Study to Evaluate the Efficacy and Safety of Filgotinib i... | NCT02914522 | Trialant
NCT02914522
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Apr 21, 2021Actual
Enrollment
1,351Actual
Phase
Phase 3
Conditions
Ulcerative Colitis
Interventions
Filgotinib
PTM filgotinib
Countries
United States
Argentina
Australia
Austria
Belgium
Bulgaria
Canada
Croatia
Czechia
France
Georgia
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Japan
Malaysia
Mexico
Netherlands
New Zealand
Norway
Poland
Portugal
Romania
Russia
Serbia
Singapore
Slovakia
South Africa
South Korea
Spain
Sweden
Switzerland
Taiwan
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02914522
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-418-3898
Secondary IDs
ID
Type
Description
Link
2016-001392-78
EudraCT Number
Brief Title
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Official Title
Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Acronym
SELECTION
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Mar 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 14, 2016Actual
Primary Completion Date
Mar 31, 2020Actual
Completion Date
Mar 31, 2020Actual
First Submitted Date
Sep 22, 2016
First Submission Date that Met QC Criteria
Sep 22, 2016
First Posted Date
Sep 26, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 23, 2021
Results First Submitted that Met QC Criteria
Mar 23, 2021
Results First Posted Date
Apr 21, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 23, 2021
Last Update Posted Date
Apr 21, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Name
Class
Lakefront Biotherapeutics NV
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.
Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,351Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Induction Study (Cohort A): Filgotinib 200 mg
Experimental
Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.
Drug: Filgotinib
Drug: PTM filgotinib
Induction Study (Cohort A): Filgotinib 100 mg
Experimental
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Drug: Filgotinib
Drug: PTM filgotinib
Induction Study (Cohort A): Placebo
Placebo Comparator
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Drug: PTM filgotinib
Induction Study (Cohort B): Filgotinib 200 mg
Experimental
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Drug: Filgotinib
Drug: PTM filgotinib
Induction Study (Cohort B): Filgotinib 100 mg
Experimental
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Filgotinib
Drug
Tablet(s) administered orally once daily
Induction Study (Cohort A): Filgotinib 100 mg
Induction Study (Cohort A): Filgotinib 200 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Week 10
Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Week 58
Secondary Outcomes
Measure
Description
Time Frame
Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10
MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
Moderately to severely active UC
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): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
Key Exclusion Criteria:
Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
Active tuberculosis (TB) or history of latent TB that has not been treated
Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Magro F, Rogler G, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Cougnaud L, Faes M, Bauer Y, Randall M, Rudolph C, Reinisch W. Association between endo-histological outcomes and colonic mucosal transcriptomic profiles in patients with ulcerative colitis receiving filgotinib. J Crohns Colitis. 2026 Feb 5;20(2):jjaf228. doi: 10.1093/ecco-jcc/jjaf228.
Participants were enrolled at study sites in Australia, New Zealand, North America, South America, Asia and Europe. The first participant was screened on 14 November 2016. The last study visit occurred on 31 March 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.
FG001
Induction Study (Cohort A): Filgotinib 100 mg
Periods
Title
Milestones
Reasons Not Completed
Induction Study: Up to Week 11
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 2, 2019
Jan 29, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Iceland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Filgotinib
Drug: PTM filgotinib
Induction Study (Cohort B): Placebo
Placebo Comparator
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Drug: PTM filgotinib
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Experimental
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58).
Drug: Filgotinib
Drug: PTM filgotinib
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Placebo Comparator
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Drug: PTM filgotinib
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Experimental
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58).
Drug: Filgotinib
Drug: PTM filgotinib
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Placebo Comparator
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Drug: PTM filgotinib
Maintenance Study: Placebo From Induction Placebo
Placebo Comparator
Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58).
Drug: PTM filgotinib
Induction Study (Cohort B): Filgotinib 100 mg
Induction Study (Cohort B): Filgotinib 200 mg
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
GS-6034
GLPG0634
PTM filgotinib
Drug
Tablet(s) administered orally once daily
Induction Study (Cohort A): Filgotinib 100 mg
Induction Study (Cohort A): Filgotinib 200 mg
Induction Study (Cohort A): Placebo
Induction Study (Cohort B): Filgotinib 100 mg
Induction Study (Cohort B): Filgotinib 200 mg
Induction Study (Cohort B): Placebo
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Maintenance Study: Placebo From Induction Placebo
Week 10
Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10
Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Week 10
Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10
Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Week 10
Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10
MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Week 10
Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845
Cmax is defined as the maximum observed concentration of drug.
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845
Tmax is defined as the time to reach maximum observed concentration of drug.
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58
MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58
Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58.
Week 58
Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58
Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58
Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Week 58
Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58
Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Week 58
Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58
MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Week 58
Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845
Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845.
