Filgotinib in the Induction and Maintenance of Remission... | NCT02914561 | Trialant
NCT02914561
Sponsor
Lakefront Biotherapeutics NV
Status
Completed
Last Update Posted
Dec 18, 2023Actual
Enrollment
1,372Actual
Phase
Phase 3
Conditions
Crohn's Disease
Interventions
Filgotinib
Placebo
Countries
United States
Argentina
Australia
Austria
Belgium
Bulgaria
Canada
Croatia
Czechia
France
Georgia
Germany
Greece
Hong Kong
Hungary
Iceland
India
Ireland
Israel
Italy
Japan
Malaysia
Netherlands
New Zealand
Norway
Poland
Portugal
Romania
Russia
Serbia
Singapore
Slovakia
South Africa
South Korea
Spain
Sri Lanka
Sweden
Switzerland
Taiwan
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02914561
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-419-3895
Secondary IDs
ID
Type
Description
Link
2016-001367-36
EudraCT Number
Brief Title
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Official Title
Combined Phase 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 Crohn's Disease
Acronym
DIVERSITY1
Organization
Lakefront Biotherapeutics NVINDUSTRY
Status Module
Record Verification Date
Nov 2023
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
Oct 31, 2016Actual
Primary Completion Date
Nov 11, 2022Actual
Completion Date
Nov 11, 2022Actual
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
Oct 23, 2023
Results First Submitted that Met QC Criteria
Nov 24, 2023
Results First Posted Date
Dec 18, 2023Actual
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
Nov 24, 2023
Last Update Posted Date
Dec 18, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Lakefront Biotherapeutics NVINDUSTRY
Collaborators
Name
Class
Gilead Sciences
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 safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.
Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).
Detailed Description
Not provided
Conditions Module
Conditions
Crohn's Disease
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
1,372Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A: Filgotinib 200 (mg) (Induction Study)
Experimental
Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Other: Placebo
Cohort A: Filgotinib 100 mg (Induction Study)
Experimental
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Other: Placebo
Cohort A: Placebo (Induction Study)
Placebo Comparator
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Other: Placebo
Cohort B: Filgotinib 200 mg (Induction Study)
Experimental
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Other: Placebo
Cohort B: Filgotinib 100 mg (Induction Study)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Filgotinib
Drug
Filgotinib tablets administered orally once daily.
Cohort A: Filgotinib 100 mg (Induction Study)
Cohort A: Filgotinib 200 (mg) (Induction Study)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Clinical remission was defined as a CDAI of < 150 points.
Week 10
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
Week 10
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Clinical remission was defined as a CDAI of < 150 points.
Secondary Outcomes
Measure
Description
Time Frame
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
Moderately to severely active CD
Cohort A (Biologic Naïve): 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 and immunomodulators
Cohort A (Biologic Experienced): 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) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
Cohort B (Biologic Experienced): 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): TNFa antagonists, vedolizumab, and ustekinumab
Key Exclusion Criteria:
Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
Active tuberculosis (TB) or history of latent TB that has not been treated
Use of any prohibited concomitant medications as described in the study protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Vermeire S, Schreiber S, Rubin DT, D'Haens G, Reinisch W, Watanabe M, Mehta R, Roblin X, Beales I, Gietka P, Hibi T, Hospodarskyy I, Ritter T, Genovese MC, Kwon P, Santermans E, Le Brun FO, Barron R, Masior T, Danese S. Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Feb;10(2):138-153. doi: 10.1016/S2468-1253(24)00272-3. Epub 2024 Dec 2.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants who met protocol eligibility criteria were assigned to the respective Cohort and subsequently randomized in a blinded fashion in a 1:1:1 ratio to 1 of 3 treatments: filgotinib 200 milligram (mg), filgotinib 100 mg and placebo.
