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Monoclonal Antibodies

VIB4920 for 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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 trial • 25 Patients • NCT04046549
22%
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
1,431 Previous Clinical Trials
1,384,982 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
~30 spots leftby Nov 2025
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