
Cohort 2 Placebo
-13.7
± 22.97
Cohort 3 CFZ533 Arm 1
-25.0
± 15.30
Cohort 3 CFZ533 Arm 2
-19.8
± 21.96
Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)Secondary· Baseline and 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
Cohort 1 CFZ533
47.13
± 32.406
Cohort 1 Placebo
73.00
± 12.623
Cohort 2 CFZ533
58.43
± 19.881
Cohort 2 Placebo
54.91
± 21.002
Cohort 3 CFZ533 Arm 1
63.69
± 25.799
Cohort 3 CFZ533 Arm 2
52.08
± 22.138
Week 12
Group
Value
95% CI
Cohort 1 CFZ533
49.06
± 24.519
Cohort 1 Placebo
75.50
± 24.393
Cohort 2 CFZ533
34.85
± 24.564
Cohort 2 Placebo
42.27
± 24.483
Cohort 3 CFZ533 Arm 1
38.46
± 26.965
Cohort 3 CFZ533 Arm 2
53.17
± 25.305
Change from Baseline to Week 12
Group
Value
95% CI
Cohort 1 CFZ533
1.94
± 26.023
Cohort 1 Placebo
2.50
± 17.861
Cohort 2 CFZ533
-23.05
± 26.920
Cohort 2 Placebo
-12.64
± 26.871
Cohort 3 CFZ533 Arm 1
-25.23
± 29.833
Cohort 3 CFZ533 Arm 2
1.08
± 23.283
Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component ScoreSecondary· Baseline and 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.
Baseline
Group
Value
95% CI
Cohort 1 CFZ533
42.218
± 6.9437
Cohort 1 Placebo
31.215
± 12.5562
Cohort 2 CFZ533
38.163
± 8.5905
Cohort 2 Placebo
38.819
± 5.9689
Week 12
Group
Value
95% CI
Cohort 1 CFZ533
40.374
± 9.2230
Cohort 1 Placebo
36.123
± 13.0002
Cohort 2 CFZ533
44.001
± 9.3943
Cohort 2 Placebo
40.298
± 8.9392
Change from Baseline to Week 12
Group
Value
95% CI
Cohort 1 CFZ533
-1.005
± 4.5380
Cohort 1 Placebo
4.908
± 4.2349
Cohort 2 CFZ533
5.546
± 7.1760
Cohort 2 Placebo
1.479
± 8.2497
Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component ScoreSecondary· Baseline and 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.
Baseline
Group
Value
95% CI
Cohort 1 CFZ533
46.838
± 7.8986
Cohort 1 Placebo
43.118
± 16.3701
Cohort 2 CFZ533
37.071
± 12.2914
Cohort 2 Placebo
39.512
± 15.4212
Week 12
Group
Value
95% CI
Cohort 1 CFZ533
48.076
± 12.5197
Cohort 1 Placebo
43.660
± 13.9997
Cohort 2 CFZ533
44.688
± 10.2469
Cohort 2 Placebo
43.785
± 13.2982
Change from Baseline to Week 12
Group
Value
95% CI
Cohort 1 CFZ533
0.373
± 6.3174
Cohort 1 Placebo
0.543
± 4.0309
Cohort 2 CFZ533
8.212
± 11.1378
Cohort 2 Placebo
4.273
± 10.7671
Change From Baseline in Multidimensional Fatigue Inventory (MFI)Secondary· Baseline and 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 possible range from 4-20. The reported total score has a range from 20-100. A reduction from baseline in MFI indicates improvement.
Baseline
Group
Value
95% CI
Cohort 1 CFZ533
54.1
± 16.23
Cohort 1 Placebo
78.0
± 17.80
Cohort 2 CFZ533
70.0
± 17.51
Cohort 2 Placebo
66.2
± 17.59
Week 12
Group
Value
95% CI
Cohort 1 CFZ533
53.5
± 13.96
Cohort 1 Placebo
69.8
± 17.75
Cohort 2 CFZ533
55.2
± 16.65
Cohort 2 Placebo
63.3
± 16.99
Change from Baseline to Week 12
Group
Value
95% CI
Cohort 1 CFZ533
-0.6
± 8.12
Cohort 1 Placebo
-8.3
± 8.18
Cohort 2 CFZ533
-14.5
± 18.09
Cohort 2 Placebo
-2.9
± 12.37
Adverse events — posted to ClinicalTrials.gov
Time frame: Cohort 1 and 2: 255 days (30 days post study completion) Cohort 3: 171 days (30 days post study completion).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1 CFZ533
Serious: 1/8 (13%)
Deaths: 0/8
Cohort 1 Placebo
Serious: 0/4 (0%)
Deaths: 0/4
Cohort 2 CFZ533
Serious: 1/21 (5%)
Deaths: 0/21
Cohort 2 Placebo
Serious: 0/11 (0%)
Deaths: 0/11
Cohort 3 CFZ533 Arm 1
Serious: 0/13 (0%)
Deaths: 0/13
Cohort 3 CFZ533 Arm 2
Serious: 1/12 (8%)
Deaths: 0/12
Serious adverse events (5 terms)
Reaction
System
Cohort 1 CFZ533
Cohort 1 Placebo
Cohort 2 CFZ533
Cohort 2 Placebo
Cohort 3 CFZ533 Arm 1
Cohort 3 CFZ533 Arm 2
Atrial fibrillation
Cardiac disorders
—
—
—
—
—
—
Conjunctivitis bacterial
Infections and infestations
—
—
—
—
—
—
Post procedural swelling
Injury, poisoning and procedural complications
—
—
—
—
—
—
Procedural pain
Injury, poisoning and procedural complications
—
—
—
—
—
—
Haemarthrosis
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Other adverse events (162 terms — click to expand)
This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 5 January 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/NCT02291029.