Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome (NCT NCT04129164)

Participants were recruited across 70 international sites between November 2019 and March 2023.

Eligibility for Sjögren's syndrome (SS) was assessed using the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria. Participants were then randomized into a double-blind treatment period and categorized into two populations based on the severity of systemic disease activity and symptoms.

The baseline ESSDAI total score for Population 1 is reported to support the primary outcome measure and is not collected for the overall study population.

The ESSDAI is a systemic disease activity index for SS, assessing 12 domains (Constitutional, Salivary Glands, Lungs, Kidneys, Musculoskeletal, Peripheral Nervous System, Central Nervous System, Vascular, Gastrointestinal, Hematological, Ocular, and Extraglandular Manifestations). Each domain is graded for activity (0 = no activity to 3 = high activity) and weighted (1 for Biological to 6 for Muscular) based on its clinical significance, with the final score calculated as the sum of all weighted domain scores. The theoretical range is 0 to 123, with disease activity categorized as low (\<5), moderate (5-13), and high (≥14). A positive change form baseline represents an increase in symptoms.

The ESSPRI is a self-assessment tool for evaluating symptoms of dryness, fatigue, and pain (articular and/or muscular) in SS. Participants rate each of the three domains on a 0-10 numerical scale (0 = no; 10 maximal imaginable severity). All domains are equally weighted, and the total score is the mean of the three domain scores. The maximum total score for the ESSPRI assessment is 10. A positive change form baseline represents an increase in symptoms.

The ESSPRI is a self-assessment tool for evaluating symptoms of dryness, fatigue, and pain (articular and/or muscular) in SS. Participants rate each of the three domains on a 0-10 numerical scale (0 = no; 10 maximal imaginable severity). All domains are equally weighted, and the total score is the mean of the three domain scores. The maximum total score for the ESSPRI assessment is 10. A positive change from baseline represents an increase in symptoms.

The ESSDAI is a systemic disease activity index for primary Sjögren's syndrome, assessing 12 domains (e.g., cutaneous, renal, CNS, and biological). Each domain is graded for activity (0 = no activity to 3 = high activity) and weighted (1 for Biological to 6 for Muscular) based on its clinical significance, with the final score calculated as the sum of all weighted domain scores. The theoretical range is 0 to 123, with disease activity categorized as low (\<5), moderate (5-13), and high (≥14). A positive change from baseline represents an increase in symptoms. ESSEDAI\[3\] and \[4\] responses were defined as a decrease of at least 3 or 4 points respectively in the ESSDAI score from the baseline value, measured at Day 169.

The FACIT-Fatigue is a 13-item patient-reported questionnaire designed to assess the impact of fatigue on quality of life (QoL). Responses are scored from 0 (Not at all) to 4 (Very Much). The total score is the sum of all responses, ranging from 0 to 52, with higher scores indicating better QoL. A positive change from baseline represents an increase in QoL.

The OSDI is a validated tool for assessing vision-related function and dry eye disease severity (normal, mild, moderate, severe). It consists of 12 questions, with responses ranging from 0 (None of the time) to 4 (All of the time). Scores range from 0 to 100, as it is calculated by transforming the raw responses from the 12 questions into a standardized 0-100 scale, with higher scores indicating greater disability. A positive change from baseline indicates a worsening vision-related function.

The PGIS is a single-item measure that captures a patient's perception of overall symptom severity over the past week, using a 5-point categorical response scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe), with higher scores indicating greater symptom severity. Positive change from baseline values indicate worsening of symptoms severity.

The ESSPRI is a self-assessment tool for evaluating symptoms of dryness, fatigue, and pain (articular and/or muscular) in SS. Participants rate each of the three domains on a 0-10 numerical scale (0 = no; 10 maximal imaginable severity). All domains are equally weighted, and the total score is the mean of the three domain scores. The maximum total score for the ESSPRI assessment is 10. A positive change form baseline represents an increase in symptoms. Participants achieving an ESSPRI response were defined as at least a 1 point or 15% reduction from baseline in ESSPRI score at Day 169 without premature discontinuation from the study and without receiving rescue medications.

An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events. AEs were graded (Grade 3: severe; Grade 4: life-threatening; Grade 5: death) using the Common Terminology Criteria for Adverse Events (CTCAE).

Blood samples were collected at the specified time points.