Adults 18 to 75, any sex, with Sjögren 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) Total Score at Week 24Primary· Baseline, Week 24
ESSDAI is a validated disease outcome measure for Sjögren's Syndrome. The instrument contains 12 organ-specific domains contributing to disease activity: constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological and biological. For each domain, features of disease activity were scored according to their severity. These scores were summed across the 12 domains in a weighted manner to provide the total score. ESSDAI total score ranges from 0 to 123 with higher values indicating more disease activ
Group
Value
95% CI
Remibrutinib 100 mg qd
-4.70
± 0.78
Remibrutinib 100 mg Bid
-3.70
± 0.80
Any Remibrutinib
-4.20
± 0.56
Placebo
-1.34
± 0.74
Change From Baseline in ESSDAI Total Score Over TimeSecondary· Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20
ESSDAI is a validated disease outcome measure for Sjögren's Syndrome. The instrument contains 12 organ-specific domains contributing to disease activity: constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological and biological. For each domain, features of disease activity were scored according to their severity. These scores were summed across the 12 domains in a weighted manner to provide the total score. ESSDAI total score ranges from 0 to 123 with higher values indicating more disease activ
Week 2
Group
Value
95% CI
Remibrutinib 100 mg qd
-1.68
± 0.52
Remibrutinib 100 mg Bid
-1.05
± 0.52
Any Remibrutinib
-1.37
± 0.37
Placebo
-0.37
± 0.55
Week 4
Group
Value
95% CI
Remibrutinib 100 mg qd
-2.57
± 0.60
Remibrutinib 100 mg Bid
-2.54
± 0.62
Any Remibrutinib
-2.55
± 0.43
Placebo
-0.79
± 0.61
Week 8
Group
Value
95% CI
Remibrutinib 100 mg qd
-2.74
± 0.72
Remibrutinib 100 mg Bid
-2.93
± 0.71
Any Remibrutinib
-2.83
± 0.51
Placebo
-2.36
± 0.69
Week 12
Group
Value
95% CI
Remibrutinib 100 mg qd
-3.66
± 0.74
Remibrutinib 100 mg Bid
-2.56
± 0.75
Any Remibrutinib
-3.11
± 0.53
Placebo
-1.92
± 0.73
Week 16
Group
Value
95% CI
Remibrutinib 100 mg qd
-4.02
± 0.71
Remibrutinib 100 mg Bid
-2.57
± 0.74
Any Remibrutinib
-3.29
± 0.51
Placebo
-2.16
± 0.69
Week 20
Group
Value
95% CI
Remibrutinib 100 mg qd
-4.40
± 0.73
Remibrutinib 100 mg Bid
-3.26
± 0.75
Any Remibrutinib
-3.83
± 0.52
Placebo
-1.84
± 0.69
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Total Score Over TimeSecondary· Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
ESSPRI is an established disease outcome measure for Sjögren's Syndrome. It consists of three domains of dryness, pain, and fatigue. The patient can assess the severity of symptoms they experience on a single 0-10 numerical scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain +fatigue) /3. ESSPRI total score ranges from 0 to 10 with higher values indicating more disease symptoms. A negative change from baseline indicates improvement.