Week 26 (any Time) and Week 58 (predose)
Scottsdale
Arizona
85259
United States
VA Long Beach Healthcare System
Long Beach
California
90822
United States
Cedars Sinai Medical Center
Los Angeles
California
90048
United States
South Denver Gastroenterology, PC
Lone Tree
Colorado
80124
United States
Connecticut GI PC-Research Division
Farmington
Connecticut
06032
United States
UF Health at Shands Hospital
Gainesville
Florida
32610
United States
Florida Research Institute
Lakewood Rch
Florida
34211
United States
University of Miami Crohn's and Colitis Center
Miami
Florida
33136
United States
Cordova Research Institute
Miami
Florida
33155
United States
Gastroenterology Group of Naples
Naples
Florida
34102
United States
Advanced Medical Research Center
Port Orange
Florida
32127
United States
Tampa General Hospital
Tampa
Florida
33606
United States
Shafran Gastroenterology Center
Winter Park
Florida
32789
United States
Florida Medical Clinic, P.A.
Zephyrhills
Florida
33540
United States
Gastroenterology Associates of Central Georgia, LLC
Macon
Georgia
31201
United States
Gastrointestinal Specialists of Georgia
Marietta
Georgia
30060
United States
Atlanta Gastroenterology Specialist, PC
Suwanee
Georgia
30024
United States
University of Iowa Hospitals and Clinics
Iowa City
Iowa
52242
United States
University of Louisville, Clinical Trials Unit
Louisville
Kentucky
40202
United States
Delta Research Partners, LLC
Monroe
Louisiana
71201
United States
Louisiana Research Center, LLC
Shreveport
Louisiana
71105
United States
Investigative Clinical Research
Annapolis
Maryland
21401
United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase
Maryland
20815
United States
Gastro Center of Maryland
Columbia
Maryland
21045
United States
Meritus Center for Clinical Research
Hagerstown
Maryland
21742
United States
Massachusetts General Hospital - Crohn's and Colitis Center
Boston
Massachusetts
02114
United States
Clinical Research Institute of Michigan, LLC
Chesterfield
Michigan
48047
United States
Center for Digestive Health
Troy
Michigan
48098
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Kansas City Research Institute
Kansas City
Missouri
64131
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
NY Scientific
Brooklyn
New York
11235
United States
NYU Langone Long Island Clinical Research Associates
Great Neck
New York
11021
United States
Carolina's GI Research, LLC
Raleigh
North Carolina
27607
United States
Fargo Gastroenterology and Hepatology Clinic
Fargo
North Dakota
58103
United States
Consultants for Clinical Research
Cincinnati
Ohio
45219
United States
UC Health Physicians Clifton
Cincinnati
Ohio
45219
United States
Great Lakes Gastroenterology Research, LLC
Mentor
Ohio
44060
United States
Gastroenterology Associates of Orangeburg
Orangeburg
South Carolina
29118
United States
Rapid City Medical Center
Rapid City
South Dakota
57701
United States
WR-ClinSearch, LLC
Chattanooga
Tennessee
37421
United States
Gastro One
Germantown
Tennessee
38138
United States
Quality Medical Research
Nashville
Tennessee
37211
United States
Vanderbilt University Medical Center - IBD Clinic
Nashville
Tennessee
37212-1375
United States
San Antonio Military Medical Center
Fort Sam Houston
Texas
78219
United States
DHAT Research Institute
Garland
Texas
75044
United States
Baylor College of Medicine- Baylor Medical Center
Houston
Texas
77030
United States
The University of Texas Health Science Center at Houston
Houston
Texas
77030
United States
Clinical Associates in Research Therapeutics of America, LLC
San Antonio
Texas
78212
United States
Gastroenterology Research of San Antonio
San Antonio
Texas
78229
United States
Texas Digestive Disease Consultants
San Marcos
Texas
78666
United States
Texas Digestive Disease Consultants
Southlake
Texas
76092
United States
Spring Gastroenterology
The Woodlands
Texas
77380
United States
HP Clinical Research
Bountiful
Utah
84010
United States
University of Virginia Health System
Charlottesville
Virginia
22908
United States
Gastroenterology Associates Of Tidewater
Chesapeake
Virginia
23320
United States
Emeritas Research Group LLC
Lansdowne Town Center
Virginia
20176
United States
McGuire DVAMC
Richmond
Virginia
23249
United States
University of Wisconsin Hospital & Clinics
Madison
Wisconsin
53705
United States
Allegiance Research Specialists, LLC
Wauwatosa
Wisconsin
53225
United States
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata
B7600FZN
Argentina
Instituto Médico Cer
Quilmes
B1878
Argentina
St. Vincent's Hospital Sydney
Darlinghurst
New South Wales
2010
Australia
Nepean Hospital
