Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) (NCT NCT03046056)

Last Updated: 2021-08-23

Results Overview

The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of \< 150. A higher score indicates more severe disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

Week 24

Results posted on

2021-08-23

Participant Flow

Participants were enrolled at study sites in the United States, Canada, and Europe. The first participant was screened on 11 April 2017. The last study visit occurred on 20 July 2020.

198 participants were screened.

Participant milestones

Participant milestones
Measure	Filgotinib 200 mg Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Overall Study STARTED	28	32	18
Overall Study COMPLETED	16	16	11
Overall Study NOT COMPLETED	12	16	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Filgotinib 200 mg Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Overall Study Non-responder at Week 10	6	6	4
Overall Study Protocol-specified Disease Worsening	3	3	1
Overall Study Adverse Event	1	5	0
Overall Study Non-compliance With Study Drug	0	0	2
Overall Study Protocol Violation	1	1	0
Overall Study Investigator's Discretion	0	1	0
Overall Study Withdrew Consent	1	0	0

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filgotinib 200 mg n=28 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.	Total n=78 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 16.3 • n=5 Participants	42 years STANDARD_DEVIATION 12.9 • n=7 Participants	45 years STANDARD_DEVIATION 12.9 • n=5 Participants	44 years STANDARD_DEVIATION 14.2 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	23 Participants n=7 Participants	9 Participants n=5 Participants	51 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	25 Participants n=5 Participants	28 Participants n=7 Participants	16 Participants n=5 Participants	69 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Not Permitted	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	26 Participants n=5 Participants	31 Participants n=7 Participants	17 Participants n=5 Participants	74 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	13 participants n=7 Participants	10 participants n=5 Participants	38 participants n=4 Participants
Region of Enrollment Hungary	0 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Czechia	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment Ukraine	2 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants
Region of Enrollment Spain	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Canada	0 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment Austria	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment Italy	3 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment France	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment Germany	0 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Crohn's Disease Activity Index Score (CDAI)	309 score on scale STANDARD_DEVIATION 55.7 • n=5 Participants	297 score on scale STANDARD_DEVIATION 64.9 • n=7 Participants	300 score on scale STANDARD_DEVIATION 63.7 • n=5 Participants	302 score on scale STANDARD_DEVIATION 60.9 • n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Full Analysis Set included all the randomized participants who received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=28 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved Clinical Remission at Week 24	25.0 percentage of participants Interval 12.4 to 41.9	25.0 percentage of participants Interval 13.1 to 40.6	16.7 percentage of participants Interval 4.7 to 37.7

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the Full Analysis Set were analyzed.

Magnetic resonance enterography (MRE) is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and relative contrast enhancement (RCE). A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these components for the terminal ileum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=28 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24	-1.8 score on scale Standard Error 1.51	0.7 score on scale Standard Error 1.39	0.5 score on scale Standard Error 1.64

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the Full Analysis Set were analyzed.

MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=28 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24	-1.1 score on scale Standard Error 1.12	-0.5 score on scale Standard Error 1.08	0.5 score on scale Standard Error 1.26

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the Full Analysis Set were analyzed.

MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system.The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A positive change from baseline indicates disease worsening.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=28 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Change From Baseline in Jejunum Segmental MaRIA Score at Week 24	0.4 score on scale Standard Error 1.00	0.6 score on scale Standard Error 0.95	0.5 score on scale Standard Error 1.12

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in terminal ileum segment at baseline, were analyzed.

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score \< 7 in terminal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=22 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=30 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=16 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24	4.5 percentage of participants Interval 0.2 to 19.8	6.7 percentage of participants Interval 1.2 to 19.5	6.3 percentage of participants Interval 0.3 to 26.4

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in distal ileum segment at baseline, were analyzed.

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score \< 7 in distal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=10 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=8 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=6 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24	10.0 percentage of participants Interval 0.5 to 39.4	0 percentage of participants Interval 0.0 to 31.2	16.7 percentage of participants Interval 0.9 to 58.2

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in jejunum segment at baseline, were analyzed.

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score \< 7 in jejunum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=6 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=8 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=3 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24	33.3 percentage of participants Interval 6.3 to 72.9	0 percentage of participants Interval 0.0 to 31.2	0 percentage of participants Interval 0.0 to 63.2

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in terminal ileum segment at baseline, were analyzed.