The baseline value is defined as the last assessment performed prior to administration o
Week 2
Group
Value
95% CI
Remibrutinib 100 mg qd
-0.44
± 0.26
Remibrutinib 100 mg Bid
0.18
± 0.26
Any Remibrutinib
-0.13
± 0.18
Placebo
-0.09
± 0.27
Week 4
Group
Value
95% CI
Remibrutinib 100 mg qd
-0.72
± 0.30
Remibrutinib 100 mg Bid
-0.14
± 0.30
Any Remibrutinib
-0.43
± 0.21
Placebo
-0.35
± 0.30
Week 8
Group
Value
95% CI
Remibrutinib 100 mg qd
-0.83
± 0.31
Remibrutinib 100 mg Bid
-0.38
± 0.31
Any Remibrutinib
-0.60
± 0.22
Placebo
-0.57
± 0.29
Week 12
Group
Value
95% CI
Remibrutinib 100 mg qd
-0.88
± 0.31
Remibrutinib 100 mg Bid
-0.32
± 0.31
Any Remibrutinib
-0.60
± 0.22
Placebo
-0.66
± 0.29
Week 16
Group
Value
95% CI
Remibrutinib 100 mg qd
-0.77
± 0.36
Remibrutinib 100 mg Bid
-0.39
± 0.37
Any Remibrutinib
-0.58
± 0.26
Placebo
-0.71
± 0.34
Week 20
Group
Value
95% CI
Remibrutinib 100 mg qd
-0.92
± 0.38
Remibrutinib 100 mg Bid
-0.74
± 0.39
Any Remibrutinib
-0.83
± 0.27
Placebo
-0.92
± 0.36
Week 24
Group
Value
95% CI
Remibrutinib 100 mg qd
-1.17
± 0.34
Remibrutinib 100 mg Bid
-0.76
± 0.35
Any Remibrutinib
-0.96
± 0.24
Placebo
-1.13
± 0.31
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Total Score Over TimeSecondary· Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
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 past week. The level of fatigue was measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). FACIT-F total score ranges from 0 to 52 with higher values indicating higher quality of life (less fatigue). A positive change from baseline is a favorable outcome.
The baseline value is defined as the last assessment performed prior to administration of the first dose of study treatment.
A mixed
Week 2
Group
Value
95% CI
Remibrutinib 100 mg qd
1.80
± 1.32
Remibrutinib 100 mg Bid
-0.51
± 1.35
Any Remibrutinib
0.64
± 0.95
Placebo
3.37
± 1.43
Week 4
Group
Value
95% CI
Remibrutinib 100 mg qd
4.83
± 1.50
Remibrutinib 100 mg Bid
3.97
± 1.57
Any Remibrutinib
4.40
± 1.09
Placebo
3.51
± 1.58
Week 8
Group
Value
95% CI
Remibrutinib 100 mg qd
4.00
± 1.64
Remibrutinib 100 mg Bid
3.79
± 1.66
Any Remibrutinib
3.90
± 1.17
Placebo
5.26
± 1.60
Week 12
Group
Value
95% CI
Remibrutinib 100 mg qd
4.88
± 1.80
Remibrutinib 100 mg Bid
4.25
± 1.86
Any Remibrutinib
4.56
± 1.30
Placebo
7.30
± 1.77
Week 16
Group
Value
95% CI
Remibrutinib 100 mg qd
4.40
± 1.97
Remibrutinib 100 mg Bid
3.29
± 2.08
Any Remibrutinib
3.84
± 1.44
Placebo
7.73
± 1.98
Week 20
Group
Value
95% CI
Remibrutinib 100 mg qd
10.01
± 2.20
Remibrutinib 100 mg Bid
4.32
± 2.30
Any Remibrutinib
7.16
± 1.60
Placebo
5.77
± 2.17
Week 24
Group
Value
95% CI
Remibrutinib 100 mg qd
8.17
± 2.45
Remibrutinib 100 mg Bid
4.64
± 2.55
Any Remibrutinib
6.40
± 1.77
Placebo
7.45
± 2.32
Change From Baseline in EuroQual 5 Dimensions (EQ-5D) VAS Score Over TimeSecondary· Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
EQ-5D is a standardized instrument that measures the health-related quality of life. The EQ-5D consists of a descriptive system and a visual analog scale (VAS).The EQ-5D VAS records the patient's self-rated health on a vertical visual analogue scale with 0 representing 'Worst imaginable Health State' and 100 'Best imaginable Health State'. A positive change from baseline is a favorable outcome.
The baseline value is defined as the last assessment performed prior to administration of the first dose of study treatment.
