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Monoclonal Antibodies

VIB4920 for Sjögren's Syndrome (SS Trial)

Phase 2
Waitlist Available
Research Sponsored by Viela Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an ESSDAI score of >= 5 at screening; (not including the peripheral nervous system, central nervous system, and pulmonary domains) (only for Population 1).
Have an ESSPRI score of >= 5 at screening (only for Population 2).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 365
Awards & highlights

SS Trial Summary

This trial is to study a new drug for Sjögren's Syndrome to see if it is effective, safe, and tolerated.

Eligible Conditions
  • Sjögren's Syndrome

SS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a score of 5 or more on a test that measures the severity of your Sjogren's syndrome symptoms (excluding certain symptoms). This only applies to a specific group of people in the study.
Select...
You have a high ESSPRI score of 5 or more during screening (only for a specific group of people).

SS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at Day 169 in Population 2
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Day 169 in Population 1
Secondary outcome measures
Change From Baseline in ESSPRI at Day 169 in Population 1
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Day 169 in Populations 1 and 2
Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169 in Populations 1 and 2
+8 more

Side effects data

From 2023 Phase 2 trial • 25 Patients • NCT04046549
22%
COVID-19
17%
Leukopenia
17%
BK virus infection
17%
Anaemia
17%
Hypophosphataemia
13%
Arthralgia
13%
Headache
9%
Urinary tract infection
9%
Metabolic acidosis
9%
Insomnia
9%
Procedural pain
9%
Post procedural urine leak
9%
Hypokalaemia
9%
Neutropenia
9%
Pain in extremity
4%
Bacteraemia
4%
Clostridium difficile infection
4%
Blood creatinine increased
4%
Subcapsular renal haematoma
4%
Cytomegalovirus test positive
4%
Ureteric stenosis
4%
Arteriovenous fistula site complication
4%
Ileus
4%
Cholecystitis acute
4%
Hypervolaemia
4%
Kidney transplant rejection
4%
Depression suicidal
4%
Diabetic foot infection
4%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept+VIB4920

SS 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?

Viela BioLead Sponsor
12 Previous Clinical Trials
946 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
788 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this experiment already begun?

"As per clinicaltrials.gov, this medical trial has stopped recruiting participants at this time; the study was initially posted on October 16th 2019 and most recently revised September 9th 2022. Although there are no recruitment activities for this investigation presently, 1386 other trials require volunteers right now."

Answered by AI

What potential risks have been associated with the use of VIB4920?

"The safety of VIB4920 has been rated a 2. This is because Phase 2 trials indicate that while there are some data points in favor of its security, efficacy remains untested."

Answered by AI

Is the subject pool for this trial inclusive of participants over sixty years in age?

"To abide by this trial's inclusion standards, the lowest eligible age for enrollment is 18 and there exists an upper bound of 75."

Answered by AI

In what quantity of health care facilities is this trial currently underway?

"The trial is currently recruiting from 15 locations across the USA, such as Houston, Lawrenceville and Wheaton. To reduce travel commitments during the study, participants are encouraged to select a centre that is closest to them for enrolment."

Answered by AI

Who is able to qualify for inclusion in this clinical trial?

"This clinical trial requires that participants suffer from sjögren's syndrome and be between 18-75 years old. Accommodating 183 patients, this study is open for enrollment."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Maryland
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
1

Why did patients apply to this trial?

~34 spots leftby Mar 2025