Study Summary
This trial is testing a potential new treatment for Sjögren's syndrome, and comparing it to a placebo and another existing treatment. It will assess how well it works and how safe it is.
Eligible Conditions
- Sjögren's Syndrome
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: Week 52 through study completion up to 2 years
24 weeks
Proportion of patients achieving ≥3 points reduction from baseline in ESSDAI score at Week 24
48 weeks
Change from baseline in Clinical Disease Activity Index (CDAI) score over 48 weeks
Change from baseline in Clinical European League Against Rheumatism Sjogrens Syndrome Disease Activity Index (ClinESSDAI) at Week 48
Change from baseline in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score at Week 48 as compared to placebo
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Change from baseline in Patient's Global Assessment (PaGA) of disease activity at Week 48
Change from baseline in Physician's Global Assessment (PhGA) of disease activity at Week 48
Change from baseline in Schirmer's test over 48 weeks
Change from baseline in stimulated whole salivary flow rate at Week 48
Proportion of patients achieving ESSDAI<5 at Week 48
Proportion of patients achieving improvement in the SSSD score at Week 48
Proportion of patients achieving meaningful improvement in the Sjogren's Syndrome Symptom Diary (SSSD) score at Week 48
Proportion of patients achieving ≥ 1 point or 15% reduction from baseline in ESSPRI at Week 48
Proportion of patients achieving ≥ 1 point or 15% reduction from baseline in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) at Week 48
Proportion of patients achieving ≥3 points reduction from baseline in ESSDAI score at Week 48
Baseline to Week 52
Incidence of Treatment-emergent AEs (TEAEs) /SAEs (Serious Adverse Event) from baseline to Week 52
Year 2
Incidence of Treatment Emergent Adverse Event (TEAEs)/Serious Adverse Events (SAEs) from Week 52 to end of study
Year 2
Ianalumab concentration in serum during the treatment and follow-up (up to the end of study)
Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay to end of study
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Open Label VAY736 10mg/kg
100%Nasopharyngitis
60%Infusion related reaction
20%Toothache
20%Inguinal hernia
20%Palpitations
20%Vitreous detachment
20%Conjunctivitis
20%Bronchitis
20%Headache
20%Otitis media
20%Sjogren's syndrome
20%Hypotension
20%Oropharyngeal pain
20%Dizziness
Trial Design
3 Treatment Groups
Arm A
1 of 3
Arm B
1 of 3
Arm C
1 of 3
Experimental Treatment
Non-Treatment Group
489 Total Participants · 3 Treatment Groups
Primary Treatment: Arm A · Has Placebo Group · Phase 3
Arm A
Biological
Experimental Group · 1 Intervention: VAY736 · Intervention Types: BiologicalArm B
Biological
Experimental Group · 1 Intervention: VAY736 · Intervention Types: BiologicalArm C
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VAY736
2014
Completed Phase 2
~290
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 52 through study completion up to 2 years
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,735 Previous Clinical Trials
3,543,554 Total Patients Enrolled
6 Trials studying Sjögren's Syndrome
899 Patients Enrolled for Sjögren's Syndrome
Eligibility Criteria
Age 18+ · All Participants · 12 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If you are taking hydroxychloroquine, methotrexate, or azathioprine for your condition, you can still participate in the study as long as you have been on a steady dose for at least 30 days before the study.
Who else is applying?
What state do they live in?
| Arkansas | 100.0% |
What site did they apply to?
| Novartis Investigative Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Why did patients apply to this trial?
- "I feel like my symptoms have gotten worse in the last couple of years. In the last four months alone I have started having migraines and weird electric tingling/ cramping feelings in my feet."
How many prior treatments have patients received?
| 0 | 100.0% |
Frequently Asked Questions
Has the FDA signed off on Arm A of this clinical trial?
"Arm A is safe according to our 3-point scale, as it is a Phase 3 trial with efficacy data as well as multiple rounds of safety data." - Anonymous Online Contributor
Unverified Answer