Recruitment Details
Participants with diagnosis of moderately to severely Active Crohn's disease (CD) were enrolled in the study. Participants who were biologic-naïve or biologic-experienced were enrolled in Cohort A and participants who were biologic-experienced were enrolled in Cohort B, respectively.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
FG001
Cohort A: Filgotinib 100 mg (Induction Study)
Periods
Title
Milestones
Reasons Not Completed
Induction Study (Day 1 to Week 10)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2.0
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
Dec 2, 2021
Oct 18, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Mexico
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
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Other: Placebo
Cohort B: Placebo (Induction Study)
Placebo Comparator
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Other: Placebo
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Experimental
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Drug: Filgotinib
Filgotinib 200 mg to Placebo (Maintenance Study)
Experimental
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Drug: Filgotinib
Other: Placebo
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Experimental
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Drug: Filgotinib
Filgotinib 100 mg to Placebo (Maintenance Study)
Experimental
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Drug: Filgotinib
Other: Placebo
Placebo to Placebo (Maintenance Study)
Placebo Comparator
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Other: Placebo
Cohort A: Placebo (Induction Study)
Cohort B: Filgotinib 100 mg (Induction Study)
Cohort B: Filgotinib 200 mg (Induction Study)
Cohort B: Placebo (Induction Study)
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Filgotinib 100 mg to Placebo (Maintenance Study)
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Filgotinib 200 mg to Placebo (Maintenance Study)
GS-6034
GLPG0634
Placebo
Other
Placebo administered orally once daily.
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 (Induction Study)
Filgotinib 100 mg to Placebo (Maintenance Study)
Filgotinib 200 mg to Placebo (Maintenance Study)
Placebo to Placebo (Maintenance Study)
Week 58
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
Week 58
Week 10
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score < 150 points.
Week 10
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score < 150 points.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Sustained Clinical Remission by CDAI: CDAI <150 combined at both Week 10 and Week 58.
Weeks 10 and 58
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI <150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.
Sustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.
Weeks 10 and 58
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.
6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.
Week 58
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
Plasma concentrations of filgotinib [nanogram/milliliters (ng/mL)].
Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
Plasma concentrations of filgotinib (ng/mL).
Week 10: Predose
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
Plasma concentrations of filgotinib (ng/mL).
Week 26: At any timepoint
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
Plasma concentrations of filgotinib (ng/mL).
Week 58: Pre-dose
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
Plasma concentrations of GS-829845 (ng/mL).
Week 4: 0.5, 1, 2, and 3 hrs post dose
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10
Plasma concentrations of GS-829845 (ng/mL).
Week 10: Predose
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
Plasma concentrations of GS-829845 (ng/mL).
Week 26: At any timepoint
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
Plasma concentrations of GS-829845 (ng/mL).
Week 58: Pre-dose
Sun City
Arizona
85351
United States
Southern California Research Center, Inc.
Coronado
California
92118
United States
VVCRD Research
Garden Grove
California
92845
United States
UC San Diego Health System
La Jolla
California
92037
United States
Cedars Sinai Medical Center
Los Angeles
California
90048
United States
Inland Empire Clinical Trials, LLC
Rialto
California
92377
United States
Kaiser Permanente
San Francisco
California
94118
United States
Clearview Medical Research, LLC
Santa Clarita
California
91351
United States
University of Colorado Denver and Hospital
Aurora
Colorado
80045
United States
South Denver Gastroenterology, PC
Lone Tree
Colorado
80124
United States
Connecticut GI, PC-Research Division
Farmington
Connecticut
06032
United States
Medstar Georgetown University Hospital (Patient Exams)
Washington D.C.
