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Monoclonal Antibodies
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome (SS Trial)
Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial tests VIB4920, a new drug for adults with Sjögren's Syndrome. It aims to help by preventing the immune system from attacking moisture-producing glands. The study includes patients with different levels of disease activity and symptoms.
Eligible Conditions
- Sjögren's Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 2 trial • 25 Patients • NCT0404654922%
COVID-19
17%
Anaemia
17%
Leukopenia
17%
BK virus infection
17%
Hypophosphataemia
13%
Arthralgia
13%
Headache
9%
Neutropenia
9%
Urinary tract infection
9%
Procedural pain
9%
Post procedural urine leak
9%
Hypokalaemia
9%
Metabolic acidosis
9%
Pain in extremity
9%
Insomnia
4%
Clostridium difficile infection
4%
Urosepsis
4%
Ileus
4%
Cholecystitis acute
4%
Kidney transplant rejection
4%
Bacteraemia
4%
Diabetic foot infection
4%
Cytomegalovirus test positive
4%
Hypervolaemia
4%
Depression suicidal
4%
Subcapsular renal haematoma
4%
Ureteric stenosis
4%
Arteriovenous fistula site complication
4%
Blood creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept+VIB4920
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: VIB4920 Dose 1 in Population 2Experimental Treatment2 Interventions
Participants in population 2 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II.
Group II: VIB4920 Dose 1 in Population 1Experimental Treatment2 Interventions
Participants in population 1 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II.
Group III: Placebo in Population 1Placebo Group2 Interventions
Participants in population 1 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II.
Group IV: Placebo in Population 2Placebo Group2 Interventions
Participants in population 2 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIB4920
2019
Completed Phase 2
~350
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,442 Previous Clinical Trials
1,397,561 Total Patients Enrolled
Viela BioLead Sponsor
12 Previous Clinical Trials
921 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
763 Total Patients Enrolled
MDStudy DirectorAmgen
980 Previous Clinical Trials
941,317 Total Patients Enrolled