A Phase 2 interventional study of Filgotinib and Placebo to match filgotinib in Small Bowel Crohn's Disease, sponsored by Gilead Sciences. Completed at 38 sites in 12 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 78 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks.
Drug: Filgotinib · Drug: Placebo to match filgotinib
Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks.
Drug: Filgotinib · Drug: Placebo to match filgotinib
PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks.
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Also known as: GS-6034, GLPG0634
Tablet(s) administered orally once daily
Percentage of Participants Who Achieved Clinical Remission at Week 24
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.
Time frame: Week 24
Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24
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.
Time frame: Baseline; Week 24
Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24
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.
Time frame: Baseline; Week 24
Change From Baseline in Jejunum Segmental MaRIA Score at Week 24
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.
Time frame: Baseline; Week 24
Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24
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.
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24
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.
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24
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.
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24
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.
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24
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.
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24
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.
Time frame: Week 24
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24
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.
Time frame: Week 24
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24
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.
Time frame: Week 24
Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
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.
Time frame: Week 10
Change From Baseline in CDAI Scores at Week 10
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.
Time frame: Baseline; Week 10
Change From Baseline in CDAI Scores at Week 24
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.
Time frame: Baseline; Week 24
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.
| Milestone | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Started | 28 | 32 | 18 |
| Completed | 16 | 16 | 11 |
| Not completed | 12 | 16 | 7 |
| Withdrew: Non-responder at week 10 | 6 | 6 | 4 |
| Withdrew: Protocol-specified disease worsening | 3 | 3 | 1 |
| Withdrew: Adverse event | 1 | 5 | 0 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 2 |
| Withdrew: Protocol violation | 1 | 1 | 0 |
| Withdrew: Investigator's discretion | 0 | 1 | 0 |
| Withdrew: Withdrew consent | 1 | 0 | 0 |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved Clinical Remission at Week 24 | 25.0 (12.4 to 41.9) | 25.0 (13.1 to 40.6) | 16.7 (4.7 to 37.7) |
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.
| score on scale | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24 | -1.8 ± 1.51 | 0.7 ± 1.39 | 0.5 ± 1.64 |
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.
| score on scale | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24 | -1.1 ± 1.12 | -0.5 ± 1.08 | 0.5 ± 1.26 |
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.
| score on scale | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Jejunum Segmental MaRIA Score at Week 24 | 0.4 ± 1.00 | 0.6 ± 0.95 | 0.5 ± 1.12 |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24 | 4.5 (0.2 to 19.8) | 6.7 (1.2 to 19.5) | 6.3 (0.3 to 26.4) |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24 | 10.0 (0.5 to 39.4) | 0 (0.0 to 31.2) | 16.7 (0.9 to 58.2) |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24 | 33.3 (6.3 to 72.9) | 0 (0.0 to 31.2) | 0 (0.0 to 63.2) |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24 | 22.7 (9.4 to 42.0) | 10.0 (2.8 to 23.9) | 25.0 (9.0 to 48.4) |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24 | 20.0 (3.7 to 50.7) | 12.5 (0.6 to 47.1) | 16.7 (0.9 to 58.2) |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24 | 50.0 (15.3 to 84.7) | 12.5 (0.6 to 47.1) | 0 (0.0 to 63.2) |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24 | 8.0 (1.4 to 23.1) | 6.3 (1.1 to 18.4) | 0 (0.0 to 15.3) |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24 | 20.0 (8.2 to 37.5) | 12.5 (4.4 to 26.4) | 16.7 (4.7 to 37.7) |
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.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | 39.3 (23.8 to 56.5) | 25.0 (13.1 to 40.6) | 22.2 (8.0 to 43.9) |
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.
| score on scale | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in CDAI Scores at Week 10 | -105 ± 23.6 | -88 ± 22.3 | -57 ± 26.2 |
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.
| score on scale | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in CDAI Scores at Week 24 | -86 ± 24.1 | -71 ± 22.8 | -66 ± 26.7 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Filgotinib 200 mg | 1/28 (3.6%) | 4/28 (14.3%) | 20/28 (71.4%) |
| Filgotinib 100 mg | 0/32 (0%) | 7/32 (21.9%) | 24/32 (75%) |
| Placebo | 0/18 (0%) | 0/18 (0%) | 13/18 (72.2%) |
| Event | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Crohn's diseaseGastrointestinal disorders | 2/28 | 4/32 | 0/18 |
| Small intestinal obstructionGastrointestinal disorders | 2/28 | 0/32 | 0/18 |
| IleusGastrointestinal disorders | 0/28 | 1/32 | 0/18 |
| Anal abscessInfections and infestations | 0/28 | 1/32 | 0/18 |
| PneumoniaInfections and infestations | 0/28 | 1/32 | 0/18 |
| Event | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 5/28 | 6/32 | 1/18 |
| Crohn's diseaseGastrointestinal disorders | 4/28 | 6/32 | 2/18 |
| NauseaGastrointestinal disorders | 5/28 | 3/32 | 1/18 |
| SinusitisInfections and infestations | 4/28 | 0/32 | 1/18 |
| HeadacheNervous system disorders | 4/28 | 4/32 | 2/18 |
| NasopharyngitisInfections and infestations | 0/28 | 4/32 | 0/18 |
| VomitingGastrointestinal disorders | 1/28 | 2/32 | 2/18 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/28 | 1/32 | 2/18 |
| DizzinessNervous system disorders | 1/28 | 2/32 | 2/18 |
| InfluenzaInfections and infestations | 3/28 | 1/32 | 0/18 |
Safety Analysis Set included all participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 46 ± 16.3 | 42 ± 12.9 | 45 ± 12.9 | 44 ± 14.2 |
| Sex: Female, Male(Participants) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 19 | 23 | 9 | 51 |
| Male | 9 | 9 | 9 | 27 |
| Race/Ethnicity, Customized(Participants) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Race — Asian | 0 | 0 | 0 | 0 |
| Race — Black or African American | 2 | 4 | 2 | 8 |
| Race — Native Hawaiian or Pacific Islander | 0 | 0 | 0 | 0 |
| Race — White | 25 | 28 | 16 | 69 |
| Race — Other | 1 | 0 | 0 | 1 |
| Race — Not Permitted | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Ethnicity — Not Hispanic or Latino | 26 | 31 | 17 | 74 |
| Ethnicity — Hispanic or Latino | 2 | 1 | 1 | 4 |
| Ethnicity — Not Permitted | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| United States | 15 | 13 | 10 | 38 |
| Hungary | 0 | 3 | 1 | 4 |
| Czechia | 0 | 1 | 0 | 1 |
| Ukraine | 2 | 0 | 1 | 3 |
| United Kingdom | 4 | 1 | 2 | 7 |
| Spain | 1 | 2 | 0 | 3 |
| Canada | 0 | 4 | 1 | 5 |
| Austria | 1 | 1 | 0 | 2 |
| Belgium | 0 | 2 | 0 | 2 |
| Italy | 3 | 1 | 1 | 5 |
| France | 2 | 2 | 1 | 5 |
| Germany | 0 | 2 | 1 | 3 |
| Crohn's Disease Activity Index Score (CDAI)(score on scale) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 309 ± 55.7 | 297 ± 64.9 | 300 ± 63.7 | 302 ± 60.9 |
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gilead Sciences