Kingswood
New South Wales
2747
Australia
Coastal Digestive Health
Mountain Creek
Queensland
4557
Australia
Mater Misericordiae Ltd
South Brisbane
Queensland
4101
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
4102
Australia
The Queen Elizabeth Hospital
Woodville South
South Australia
5011
Australia
Monash Medical Centre
Clayton
Victoria
3168
Australia
Footscray Hospital
Footscray
Victoria
3011
Australia
Austin Health
Heidelberg
Victoria
3084
Australia
Cabrini Hospital
Malvern
Victoria
3144
Australia
Alfred Hospital
Melbourne
Victoria
3004
Australia
Universitatsklinik Innsbruck
Innsbruck
6020
Austria
AKH-Medizinische Universitat Wien
Vienna
1090
Austria
GZA Ziekenhuizen campus Sint-Vincentius
Antwerp
2018
Belgium
CUB Hopital Erasme
Brussels
1070
Belgium
Universitair Ziekenhuis Leuven
Leuven
B-3000
Belgium
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège
4000
Belgium
MHAT Sveti Pantaleymon - Pleven OOD
Pleven
5800
Bulgaria
"MDHAT Dr. St.Cherkezov" AD
Veliko Tarnovo
5000
Bulgaria
MHAT "Sveta Petka" AD
Vidin
3700
Bulgaria
University of Calgary, Heritage Medical Research Clinic
Calgary
Alberta
T2N 4Z6
Canada
The Gordon and Leslie Diamond Health Care Centre
Vancouver
British Columbia
V5Z 1M9
Canada
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
Bucharest
020125
Romania
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
Oradea
410066
Romania
Cabinet Particular Policlinic Algomed SRL
Timișoara
300002
Romania
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
Chelyabinsk
454076
Russia
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
Irkutsk
669079
Russia
Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
Moscow
115446
Russia
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
Moscow
127015
Russia
State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
Moscow
129110
Russia
State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
Nizhny Novgorod
603126
Russia
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk
630084
Russia
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk
630087
Russia
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
Saint Petersburg
191015
Russia
"Riat" LLC
Saint Petersburg
193163
Russia
"Scientific Research Centre ECO-safety" LLC
Saint Petersburg
196143
Russia
"PolyClinic EXPERT" LLC
Saint Petersburg
197110
Russia
State Healthcare Institution "Regional Clinical Hospital"
Saratov
410053
Russia
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
Smolensk
214019
Russia
State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center"
Tyumen
625026
Russia
Zvezdara University Medical Center
Belgrade
3810-971
Serbia
Singapore General Hospital
Singapore
169608
Singapore
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra
950 01
Slovakia
Dr MJ Prins
Cape Town
7500
South Africa
Peermed Clinical Trial Centre
Johannesburg
1619
South Africa
The Catholic University of Korea, St. Vincent's Hospital
Suwon
Gyeonggi-do
16247
South Korea
Pusan National University Hospital
Busan
609801
South Korea
Yeungnam University Hospital
Daegu
42415
South Korea
Kangbuk Samsung Hospital
Seoul
03181
South Korea
Yonsei University Health System, Severance Hospital
Seoul
03722
South Korea
Asan Medical Center
Seoul
05505
South Korea
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
Seoul
06351
South Korea
Hyung Hee University Hospital
Seoul
130-872
South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju
220-701
South Korea
Centro Medico Teknon
Barcelona
08022
Spain
Hospital Clinico San Carlos
Madrid
28040
Spain
Hospital Universitario de Fuenlabrada
Madrid
28942
Spain
Hospital Universitario Central de Asturias
Oviedo
33006
Spain
Hospital Universitario Virgen del Rocio
Seville
41013
Spain
Danderyds Sjukhus AB
Danderyd
SE-18288
Sweden
Skane University Hospital
Malmö
SE-205-02
Sweden
Akademiska Sjukhuset
Uppsala
75185
Sweden
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern
3012
Switzerland
Universitatsspital Zurich
Zurich
8091
Switzerland
Changhua Christian Hospital
Chang-hua
500
Taiwan
National Taiwan University Hospital
Taipei
100
Taiwan
Mackay Memorial Hospital, Taipei
Taipei
10449
Taiwan
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan
33305
Taiwan
Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
Cherkasy
18000
Ukraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
Chernivtsi
58000
Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
Chernivtsi
58000
Ukraine
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
Dnipropetrovsk
49000
Ukraine
Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
Ivano-Frankivsk
76000-490
Ukraine
