Trial · NCT04129164

A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

NCT04129164, Phase 2, Completed, Amgen; results first posted 2025-04-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome. Trials, record NCT04129164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04129164

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome
NCT number: NCT04129164
Status: Completed
Phases: Phase 2
Enrollment: 183 participants, actual
Lead sponsor: Amgen
Conditions: Sjögren's Syndrome
Interventions: VIB4920, Placebo
First posted: 2019-10-16
Last updated: 2025-04-30
Other registries' IDs: eudract:2019-002713-19
Results first posted: 2025-04-30

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Population 1: Change From Baseline in ESSDAI at Day 169	Baseline and Day 169	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.
Primary	Population 2: Change From Baseline in ESSPRI at Day 169	Baseline and Day 169	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.
Secondary	Population 1: Change From Baseline in ESSPRI at Day 169	Baseline and Day 169	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.
Secondary	Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169	Day 169	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.
Secondary	Change From Baseline in The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Day 169	Baseline and 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.
Secondary	Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169	Baseline and Day 169	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.
Secondary	Patient Global Impression of Severity (PGIS) Score at Day 169	Baseline and Day 169	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.
Secondary	Population 2: Number of Participants Who Achieved ESSPRI Response at Day 169	Day 169	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.
Secondary	Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)	Up to approximately 365 days	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).
Secondary	Serum Concentration of VIB4920	Day 1 pre-dose, Day 1 post-dose, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141 pre-dose, Day 141 post-dose, Day 169 pre-dose, Day 169 post-dose, Day 197, Day 225, Day 253, Day 281, Day 309, Day 365	Blood samples were collected at the specified time points.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Population 1: Change From Baseline in ESSDAI at Day 169	Baseline and Day 169	FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.	Score on scale	LEAST_SQUARES_MEAN
PRIMARY	Population 2: Change From Baseline in ESSPRI at Day 169	Baseline and Day 169	FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Population 1: Change From Baseline in ESSPRI at Day 169	Baseline and Day 169	FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169	Day 169	FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Day 169	Baseline and Day 169	FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169	Baseline and Day 169	FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Patient Global Impression of Severity (PGIS) Score at Day 169	Baseline and Day 169	FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Population 2: Number of Participants Who Achieved ESSPRI Response at Day 169	Day 169	FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)	Up to approximately 365 days	Safety Analysis Set: included all participants who received any dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Serum Concentration of VIB4920	Day 1 pre-dose, Day 1 post-dose, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141 pre-dose, Day 141 post-dose, Day 169 pre-dose, Day 169 post-dose, Day 197, Day 225, Day 253, Day 281, Day 309, Day 365	Pharmacokinetic (PK) Analysis Set: included all participants who received investigational product and had at least one quantifiable plasma PK observation post-first dose.	mg/L	MEAN

Source ClinicalTrials.gov

Results by group106

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Population 1: Change From Baseline in ESSDAI at Day 169	Population 1: Placebo		-4.1	Standard Error 0.6	Score on scale
Population 1: Change From Baseline in ESSDAI at Day 169	Population 1: VIB4920		-6.3	Standard Error 0.6	Score on scale
Population 2: Change From Baseline in ESSPRI at Day 169	Population 2: Placebo		-0.53	Standard Error 0.23	Score on scale
Population 2: Change From Baseline in ESSPRI at Day 169	Population 2: VIB4920		-1.80	Standard Error 0.23	Score on scale
Population 1: Change From Baseline in ESSPRI at Day 169	Population 1: Placebo		-1.12	Standard Error 0.29	Score on scale
Population 1: Change From Baseline in ESSPRI at Day 169	Population 1: VIB4920		-1.80	Standard Error 0.31	Score on scale
Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169	Population 1: Placebo	ESSDAI[3] Day 169	22		Participants
Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169	Population 1: VIB4920	ESSDAI[3] Day 169	26		Participants
Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169	Population 1: Placebo	ESSDAI[4] Day 169	18		Participants
Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169	Population 1: VIB4920	ESSDAI[4] Day 169	24		Participants

1 to 10 of 106Source ClinicalTrials.gov

See all 106 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Population 1: Placebo/VIB4920	38
Overall Study	STARTED	Population 1: VIB4920/Placebo	36
Overall Study	STARTED	Population 2: Placebo/VIB4920	55
Overall Study	STARTED	Population 2: VIB4920/Placebo	54
Overall Study	Completed Stage I	Population 1: Placebo/VIB4920	37
Overall Study	Completed Stage I	Population 1: VIB4920/Placebo	34
Overall Study	Completed Stage I	Population 2: Placebo/VIB4920	52
Overall Study	Completed Stage I	Population 2: VIB4920/Placebo	49
Overall Study	COMPLETED	Population 1: Placebo/VIB4920	35
Overall Study	COMPLETED	Population 1: VIB4920/Placebo	32

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events360

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Population 1: Placebo (Stage I)	1	38
other	Anaemia	Blood and lymphatic system disorders	Population 1: VIB4920 (Stage I)	0	36
other	Anaemia	Blood and lymphatic system disorders	Population 1: VIB4920 (Stage II)	1	37
other	Anaemia	Blood and lymphatic system disorders	Population 1: Placebo (Stage II)	0	34
other	Anaemia	Blood and lymphatic system disorders	Population 2: Placebo (Stage I)	2	55
other	Anaemia	Blood and lymphatic system disorders	Population 2: VIB4920 (Stage I)	4	54
other	Anaemia	Blood and lymphatic system disorders	Population 2: VIB4920 (Stage II)	0	52
other	Anaemia	Blood and lymphatic system disorders	Population 2: Placebo (Stage II)	1	49
other	Abdominal pain	Gastrointestinal disorders	Population 1: Placebo (Stage I)	2	38
other	Abdominal pain	Gastrointestinal disorders	Population 1: VIB4920 (Stage I)	0	36

1 to 10 of 360Source ClinicalTrials.gov

See all 360 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Population 1: Placebo (Stage I)	0	38
Total, all-cause mortality	Population 1: VIB4920 (Stage I)	1	36
Total, all-cause mortality	Population 1: VIB4920 (Stage II)	0	37
Total, all-cause mortality	Population 1: Placebo (Stage II)	0	34
Total, all-cause mortality	Population 2: Placebo (Stage I)	0	55
Total, all-cause mortality	Population 2: VIB4920 (Stage I)	0	54
Total, all-cause mortality	Population 2: VIB4920 (Stage II)	0	52
Total, all-cause mortality	Population 2: Placebo (Stage II)	0	49
Total, other adverse events	Population 1: Placebo (Stage I)	18	38
Total, other adverse events	Population 1: VIB4920 (Stage I)	20	36

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38839899	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Population 2: VIB4920 vs Population 2: Placebo: Population 2: Number of Participants Who Achieved ESSPRI Response at Day 169

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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