Trial · NCT03100942

Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

NCT03100942, Phase 2, Completed, Gilead Sciences; results first posted 2020-01-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome. Trials, record NCT03100942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03100942

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Trial

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

Title: Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
NCT number: NCT03100942
Status: Completed
Phases: Phase 2
Enrollment: 152 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Sjogren's Syndrome
Interventions: Lanraplenib, Filgotinib, Tirabrutinib, Lanraplenib placebo, Filgotinib placebo, Tirabrutinib placebo
First posted: 2017-04-04
Last updated: 2020-10-23
Other registries' IDs: eudract:2016-003558-34
Results first posted: 2020-01-22
Limitations and caveats: An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline	Week 12	Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as \> 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal \[ULN\] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP \< 1.5 x ULN on Day 1).
Secondary	Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12	Baseline; Week 12	The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Secondary	Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12	Baseline; Week 12	The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Secondary	Change From Baseline in ESSDAI at Week 24	Baseline; Week 24	The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Secondary	Change From Baseline in ESSPRI at Week 24	Baseline; Week 24	The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline	Week 12	The Full Analysis Set included all randomized participants who received at least one dose of study drug. Included participants with available data.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12	Baseline; Week 12	Participants in the Full Analysis Set were analyzed.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12	Baseline; Week 12	Participants in the Full Analysis Set were analyzed.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in ESSDAI at Week 24	Baseline; Week 24	Participants in the Full Analysis Set were analyzed.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in ESSPRI at Week 24	Baseline; Week 24	Participants in the Full Analysis Set were analyzed.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline	Lanraplenib	42.9	95% Confidence Interval 25.0 to 60.7	percentage of participants
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline	Filgotinib	43.2	95% Confidence Interval 25.9 to 60.6	percentage of participants
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline	Tirabrutinib	35.1	95% Confidence Interval 18.4 to 51.9	percentage of participants
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline	Placebo	26.5	95% Confidence Interval 10.2 to 42.8	percentage of participants
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12	Lanraplenib	-2.5	Standard Error 0.76	score on a scale
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12	Filgotinib	-4.7	Standard Error 0.72	score on a scale
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12	Tirabrutinib	-3.2	Standard Error 0.73	score on a scale
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12	Placebo	-3.9	Standard Error 0.76	score on a scale
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12	Lanraplenib	-1.0	Standard Error 0.34	score on a scale
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12	Filgotinib	-1.4	Standard Error 0.33	score on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow42

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

Period	Milestone	Group	Participants
Randomized Treatment Period	STARTED	Lanraplenib	38
Randomized Treatment Period	STARTED	Filgotinib	38
Randomized Treatment Period	STARTED	Tirabrutinib	39
Randomized Treatment Period	STARTED	Placebo	37
Randomized Treatment Period	STARTED	Placebo to Lanraplenib	0
Randomized Treatment Period	STARTED	Placebo to Filgotinib	0
Randomized Treatment Period	STARTED	Placebo to Tirabrutinib	0
Randomized Treatment Period	COMPLETED	Lanraplenib	26
Randomized Treatment Period	COMPLETED	Filgotinib	29
Randomized Treatment Period	COMPLETED	Tirabrutinib	33

1 to 10 of 42Source ClinicalTrials.gov

See all 42 participant flow

Adverse events658

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	Lanraplenib	1	37
other	Anaemia	Blood and lymphatic system disorders	Filgotinib	0	38
other	Anaemia	Blood and lymphatic system disorders	Tirabrutinib	2	39
other	Anaemia	Blood and lymphatic system disorders	Placebo to Lanraplenib	0	10
other	Anaemia	Blood and lymphatic system disorders	Placebo to Filgotinib	0	12
other	Anaemia	Blood and lymphatic system disorders	Placebo to Tirabrutinib	0	10
other	Anaemia	Blood and lymphatic system disorders	Placebo on Placebo Controlled Period	0	36
other	Lymphadenopathy	Blood and lymphatic system disorders	Lanraplenib	2	37
other	Lymphadenopathy	Blood and lymphatic system disorders	Filgotinib	0	38
other	Lymphadenopathy	Blood and lymphatic system disorders	Tirabrutinib	0	39

1 to 10 of 658Source ClinicalTrials.gov

See all 658 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lanraplenib	0	37
Total, all-cause mortality	Filgotinib	0	38
Total, all-cause mortality	Tirabrutinib	0	39
Total, all-cause mortality	Placebo to Lanraplenib	0	10
Total, all-cause mortality	Placebo to Filgotinib	0	12
Total, all-cause mortality	Placebo to Tirabrutinib	0	10
Total, all-cause mortality	Placebo on Placebo Controlled Period	0	36
Total, other adverse events	Lanraplenib	30	37
Total, other adverse events	Filgotinib	31	38
Total, other adverse events	Tirabrutinib	32	39

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35377447	DERIVED

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 comparisons0

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

None in this release.

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.

GET https://conductscience.org/api/trials/v1/NCT03100942

GET https://conductscience.org/api/trials/v1/NCT03100942/flow?page=2

API reference For AI assistants