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
Kharkiv
61037
Ukraine
L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
Kharkiv
61039
Ukraine
Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
Kharkiv
63101
Ukraine
Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
Kropyvnytskyi
25006
Ukraine
Kyiv City Clinical Hospital No. 18, Proctology Department
Kyiv
01030
Ukraine
Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
Kyiv
1103
Ukraine
Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
Odesa
65010
Ukraine
Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
Odesa
65025
Ukraine
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
Ternopil
46002
Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia
21005
Ukraine
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia
21018
Ukraine
Medical Center LLC "Health Clinic"
Vinnytsia
21029
Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya
69600
Ukraine
The Pennine Acute Hospitals NHS Trust
Bury
BL9 7TD
United Kingdom
Cambridge University Hospital NHS Foundation Trust
Cambridge
CB2 0QQ
United Kingdom
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
NHS Lothian
Edinburgh
EH4 2XU
United Kingdom
Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
Glasgow
G51 4TF
United Kingdom
NHS Greater Glasgow and Clyde
Glasgow
G52 3NQ
United Kingdom
Wycombe Hospital
High Wycombe
HP11 2TT
United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
London
W2 1NY
United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
NR4 7UY
United Kingdom
Biomedical Research Unit
Nottingham
NG7 2UH
United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford
OX3 9DU
United Kingdom
St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot
L35 5DR
United Kingdom
Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
Southampton
SO16 6YD
United Kingdom
Derived
Louis E, Schreiber S, Hisamatsu T, Hibi T, Jamoul C, Muller K, Taliadouros V, Oortwijn A, Peyrin-Biroulet L, Feagan BG. Factors associated with response to filgotinib and the prognostic power of faecal calprotectin for ulcerative colitis in the phase 2b/3 SELECTION trial. Dig Liver Dis. 2025 Jul;57(7):1411-1418. doi: 10.1016/j.dld.2025.04.036. Epub 2025 May 15.
Nakase H, Danese S, Reinisch W, Ritter T, Liang Y, Wendt E, Levesque BG, Yoon OK, Tian Y, Zhuo L, Karouzakis E, Bauer Y, Oortwijn A, Kaise T, Malkov VA, Hibi T. Mediators of Filgotinib Treatment Effects in Ulcerative Colitis: Exploring Circulating Biomarkers in the Phase 2b/3 SELECTION Study. Inflamm Bowel Dis. 2025 Apr 10;31(4):1095-1108. doi: 10.1093/ibd/izae278.
Schreiber S, Feagan BG, Louis E, Hisamatsu T, Hibi T, Dron L, Jamoul C, Patel H, Harris K, Taliadouros V, Oortwijn A, Peyrin-Biroulet L. Distinct trajectories of symptomatic response in ulcerative colitis during filgotinib therapy: A post hoc analysis from the SELECTION study. United European Gastroenterol J. 2024 Nov;12(9):1243-1255. doi: 10.1002/ueg2.12686. Epub 2024 Oct 25.
Watanabe K, Peyrin-Biroulet L, Danese S, Fujitani Y, Faes M, Oortwijn A, Lindsay JO, Rogler G, Hibi T. Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study. J Crohns Colitis. 2024 Jun 3;18(6):801-811. doi: 10.1093/ecco-jcc/jjad201.
Schreiber S, Rogler G, Watanabe M, Vermeire S, Maaser C, Danese S, Faes M, Van Hoek P, Hsieh J, Moerch U, Zhou Y, de Haas A, Rudolph C, Oortwijn A, Loftus EV Jr. Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674. Epub 2023 Sep 18.
Vermeire S, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Faes M, de Haas A, Rogler G. Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies. J Crohns Colitis. 2024 Jan 27;18(1):54-64. doi: 10.1093/ecco-jcc/jjad123.
Lu X, Zhou ZY, Xin Y, Wang MJ, Gray E, Jairath V, Lindsay JO. Matching-Adjusted Indirect Comparisons of Filgotinib vs Vedolizumab, Tofacitinib, and Ustekinumab for Moderately to Severely Active Ulcerative Colitis. Inflamm Bowel Dis. 2024 Jan 5;30(1):64-77. doi: 10.1093/ibd/izad037.
Dotan I, Feagan BG, Taliadouros V, Oortwijn A, Rudolph C, de Haas A, Santermans E, Hsieh J, Peyrin-Biroulet L, Hibi T. Efficacy of Filgotinib in Patients with Ulcerative Colitis by Line of Therapy in the Phase 2b/3 SELECTION Trial. J Crohns Colitis. 2023 Aug 21;17(8):1207-1216. doi: 10.1093/ecco-jcc/jjad039.
Schreiber S, Feagan BG, Peyrin-Biroulet L, Vermeire S, Faes M, Harris K, Oortwijn A, Daniele P, Patel H, Danese S. Filgotinib Improved Health-Related Quality of Life and Led to Comprehensive Disease Control in Individuals with Ulcerative Colitis: Data from the SELECTION Trial. J Crohns Colitis. 2023 Jun 16;17(6):863-875. doi: 10.1093/ecco-jcc/jjad018.
