Phase 2
N=27
PD of VAY736 in Patients With Primary Sjögren's Syndrome
Primary Sjögren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02149420 ↗Enrolled (actual)
27
Serious AEs
12.5%
Results posted
Feb 2019
Primary outcome: Primary: Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) — 11.1; 14.5; 11.5; 12.5 units on a scale — p=0.678
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VAY736 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) |
11.1; 14.5; 11.5; 12.5; 10.2; 10.7 | 0.678 |
| PRIMARY Overall Incidence of Adverse Events |
8; 6; 11; 17; 2; 6 | — |
| SECONDARY Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) |
5.967; 6.049; 6.235; 5.926; 6.173; 4.568 | — |
| SECONDARY Change in Short Form (36) Health Survey (SF-36) |
46.886; 39.445; 46.015; 44.788; 45.493; 47.671 | — |
| SECONDARY Change in Multidimensional Fatigue Inventory (MFI) |
14.0; 17.0; 15.9; 12.8; 14.2; 12.4 | — |
| SECONDARY Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS) |
57.3; 66.2; 65.0; 59.8; 43.0; 48.5 | — |
| SECONDARY Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS) |
56.2; 67.2; 59.8; 55.2; 44.2; 40.8 | — |
| SECONDARY VAY736 Serum Concentration - AUCinf |
389; 1140; 971 | — |
| SECONDARY VAY736 Serum Concentration - AUClast |
385; 1140; 971 | — |
| SECONDARY VAY736 Serum Concentration - CL |
0.594; 0.584; 0.686 | — |
| SECONDARY VAY736 Serum Concentration - Cmax |
65.0; 213; 205 | — |
| SECONDARY VAY736 Serum Concentration - T1/2 |
8.43; 9.51; 11.0 | — |
| SECONDARY VAY736 Serum Concentration - Tmax |
2.03; 2.03; 2.10 | — |
| SECONDARY VAY736 Serum Concentration - Vz |
7.83; 8.68; 10.3 | — |
Summary
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
Eligibility Criteria
INCLUSION CRITERIA
- Fulfilled revised European US consensus criteria for pSS
- ESSDAI value ≥ 6
- Elevated serum titers at screening of ANA (≥ 1:160)
- Seropositive at screening for anti-SSA and/or anti-SSB antibodies
- Stimulated whole salivary flow rate at screening of > 0 mL/min
EXCLUSION CRITERIA
- Prior or previous use of (specific dosages and intervals prior to study start may apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig (abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause dry mouth.
Hydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to randomization is allowed
- Active or recent history of clinically significant infection
- Vaccination within 2 month prior to study
- History of primary or secondary immunodeficiency
Data sourced from ClinicalTrials.gov (NCT02149420). 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.