District of Columbia
20007
United States
Advanced Research, LLC
Coral Springs
Florida
33067
United States
UF Clinical Research Center
Gainesville
Florida
32610
United States
Florida Research Institute
Lakewood Rch
Florida
34211
United States
Florida Center for Gastroenterology
Largo
Florida
33777
United States
University of Miami Crohn's and Colitis Center
Miami
Florida
33136
United States
Advanced Pharma CR
Miami
Florida
33147
United States
Cordova Research Institute
Miami
Florida
33155
United States
Vista Health Research, LLC
Miami
Florida
33176
United States
Gastroenterology Group of Naples
Naples
Florida
34102
United States
Center for Interventional Endoscopy - AdventHealth Orlando
Orlando
Florida
32803
United States
Gulf Region Clinical Research Institute
Pensacola
Florida
32514
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
Illinois Gastroenterology Group - Arlington Heights
Arlington Heights
Illinois
60005
United States
Northwestern University, Feinberg School of Medicine
Chicago
Illinois
60611
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
Illinois Gastroenterology Group - Gurnee
Gurnee
Illinois
60031
United States
Indiana University Health University Hospital
Indianapolis
Indiana
46202
United States
University of Iowa Hospitals and Clinics
Iowa City
Iowa
52242
United States
University of Kansas Medical Center
Kansas City
Kansas
66160
United States
University of Louisville, School of Medicine
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
University of Maryland Medical Center
Baltimore
Maryland
21201
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
Spectrum Health Butterworth Hospital
Grand Rapids
Michigan
49546
United States
Mayo Clinic
Rochester
Minnesota
55902
United States
University of Mississippi Medical Center
Jackson
Mississippi
39216
United States
Kansas City Research Institute
Kansas City
Missouri
64131
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Las Vegas Medical Research
Las Vegas
Nevada
89113
United States
AGA Clinical Research Associates, LLC
Egg Harbor
New Jersey
08234
United States
NY Scientific
Brooklyn
New York
11235
United States
NYU Langone Long Island Clinical Research Associates
Great Neck
New York
11021
United States
New York University School of Medicine/NYU Gastroenterology Associates
New York
New York
10016
United States
Lenox Hill Hospital
New York
New York
10028
United States
Premier Medical Group of the Hudson Valley
Poughkeepsie
New York
12601
United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte
North Carolina
28207
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
Paramount Medical Research & Consulting, LLC
Middleburg Heights
Ohio
44130
United States
Options Health Research LLC
Tulsa
Oklahoma
74104
United States
Great Lakes Medical Research, LLC
Harrisburg
Pennsylvania
17110
United States
Gastroenterology Associates of Orangeburg
Orangeburg
South Carolina
29118
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
United States
Texas Clinical Research Institute
Arlington
Texas
76012
United States
Pinnacle Clinical Research
Austin
Texas
78757
United States
Inquest Clinical Research
Baytown
Texas
77521
United States
San Antonio Military Medical Center
Fort Sam Houston
Texas
78219
United States
DHAT Research Institute
Garland
Texas
75044
United States
Kelsey-Seybold Clinic
Houston
Texas
77025
United States
Baylor College of Medicine- Baylor Medical Center
Houston
Texas
77030
United States
The Methodist Hospital
Houston
Texas
77030
United States
The University of Texas Health Science Center at Houston
Houston
Texas
77030
United States
Centex Studies, Inc.