Loftus EV, Vermeire S, Feagan BG, Le Brun FO, Oortwijn A, Moerch U, Sandborn WJ, Hibi T. Corticosteroid-Sparing Effects of Filgotinib in Moderately to Severely Active Ulcerative Colitis: Data from the Phase 2b/3 SELECTION Study. J Crohns Colitis. 2023 Mar 18;17(2):211-220. doi: 10.1093/ecco-jcc/jjac122.
Feagan BG, Danese S, Loftus EV Jr, Vermeire S, Schreiber S, Ritter T, Fogel R, Mehta R, Nijhawan S, Kempinski R, Filip R, Hospodarskyy I, Seidler U, Seibold F, Beales ILP, Kim HJ, McNally J, Yun C, Zhao S, Liu X, Hsueh CH, Tasset C, Besuyen R, Watanabe M, Sandborn WJ, Rogler G, Hibi T, Peyrin-Biroulet L. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet. 2021 Jun 19;397(10292):2372-2384. doi: 10.1016/S0140-6736(21)00666-8. Epub 2021 Jun 3.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
FG002
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
FG003
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
FG004
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
FG005
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
FG006
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
FG007
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
FG008
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
FG009
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
FG010
Maintenance Study: Placebo From Induction Placebo
Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
FG000245 subjects
FG001278 subjects
FG002137 subjects
FG003262 subjects
FG004286 subjects
FG005143 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG000235 subjects
FG001256 subjects
FG002127 subjects
FG003234 subjects
FG004262 subjects
FG005127 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG00010 subjects
FG00122 subjects
FG00210 subjects
FG00328 subjects
FG00424 subjects
FG00516 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0016 subjects
FG0024 subjects
FG00318 subjects
FG00414 subjects
FG00510 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrew Consent
FG0004 subjects
FG00111 subjects
FG0024 subjects
FG0036 subjects
FG004
Protocol Violation
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Investigator's Discretion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-compliance With Study Drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Did not Receive Study Drug
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Study: Week 11 to Week 58
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
FG0010 subjectsParticipants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
FG0020 subjectsParticipants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
FG0030 subjects
FG0040 subjects
FG0050 subjectsParticipants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
FG006202 subjectsParticipants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
FG00799 subjectsParticipants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
FG008179 subjectsParticipants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
FG00991 subjectsParticipants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
FG01093 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol-specified Disease Worsening
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety Analysis Set for the Induction Study (Cohorts A and B) included all participants who took at least 1 dose of study drug in the Induction Study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
BG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
BG002
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
BG003
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
BG004
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
BG005
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000245
BG001277
BG002137
BG003262
BG004285
BG005142
BG0061348
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000122
BG001120
BG002
Race/Ethnicity, Customized
Not Permitted = local regulators did not allow collection of race or ethnicity information.
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
Race/Ethnicity, Customized
Not Permitted = local regulators did not allow collection of race or ethnicity information.
Count of Participants
Participants
No
Title
Denominators
Categories
Ethnicity
Title
Measurements
Not Hispanic or Latino
BG000238
BG001269
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Poland
Title
Measurements
BG00057
BG00156
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Full Analysis Set for the Induction study (Cohorts A and B) included all randomized participants who took at least 1 dose of study drug in the corresponding Induction study.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG002
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG004
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG005
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG000245
OG001277
OG002137
OG003
Title
Denominators
Categories
Title
Measurements
OG00026.1(20.4 to 31.8)
OG00119.1(14.3 to 23.9)
OG00215.3(8.9 to 21.7)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel(CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and immunomodulators (Yes/No) at Day 1.
0.0157
Difference in Percentages
10.8
2-Sided
95
2.1
19.5
Superiority
OG001
OG002
Primary
Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Full Analysis Set for the Maintenance Study included all participants randomized to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Study (Cohorts A and B) who achieved EBS remission or MCS response at Week 10, were rerandomized, and took at least 1 dose of study drug in the Maintenance Study.
Posted
Number
95% Confidence Interval
percentage of participants
Week 58
ID
Title
Description
OG000
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
OG001
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Secondary
Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10
MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Secondary
Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10
Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG002
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 200 mg
Secondary
Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10
Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Participants in the Full Analysis Set for the Induction study (Cohorts A and B) were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Secondary
Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10
MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Secondary
Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845
Cmax is defined as the maximum observed concentration of drug.
PK Substudy Analysis Set included all randomized participants who took at least 1 dose of filgotinib, participated in the PK substudy, and had at least 1 nonmissing intensive concentration value for filgotinib and/or GS-829845 with available data were analyzed.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG002
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Secondary
Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845
Tmax is defined as the time to reach maximum observed concentration of drug.
Participants in the PK Substudy Analysis Set with available data were analyzed.