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score \< 11 with baseline score ≥ 11, or a segmental MaRIA score \< 7 with baseline score \< 11, or ≥ minimum detectable difference (MDD) units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the terminal ileum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score \< 15, the MDD is 4.0 units.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=22 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=30 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=16 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24	22.7 percentage of participants Interval 9.4 to 42.0	10.0 percentage of participants Interval 2.8 to 23.9	25.0 percentage of participants Interval 9.0 to 48.4

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in distal ileum segment at baseline, were analyzed.

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score \< 11 with baseline score ≥ 11, or a segmental MaRIA score \< 7 with baseline score \< 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score≥ 7 in the distal ileum. For segments with baseline MaRIA score ≥ 15, the minimum detectable difference (MDD) is 6.5 units and for baseline MaRIA score \< 15, the MDD is 4.0 units.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=10 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=8 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=6 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24	20.0 percentage of participants Interval 3.7 to 50.7	12.5 percentage of participants Interval 0.6 to 47.1	16.7 percentage of participants Interval 0.9 to 58.2

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in jejunum segment at baseline, were analyzed.

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score \< 11 with baseline score ≥ 11, or a segmental MaRIA score \< 7 with baseline score \< 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the jejunum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score \< 15, the MDD is 4.0 units.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=6 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=8 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=3 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24	50.0 percentage of participants Interval 15.3 to 84.7	12.5 percentage of participants Interval 0.6 to 47.1	0 percentage of participants Interval 0.0 to 63.2

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in at least 1 small bowel segment at baseline, were analyzed.

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Small bowel MaRIA remission was defined as MaRIA score \< 7 at Week 24 in each of the 3 small bowel segments, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=25 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24	8.0 percentage of participants Interval 1.4 to 23.1	6.3 percentage of participants Interval 1.1 to 18.4	0 percentage of participants Interval 0.0 to 15.3

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with active disease (segmental MaRIA score ≥ 7) in at least 1 small bowel segment at baseline, were analyzed.

The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Participant level small bowel MaRIA response was defined as all small bowel segments with baseline MaRIA score ≥7 achieve segment level MaRIA response, with no segment level disease worsening in any other segment(s) at Week 24, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=25 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24	20.0 percentage of participants Interval 8.2 to 37.5	12.5 percentage of participants Interval 4.4 to 26.4	16.7 percentage of participants Interval 4.7 to 37.7

SECONDARY outcome

Timeframe: Week 10

Population: Participants in the Full Analysis Set were analyzed.

The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of \< 150. A higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=28 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10	39.3 percentage of participants Interval 23.8 to 56.5	25.0 percentage of participants Interval 13.1 to 40.6	22.2 percentage of participants Interval 8.0 to 43.9

SECONDARY outcome

Timeframe: Baseline; Week 10

Population: Participants in the Full Analysis Set with available data were analyzed.

The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. A score of \< 150 indicates remission. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=28 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Change From Baseline in CDAI Scores at Week 10	-105 score on scale Standard Error 23.6	-88 score on scale Standard Error 22.3	-57 score on scale Standard Error 26.2

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The score ranges from 0 to 600. A score of \< 150 indicates remission. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=28 Participants Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 Participants Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 Participants PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Change From Baseline in CDAI Scores at Week 24	-86 score on scale Standard Error 24.1	-71 score on scale Standard Error 22.8	-66 score on scale Standard Error 26.7

Adverse Events

Filgotinib 200 mg

Serious events: 4 serious events

Other events: 20 other events

Deaths: 1 deaths

Filgotinib 100 mg

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Filgotinib 200 mg n=28 participants at risk Filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 27 weeks.	Filgotinib 100 mg n=32 participants at risk Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet orally once daily for up to 26.3 weeks.	Placebo n=18 participants at risk PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet orally once daily for up to 28.7 weeks.
Gastrointestinal disorders Crohn's disease	7.1% 2/28 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 4/32 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Ileus	0.00% 0/28 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.1% 1/32 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	7.1% 2/28 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/32 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Anal abscess	0.00% 0/28 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.1% 1/32 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/28 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.1% 1/32 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • All-Cause Mortality: First dose date up to last dose date (maximum: 28.7 weeks) plus 59 days; Adverse Events: First dose date up to last dose date (maximum: 28.7 weeks) plus 30 days All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study; Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug.

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER