Study Complete
Sponsor ID
VIB4920.P2.S2

A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren’s SyndromeSS

Sponsor ID
VIB4920.P2.S2
Clinicaltrials.gov ID
NCT04129164
EUCTIS ID
N/A
EudraCT ID
2019-002713-19

Study Details

The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren’s Syndrome (SS).

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
183
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change From Baseline in European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) at Day 169 in Population 1

Timeframe: Baseline (Day 1) and Day 169

Change From Baseline in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) at Day 169 in Population 2

Timeframe: Baseline (Day 1) and Day 169

Secondary Outcome Measures

Change From Baseline in ESSPRI at Day 169 in Population 1

Timeframe: Baseline (Day 1) and Day 169

Percentage of Participants achieving ESSDAI [3] and ESSDAI [4] response in Population 1

Timeframe: Baseline (Day 1) to Day 169

Percentage of Participants achieving ESSPRI response in Population 2

Timeframe: Baseline (Day 1) to Day 169

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Day 169 in Populations 1 and 2

Timeframe: Baseline (Day 1) and Day 169

Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169 in Populations 1 and 2

Timeframe: Baseline (Day 1) and Day 169

Patient’s Global Impression of Severity at Day 169 in Populations 1 and 2

Timeframe: Day 169

Number of participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Populations 1 and 2

Timeframe: From Baseline (Day 1) up to Day 365

Number of participants With Adverse Events of Special Interest (AESIs) in Populations 1 and 2

Timeframe: From Baseline (Day 1) up to Day 365

Number of Participants With Abnormal Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs) Reported as TEAEs in Populations 1 and 2

Timeframe: From Baseline (Day 1) up to Day 365

Plasma Concentration of VIB4920

Timeframe: Day 1 to Day 365

Percentage of Participants With Positive Antibody Titer to VIB4920 in Populations 1 and 2

Timeframe: Day 1 to Day 365

Locations

Location
Status
Contact Us
Location
Research Site
Fullerton, California, United States, 92835
Status
Active, not recruiting
Location
Research site
Upland, California, United States, 91786
Status
Active, not recruiting
Location
Research Site
Lawrenceville, Georgia, United States, 30046
Status
Active, not recruiting
Location
Research Site
Kansas City, Kansas, United States, 66160
Status
Active, not recruiting
Location
Research Site
Baltimore, Maryland, United States, 21224
Status
Active, not recruiting
Location
Research Site
Wheaton, Maryland, United States, 20902
Status
Active, not recruiting
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