Posted
Median
Full Range
hour (h)
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG002
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 100 mg
Secondary
Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Participants in the PK Substudy Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
hour*nanograms per milliliter (h*ng/mL)
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG002
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 100 mg
Secondary
Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Participants in the PK Substudy Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
h*ng/mL
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG002
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 100 mg
Secondary
Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Participants in the PK Substudy Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
ng/mL
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
ID
Title
Description
OG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG002
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 100 mg
Secondary
Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58
MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 58
ID
Title
Description
OG000
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
OG001
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Secondary
Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58
Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58.
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 58
ID
Title
Description
OG000
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
OG001
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
OG002
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Secondary
Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58
Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58.
Participants in the Full Analysis Set who were on corticosteroids at Maintenance Study baseline were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 58
ID
Title
Description
OG000
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
OG001
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
OG002
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Secondary
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58
Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 58
ID
Title
Description
OG000
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
OG001
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
OG002
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Secondary
Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58
Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 58
ID
Title
Description
OG000
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Secondary
Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58
MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 58
ID
Title
Description
OG000
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
OG001
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Secondary
Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845
Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845.
PK Analysis Set included all participants in the Safety Analysis Set who who took at least 1 dose of filgotinib and had at least 1 nonmissing plasma concentration value for filgotinib and/or its metabolite GS-829845 with available data were analyzed. Data was not collected for the Maintenance Study Placebo arms.
Posted
Median
Inter-Quartile Range
ng/mL
Week 26 (any Time) and Week 58 (predose)
ID
Title
Description
OG000
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
OG001
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Time Frame
Induction Study: first dose date up to one day before the Maintenance first dose date or last dose date whichever is earlier (maximum 17 weeks) plus 30 days, Maintenance study: First dose to the last dose in the Maintenance Study (maximum 51 weeks) plus 30 days
Description
Adverse Events: Safety Analysis Set for the study included all participants who took at least 1 dose of study drug in either the Induction Study (Cohorts A and B) or the Maintenance Study. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized on Day 1 into each corresponding study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
0
245
3
245
40
245
EG001
Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
0
278
13
277
43
277
EG002
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
0
137
4
137
20
137
EG003
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
0
262
19
262
83
262
EG004
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
0
286
15
285
77
285
EG005
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
0
143
9
142
55
142
EG006
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
2
202
9
202
67
202
EG007
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
0
99
0
99
33
99
EG008
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
0
179
8
179
53
179
EG009
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
0
91
7
91
33
91
EG010
Maintenance Study: Placebo From Induction Placebo
Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
0
93
4
93
26
93
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0021 affected137 at risk
EG0031 affected262 at risk
EG0041 affected285 at risk
EG0050 affected142 at risk
EG0060 affected202 at risk
EG0070 affected99 at risk
EG0080 affected179 at risk
EG0090 affected91 at risk
EG0100 affected93 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Appendiceal mucocoele
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0013 affected277 at risk
EG0023 affected137 at risk
EG003
Dental cyst
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Supernumerary teeth
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Type I hypersensitivity
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Acute hepatitis B
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0021 affected137 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Dengue fever
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0021 affected137 at risk
EG003
Paronychia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Procedural intestinal perforation