A mixed effect model for repeated measurements (MMRM) was fitted to the cha
Week 2
Group
Value
95% CI
Remibrutinib 100 mg qd
-3.05
± 3.11
Remibrutinib 100 mg Bid
-2.86
± 3.16
Any Remibrutinib
-2.95
± 2.22
Placebo
-3.02
± 3.28
Week 4
Group
Value
95% CI
Remibrutinib 100 mg qd
-1.74
± 2.71
Remibrutinib 100 mg Bid
-0.03
± 2.86
Any Remibrutinib
-0.88
± 1.97
Placebo
2.99
± 2.87
Week 8
Group
Value
95% CI
Remibrutinib 100 mg qd
1.46
± 3.20
Remibrutinib 100 mg Bid
1.76
± 3.20
Any Remibrutinib
1.61
± 2.26
Placebo
3.44
± 3.04
Week 12
Group
Value
95% CI
Remibrutinib 100 mg qd
-2.36
± 2.71
Remibrutinib 100 mg Bid
1.58
± 2.82
Any Remibrutinib
-0.39
± 1.95
Placebo
4.00
± 2.64
Week 16
Group
Value
95% CI
Remibrutinib 100 mg qd
-0.44
± 3.27
Remibrutinib 100 mg Bid
4.27
± 3.54
Any Remibrutinib
1.92
± 2.41
Placebo
1.79
± 3.28
Week 20
Group
Value
95% CI
Remibrutinib 100 mg qd
-0.91
± 3.15
Remibrutinib 100 mg Bid
5.37
± 3.33
Any Remibrutinib
2.23
± 2.29
Placebo
5.29
± 3.01
Week 24
Group
Value
95% CI
Remibrutinib 100 mg qd
1.81
± 3.47
Remibrutinib 100 mg Bid
5.73
± 3.65
Any Remibrutinib
3.77
± 2.52
Placebo
2.07
± 3.22
Change From Baseline in Physician Global Assessment Scale (PhGA) Score Over TimeSecondary· Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
The physician's global assessment scale was used for the Investigator to rate the disease activity of their patient using 100 mm visual analog scale (VAS) ranging from "no disease activity" (0) to "maximal disease activity" (100). A negative change from baseline indicates improvement.
The baseline value is defined as the last assessment performed prior to administration of the first dose of study treatment.
A mixed effect model for repeated measurements (MMRM) was fitted to the changes from baseline in PhGA score for all post-baseline time points up to Week 24. Values estimated from the mode
Week 2
Group
Value
95% CI
Remibrutinib 100 mg qd
-4.21
± 2.90
Remibrutinib 100 mg Bid
-4.02
± 2.85
Any Remibrutinib
-4.12
± 2.04
Placebo
-4.82
± 3.10
Week 4
Group
Value
95% CI
Remibrutinib 100 mg qd
-9.58
± 2.89
Remibrutinib 100 mg Bid
-8.93
± 2.96
Any Remibrutinib
-9.26
± 2.08
Placebo
-7.28
± 2.95
Week 8
Group
Value
95% CI
Remibrutinib 100 mg qd
-13.68
± 3.39
Remibrutinib 100 mg Bid
-13.78
± 3.28
Any Remibrutinib
-13.73
± 2.37
Placebo
-13.23
± 3.16
Week 12
Group
Value
95% CI
Remibrutinib 100 mg qd
-13.85
± 3.63
Remibrutinib 100 mg Bid
-9.45
± 3.68
Any Remibrutinib
-11.65
± 2.60
Placebo
-17.67
± 3.52
Week 16
Group
Value
95% CI
Remibrutinib 100 mg qd
-19.37
± 3.61
Remibrutinib 100 mg Bid
-7.25
± 3.74
Any Remibrutinib
-13.31
± 2.61
Placebo
-15.90
± 3.51
Week 20
Group
Value
95% CI
Remibrutinib 100 mg qd
-23.56
± 3.43
Remibrutinib 100 mg Bid
-17.31
± 3.48
Any Remibrutinib
-20.43
± 2.45
Placebo
-17.57
± 3.20
Week 24
Group
Value
95% CI
Remibrutinib 100 mg qd
-21.25
± 3.88
Remibrutinib 100 mg Bid
-13.15
± 3.95
Any Remibrutinib
-17.20
± 2.78
Placebo
-20.15
± 3.54
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEsSecondary· From first dose of study treatment up 30 days after last dose (Week 29)
Number of participants with TEAEs and serious TEAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as TEAEs. TEAEs are defined as adverse events that started after the first dose of study medications or adverse events present prior to start of double-blind treatment but increased in severity.
The number of participants in each category is reported in the table.
