Phase 2 N=190 Randomized Triple-blind Treatment

Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

Primary Sjogren Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02962895 ↗

Enrolled (actual)

190

Serious AEs

8.8%

Results posted

Oct 2024

Primary outcome: Primary: Least Squares Mean Change From Baseline in ESSDAI Score at Week 24 — -6.39; -5.64; -6.93; -8.30 Scores on a scale — p=0.5161

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: VAY736 (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Least Squares Mean Change From Baseline in ESSDAI Score at Week 24	-6.39; -5.64; -6.93; -8.30	0.5161
SECONDARY Least Squares Mean Change From Baseline in ESSDAI Score at Weeks 4, 8, 12, and 16	-3.73; -2.28; -3.37; -4.53; -4.13; -4.65	—
SECONDARY Least Squares Mean Change From Baseline in ESSPRI Score at Week 24	-1.71; -1.39; -1.70; -1.77	0.4457
SECONDARY Least Squares Mean Change From Baseline in ESSPRI Score at Weeks 4, 8, 12 and 16	-0.54; -0.67; -0.80; -0.88; -0.94; -0.84	—
SECONDARY Least Squares Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Score Over 24 Weeks	9.05; 7.12; 6.48; 9.36	0.3424
SECONDARY 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	3.78; 6.32; 3.12; 3.39; 5.49; 6.36	—
SECONDARY 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	4.63; 3.61; 5.31; 5.63; 3.66; 4.79	0.5768
SECONDARY 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	0.49; 1.89; 2.46; 2.18; 2.65; 3.80	—
SECONDARY 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	-23.64; -27.81; -28.13; -31.99	0.2671
SECONDARY 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	-12.49; -10.50; -12.38; -18.67; -18.54; -16.53	—
SECONDARY Patient's Global Assessment (PaGA) Score at Weeks 4, 8, 12, 16 and 24	-9.42; -10.02; -5.96; -8.96; -9.74; -11.48	0.6457
SECONDARY Least Squares Mean Change From Baseline in Salivary Flow Rate at Week 24	0.05; 0.16; 0.18; 0.25; 0.00; 0.01	0.2710
SECONDARY Percent Change From Baseline in Whole Blood CD19+ B-cell Counts.	-88.00; -99.07; 3.29; -103.0; -94.20; -97.06	—
SECONDARY Kaplan-Meier Analysis for Time to Recovery to Baseline Like Values for B-cell Counts	3.8; 4.8; 6.8; 8.4; 6.5	—
SECONDARY Peak Serum Concentration of VAY736	0.0747; 0.475; 1.46; 2.15; 1.94	—

Summary

The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02962895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.