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0021 affected137 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Ovarian cyst ruptured
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Haemorrhagic infarction
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0010 affected277 at risk
EG0020 affected137 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0011 affected277 at risk
EG0020 affected137 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0006 affected245 at risk
EG00110 affected277 at risk
EG0024 affected137 at risk
EG00312 affected262 at risk
EG00411 affected285 at risk
EG00510 affected142 at risk
EG0064 affected202 at risk
EG0070 affected99 at risk
EG0084 affected179 at risk
EG0091 affected91 at risk
EG0100 affected93 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected245 at risk
EG0013 affected277 at risk
EG0023 affected137 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0006 affected245 at risk
EG0013 affected277 at risk
EG0025 affected137 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0008 affected245 at risk
EG0013 affected277 at risk
EG0021 affected137 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0005 affected245 at risk
EG0011 affected277 at risk
EG0021 affected137 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0007 affected245 at risk
EG0019 affected277 at risk
EG0022 affected137 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 affected245 at risk
EG0012 affected277 at risk
EG0020 affected137 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected245 at risk
EG0014 affected277 at risk
EG0022 affected137 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG00011 affected245 at risk
EG00112 affected277 at risk
EG0026 affected137 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
0.3379
Difference in Percentages
3.8
2-Sided
95
-4.3
12.0
Superiority
OG003
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.0103
Difference in Percentages
7.2
2-Sided
95
1.6
12.8
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.0645
Difference in Percentages
5.2
2-Sided
95
-0.0
10.5
Superiority
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
OG002
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
OG003
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Units
Counts
Participants
OG000199
OG00198
OG002172
OG00389
Title
Denominators
Categories
Title
Measurements
OG00037.2(30.2 to 44.2)
OG00111.2(4.5 to 18.0)
OG00223.8(17.2 to 30.5)
OG00313.5(5.8 to 21.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
< 0.0001
Difference in Percentages
26.0
2-Sided
95
16.0
35.9
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.0420
Difference in Percentages
10.4
2-Sided
95
-0.0
20.7
Superiority
OG002
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG004
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG005
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG000245
OG001277
OG002137
OG003262
OG004285
OG005142
Title
Denominators
Categories
Title
Measurements
OG00024.5(18.9 to 30.1)
OG00117.0(12.4 to 21.6)
OG00212.4(6.5 to 18.3)
OG0039.5(5.8 to 13.3)
OG0046.0(3.0 to 8.9)
OG0054.2(0.6 to 7.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
0.0053
Difference in Percentages
12.1
2-Sided
95
3.8
20.4
Superiority
OG001
OG002
Cochran-Mantel-Haenszel
CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
0.2295
Difference in Percentages
4.6
2-Sided
95
-3.1
12.2
Superiority
OG003
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.0393
Difference in Percentages
5.3
2-Sided
95
-0.1
10.7
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.5308
Difference in Percentages
1.7
2-Sided
95
-3.1
6.6
Superiority
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG004
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG005
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG000245
OG001277
OG002137
OG003262
OG004285
OG005142
Title
Denominators
Categories
Title
Measurements
OG00012.2(7.9 to 16.6)
OG0015.8(2.8 to 8.7)
OG0023.6(0.1 to 7.2)
OG0033.4(1.0 to 5.8)
OG0042.1(0.3 to 3.9)
OG0052.1(0.0 to 4.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
0.0047
Difference in Percentages
8.6
2-Sided
95
2.9
14.3
Superiority
OG001
OG002
Cochran-Mantel-Haenszel
CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
0.3495
Difference in Percentages
2.1
2-Sided
95
-2.6
6.8
Superiority
OG003
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.4269
Difference in Percentages
1.3
2-Sided
95
-2.5
5.1
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.9987
Difference in Percentages
-0.0
2-Sided
95
-3.4
3.4
Superiority
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG002
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG004
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG005
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG000245
OG001277
OG002137
OG003262
OG004285
OG005142
Title
Denominators
Categories
Title
Measurements
OG00035.1(28.9 to 41.3)
OG00123.8(18.6 to 29.0)
OG00216.1(9.5 to 22.6)
OG00319.8(14.8 to 24.9)
OG00413.7(9.5 to 17.8)
OG0058.5(3.5 to 13.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
<0.0001
Difference in Percentages
19.0
2-Sided
95
9.9
28.2
Superiority
OG001
OG002
Cochran-Mantel-Haenszel
CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
0.0672
Difference in Percentages
7.8
2-Sided
95
-0.7
16.2
Superiority
OG003
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.0019
Difference in Percentages
11.4
2-Sided
95
4.2
18.6
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.1286
Difference in Percentages
5.2
2-Sided
95
-1.4
11.8
Superiority
OG002
Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG003
Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
OG004
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
OG005
Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG000245
OG001277
OG002137
OG003262
OG004285
OG005142
Title
Denominators
Categories
Title
Measurements
OG00012.2(7.9 to 16.6)
OG0018.7(5.2 to 12.2)
OG0024.4(0.6 to 8.2)
OG0033.8(1.3 to 6.3)
OG0042.1(0.3 to 3.9)
OG0052.1(0.0 to 4.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1
0.0105
Difference in Percentages
7.9
2-Sided
95
1.9
13.8
Superiority
OG001
OG002
Cochran-Mantel-Haenszel
CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1
0.1062
Difference in Percentages
4.3
2-Sided
95
-1.0
9.6
Superiority
OG003
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.3084
Difference in Percentages
1.7
2-Sided
95
-2.2
5.6
Superiority
OG004
OG005
Cochran-Mantel-Haenszel
CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
0.9109
Difference in Percentages
-0.0
2-Sided
95
-3.4
3.4
Superiority
OG003
Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG0004
OG00111
OG0029
OG00317
Title
Denominators
Categories
Filgotinib
ParticipantsOG0004
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG00317
Title
Measurements
OG0001746.3± 1244.05
OG001725.1± 313.36
OG0022283.3± 1012.03
OG003
Metabolite GS-829845
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0029
ParticipantsOG00317
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG0004
OG00111
OG0029
OG00317
Title
Denominators
Categories
Filgotinib
ParticipantsOG0004
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG00317
Title
Measurements
OG0001.50(0.75 to 2.00)
OG0010.75(0.50 to 3.00)
OG0021.00(0.50 to 2.25)
OG003
Metabolite GS-829845
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0029
ParticipantsOG00317
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG0004
OG00111
OG0029
OG00317
Title
Denominators
Categories
Filgotinib
ParticipantsOG0004
ParticipantsOG00110
ParticipantsOG0028
ParticipantsOG00315
Title
Measurements
OG0005501.3± 1956.39
OG0011909.3± 788.13
OG0026475.6± 1643.00
OG003
Metabolite GS-829845
ParticipantsOG0004
ParticipantsOG00110
ParticipantsOG0027
ParticipantsOG00315
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG0004
OG00111
OG0029
OG00317
Title
Denominators
Categories
Filgotinib
ParticipantsOG0004
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG00317
Title
Measurements
OG0005537.3± 1900.93
OG0011881.9± 797.51
OG0026743.1± 1743.68
OG003
Metabolite GS-829845
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0029
ParticipantsOG00317
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Units
Counts
Participants
OG0004
OG00111
OG0029
OG00317
Title
Denominators
Categories
Filgotinib
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG00313
Title
Measurements
OG00012.0± 4.74
OG0014.5± 3.61
OG00236.6± 79.06
OG003
Metabolite GS-829845
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG0028
ParticipantsOG00315
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
OG002
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm) who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
OG003
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Units
Counts
Participants
OG000199
OG00198
OG002172
OG00389
Title
Denominators
Categories
Title
Measurements
OG00034.7(27.8 to 41.5)
OG0019.2(3.0 to 15.4)
OG00222.7(16.1 to 29.2)
OG00313.5(5.8 to 21.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
<0.0001
Difference in Percentages
25.5
2-Sided
95
16.0
35.0
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.0658
Difference in Percentages
9.2
2-Sided
95
-1.1
19.5
Superiority
OG003
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Units
Counts
Participants
OG000199
OG00198
OG002172
OG00389
Title
Denominators
Categories
Title
Measurements
OG00018.1(12.5 to 23.7)
OG0015.1(0.2 to 10.0)
OG0028.7(4.2 to 13.2)
OG0037.9(1.7 to 14.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.0024
Difference in Percentages
13.0
2-Sided
95
5.3
20.6
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.7951
Difference in Percentages
0.9
2-Sided
95
-7.0
8.7
Superiority
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
OG003
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Units
Counts
Participants
OG00092
OG00147
OG00281
OG00337
Title
Denominators
Categories
Title
Measurements
OG00027.2(17.5 to 36.8)
OG0016.4(0.0 to 14.4)
OG00213.6(5.5 to 21.7)
OG0035.4(0.0 to 14.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.0055
Difference in Percentages
20.8
2-Sided
95
7.7
33.9
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.1265
Difference in Percentages
8.2
2-Sided
95
-4.2
20.6
Superiority
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
OG003
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Units
Counts
Participants
OG000199
OG00198
OG002172
OG00389
Title
Denominators
Categories
Title
Measurements
OG00015.6(10.3 to 20.9)
OG0016.1(0.9 to 11.4)
OG00213.4(8.0 to 18.7)
OG0037.9(1.7 to 14.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.0157
Difference in Percentages
9.5
2-Sided
95
1.8
17.1
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.1808
Difference in Percentages
5.5
2-Sided
95
-2.9
13.9
Superiority
OG001
Maintenance Study: Placebo From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
OG002
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
OG003
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Units
Counts
Participants
OG000199
OG00198
OG002172
OG00389
Title
Denominators
Categories
Title
Measurements
OG00038.2(31.2 to 45.2)
OG00113.3(6.0 to 20.5)
OG00227.9(20.9 to 34.9)
OG00318.0(9.4 to 26.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
<0.0001
Difference in Percentages
24.9
2-Sided
95
14.6
35.2
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.0521
Difference in Percentages
9.9
2-Sided
95
-1.3
21.2
Superiority
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
OG002
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
OG003
Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Units
Counts
Participants
OG000199
OG00198
OG002172
OG00389
Title
Denominators
Categories
Title
Measurements
OG00022.1(16.1 to 28.1)
OG0016.1(0.9 to 11.4)
OG00212.2(7.0 to 17.4)
OG0037.9(1.7 to 14.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.0005
Difference in Percentages
16.0
2-Sided
95
7.8
24.2
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
0.2946
Difference in Percentages
4.3
2-Sided
95
-3.9
12.6
Superiority
Units
Counts
Participants
OG000173
OG001136
Title
Denominators
Categories
Filgotinib: Week 26
ParticipantsOG000169
ParticipantsOG001127
Title
Measurements
OG0008.5(5.0 to 25.8)
OG0014.4(2.5 to 14.0)
Filgotinib: Week 58
ParticipantsOG00044
ParticipantsOG00126
Title
Measurements
OG0003.9(NA to 9.1)Value was below the limit of quantitation.