TEAE
Group
Value
95% CI
Remibrutinib 100 mg Bid
22
Remibrutinib 100 mg qd
21
Placebo
20
Study drug-related TEAE
Group
Value
95% CI
Remibrutinib 100 mg Bid
10
Remibrutinib 100 mg qd
8
Placebo
9
Serious TEAE
Group
Value
95% CI
Remibrutinib 100 mg Bid
1
Remibrutinib 100 mg qd
1
Placebo
1
Maximum Observed Blood Concentration (Cmax) of Remibrutinib at Week 4Secondary· pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 4
Remibrutinib was determined in whole blood by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1.0 ng/mL. Pharmacokinetic (PK) parameters were calculated based on remibrutinib blood concentrations by using the actual recorded sampling times and non-compartmental methods with Phoenix WinNonlin (version 8 or higher). Concentrations below the LLOQ were treated as zero. Cmax is defined as the maximum (peak) observed blood concentration following a dose.
Group
Value
95% CI
Remibrutinib 100 mg Bid
183
± 82.5
Remibrutinib 100 mg qd
225
± 154
Maximum Observed Blood Concentration (Cmax) of Remibrutinib at Week 24Secondary· pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 24
Remibrutinib was determined in whole blood by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1.0 ng/mL. Pharmacokinetic (PK) parameters were calculated based on remibrutinib blood concentrations by using the actual recorded sampling times and non-compartmental methods with Phoenix WinNonlin (version 8 or higher). Concentrations below the LLOQ were treated as zero. Cmax is defined as the maximum (peak) observed blood concentration following a dose.
Group
Value
95% CI
Remibrutinib 100 mg Bid
224
± 202
Remibrutinib 100 mg qd
169
± 77.9
Time to Reach Maximum Observed Blood Concentration (Tmax) of Remibrutinib at Week 4Secondary· pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 4
Remibrutinib was determined in whole blood by a validated LC-MS/MS method with a LLOQ of 1.0 ng/mL. Pharmacokinetic (PK) parameters were calculated based on remibrutinib blood concentrations by using the actual recorded sampling times and non-compartmental methods with Phoenix WinNonlin (version 8 or higher). Concentrations below the LLOQ were treated as zero. Tmax is defined as the time to reach maximum (peak) blood concentration following a dose.
Group
Value
95% CI
Remibrutinib 100 mg Bid
1.00
0.500 – 3.00
Remibrutinib 100 mg qd
1.00
0.500 – 4.00
Time to Reach Maximum Observed Blood Concentration (Tmax) of Remibrutinib at Week 24Secondary· pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 24
Remibrutinib was determined in whole blood by a validated LC-MS/MS method with a LLOQ of 1.0 ng/mL. Pharmacokinetic (PK) parameters were calculated based on remibrutinib blood concentrations by using the actual recorded sampling times and non-compartmental methods with Phoenix WinNonlin (version 8 or higher). Concentrations below the LLOQ were treated as zero. Tmax is defined as the time to reach maximum (peak) blood concentration following a dose.
Group
Value
95% CI
Remibrutinib 100 mg Bid
1.00
0.500 – 3.00
Remibrutinib 100 mg qd
1.00
0.500 – 3.08
Area Under the Blood Concentration-time Curve Within a Dosing Interval (Tau) at Steady-state (AUCtau) of Remibrutinib at Week 4Secondary· pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 4
Remibrutinib was determined in whole blood by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1.0 ng/mL. Pharmacokinetic (PK) parameters were calculated based on remibrutinib blood concentrations by using the actual recorded sampling times and non-compartmental methods with Phoenix WinNonlin (version 8 or higher). Concentrations below the LLOQ were treated as zero. AUCtau is defined as the area under the blood concentration-time curve calculated/extrapolated to the end of a dosing interval (tau) at steady-state. Tau wa
Group
Value
95% CI
Remibrutinib 100 mg Bid
569
± 311
Remibrutinib 100 mg qd
1020
± 700
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study treatment up 30 days after last dose (Week 29).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome. LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07456891 — Remibrutinib Open Label Roll-over Post-trial Access Protocol
· Phase 3
· not yet recruiting
NCT06868212 — A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneou
· Phase 3
· recruiting
NCT06865651 — Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chron
· Phase 2
· recruiting
NCT05976243 — A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Ina
· Phase 3
· active not recruiting
NCT06042478 — Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizuma
· Phase 3
· active not recruiting
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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: 30 January 2023
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/NCT04035668.