Arm A for Sjögren's Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Sjögren's Syndrome+2 More
VAY736 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether ianalumab is an effective and safe treatment for patients with active Sjögren's syndrome.

Eligible Conditions
  • Sjögren's Syndrome

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

1 Primary · 8 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
Disease
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 meaningful improvement in 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
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 end of study)
Incidence of anti-ianalumab antibodies in serum Anti Drug Antibody (ADA) assay) up to end of study

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

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
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02149420) in the Open Label VAY736 10mg/kg ARM group. Side effects include: Nasopharyngitis with 100%, Infusion related reaction with 60%, Toothache with 20%, Inguinal hernia with 20%, Palpitations with 20%.

Trial Design

2 Treatment Groups

Arm A
1 of 2
Arm B
1 of 2

Experimental Treatment

Non-Treatment Group

268 Total Participants · 2 Treatment Groups

Primary Treatment: Arm A · Has Placebo Group · Phase 3

Arm A
Biological
Experimental Group · 1 Intervention: VAY736 · Intervention Types: Biological
Arm B
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VAY736
2014
Completed Phase 2
~320

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
2,698 Previous Clinical Trials
3,523,956 Total Patients Enrolled
6 Trials studying Sjögren's Syndrome
1,133 Patients Enrolled for Sjögren's Syndrome

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a sSF rate of ≥ 0.05 mL/min at screening.
You are able to communicate well with the Investigator, understand and agree to comply with the requirements of the study.
You have a clinical diagnosis of Sjögren's syndrome.
You have a diagnosis of Sjögren's syndrome of at least 7.5 years at screening.
Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.