Houston
Texas
77058
United States
Gulf Coast Research Group
Houston
Texas
77098
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
Pinnacle Clinical Research
San Antonio
Texas
78229
United States
TDDC San Marcos
San Marcos
Texas
78666
United States
Texas Digestive Disease Consultants (IP Shipment)
Southlake
Texas
76092
United States
Spring Gastroenterology
The Woodlands
Texas
77380
United States
Tyler Research Institute, LLC
Tyler
Texas
75701
United States
HP Clinical Research
Bountiful
Utah
84010
United States
University of Virginia Health System
Charlottesville
Virginia
22908
United States
Charlottesville Medical Research Center, LLC
Charlottesville
Virginia
22911
United States
Gastroenterology Associates of Tidewater
Chesapeake
Virginia
23320
United States
Emeritas Research Group LLC
Leesburg
Virginia
20176
United States
McGuire DVAMC, GI (111N)
Richmond
Virginia
23249
United States
Virginia Commonwealth University
Richmond
Virginia
23298
United States
University of Wisconsin Hospital & Clinics
Madison
Wisconsin
53792
United States
Wisconsin Center for Advanced Research, a division of GI Associates, LLC
Milwaukee
Wisconsin
53215
United States
Fundacion Estudios Clinicos CiRec
Rosario
S2000DEF
Argentina
Royal Prince Alfred Hospital
Camperdown
New South Wales
2050
Australia
Monash Medical Centre
Clayton
New South Wales
3168
Australia
St. Vincent's Hospital Sydney
Darlinghurst
New South Wales
2010
Australia
Nepean Hospital
Kingswood
New South Wales
2747
Australia
Wollongong Hospital
Wollongong
New South Wales
2500
Australia
Coastal Digestive Health
Mountain Creek
Queensland
4557
Australia
Coral Sea Clinical Research Institute (Mackay)
North Mackay
Queensland
4740
Australia
Mater Misericordiae Ltd
South Brisbane
Queensland
4101
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
4102
Australia
Flinders Medical Centre
Bedford Park
South Australia
5042
Australia
The Queen Elizabeth Hospital
Woodville South
South Australia
5011
Australia
Emeritus Research
Camberwell
Victoria
3124
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
Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
Universitatsklinik Innsbruck
Innsbruck
6020
Austria
AKH-Medizinische Universitat Wien
Vienna
1090
Austria
GZA Ziekenhuizen campus Sint-Vincentius
Antwerp
2018
Belgium
Imelda General Hospital
Bonheiden
2820
Belgium
CUB Hopital Erasme
Brussels
1070
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
Universitair Ziekenhuis Leuven
Leuven
3000
Belgium
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège
4000
Belgium
CHR Citadelle
Liège
4000
Belgium
AZ Delta Campus Wilgenstraat
Roeselare
8800
Belgium
Medical Center - Complete Medical Solutions OOD
Samokov
2000
Bulgaria
Medical Center - "Tsaritsa Yoanna" EOOD
Sliven
8800
Bulgaria
"MDHAT Dr. St.Cherkezov" AD
Veliko Tarnovo
5000
Bulgaria
MHAT "Sveta Petka" AD
Vidin
3700
Bulgaria
Barrie GI Associates
Barrie
L4M 7G1
Canada
University of Calgary, Heritage Medical Research Clinic
Calgary
T2N 4Z6
Canada
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton
L8S 4K1
Canada
London Health Sciences Centre - University Hospital
Centro Hospitalar e Universitario de Coimbra, E.P.E.
Coimbra
3000-075
Portugal
Centro Hospitalar Cova de Beira, EPE
Covilha
6200-251
Portugal
Centro Hospitalar do Algarve EPE
Faro
8000-386
Portugal
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimarães
4835-044
Portugal
Hospital Beatriz Angelo
Loures
2674-514
Portugal
Centro Hospitalar de Sao Joao, EPE
Porto
4200-319
Portugal
Unidade Local de Saude do Alto Minho, EPE
Viana do Castelo
4904-858
Portugal
SC MedLife SA, Gastroenterologie
Bucharest
010719
Romania
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie
Bucharest
010825
Romania
S.C. Centrul Medical Sana S.R.L., Gastroenterologie
Bucharest
011025
Romania
Delta Health Care/ Ponderas Academic Hospital
Bucharest
014142
Romania
Spitalul Clinic Colentina, Gastroenterologie
Bucharest
020125
Romania
MedLife, Gastroenterologie
Bucharest
031784
Romania
Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II
Bucharest
050098
Romania
Gastromedica SRL, Gastroenterologie
Iași
700506
Romania
Cabinet Particular Policlinic Algomed SRL
Timișoara
300002
Romania
Centrul Medical Tuculanu, Gastroenterologie
Timișoara
300168
Romania
S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie
Timișoara
300594
Romania
State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk
454076
Russia
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
Irkutsk
669079
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 Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk
630087
Russia
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk
630091
Russia
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
Saint Petersburg
191015
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
Clinical Center of Serbia
Belgrade
11000
Serbia
Clinical Hospital Center Zemun
Belgrade
11000
Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade
3010-777
Serbia
Zvezdara University Medical Center
Belgrade
3810-969
Serbia
Clinical Center of Vojvodina
Novi Sad
21000
Serbia
National University Hospital
Singapore
119074
Singapore
Singapore General Hospital
Singapore
169608
Singapore
Tan Tock Seng Hospital
Singapore
308433
Singapore
Changi General Hospital
Singapore
529889
Singapore
Cliniq s. r. o., Gastroenterologicke centrum Ruzinov
Bratislava
82007
Slovakia
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra
950 01
Slovakia
Gastro I., s.r.o.
Prešov
8001
Slovakia
Dr MJ Prins
Cape Town
7500
South Africa
Dr John P Wright
Cape Town
7708
South Africa
Peermed Clinical Trial Centre
Johannesburg
1619
South Africa
Pusan National University Hospital
Busan
49241
South Korea
Yeungnam University Hospital
Daegu
42415
South Korea
Kyung Hee University Hospital
Guri-si
471-701
South Korea
Hanyang University Guri Hospital
Gyeonggi-do
11923
South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si
13496
South Korea
Seoul National University Hospital
Seoul
03080
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
The Catholic University of Korea, St. Vincent's Hospital
Suwon
16247
South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju
220-701
South Korea
Hospital Universitari Germans Trias i Pujol
Badalona
08916
Spain
Centro Medico Teknon
Barcelona
08022
Spain
Hospital del Mar
Barcelona
8003
Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol
15405
Spain
Hospital Universitario de Gran Canaria "Dr. Negrin"
Las Palmas de Gran Canaria
35010
Spain
Hospital General Universitario Gregorio Maranon
Madrid
28007
Spain
Hospital Clinico San Carlos
Madrid
28040
Spain
Hospital Universitario de Fuenlabrada
Madrid
28942
Spain
Hospital Universitario Central de Asturias
Oviedo
33006
Spain
Complejo Hospitalario Universitario de Pontevedra
Pontevedra
36071
Spain
Hospital de Sagunto
Sagunto
46520
Spain
Hospital Universitario Virgen del Rocio
Seville
41013
Spain
Hospital de Galdakao-Usandolo
Usansolo
48960
Spain
National Hospital of Sri Lanka
Colombo
00700
Sri Lanka
Teaching hospital Karapitiya
Galle
80000
Sri Lanka
Kandy Teaching Hospital
Kandy
20000
Sri Lanka
Colombo North Teaching Hospital
Ragama
11010
Sri Lanka
Danderyds Sjukhus AB
Danderyd
SE-18288
Sweden
Akademiska Sjukhuset
Uppsala
75185
Sweden
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern
3012
Switzerland
Universitatsspital Zurich
Zurich
8091
Switzerland
Changhua Christian Hospital
Changhua
500
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
807
Taiwan
Far Eastern Memorial Hospital
New Taipei City
220
Taiwan
Chang Shan Medical University Hospital
Taichung
40201
Taiwan
China Medical University Hospital
Taichung
40447
Taiwan
National Cheng Kung University Hospital
Tainan
7428
Taiwan
National Taiwan University Hospital
Taipei
100
Taiwan
Mackay Memorial Hospital, Taipei
Taipei
104
Taiwan
Taipei Veterans General Hospital
Taipei
112
Taiwan
Tri-Service General Hospital
Taipei
114
Taiwan
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan
33305
Taiwan
Bukovinian State Medical University
Chernivtsi
58000
Ukraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
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
76018
Ukraine
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
Kharkiv
61037
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
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
Municipal Institution "Uzhgorod District Hospital", Therapy Department
Uzhhorod
88009
Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia
21005
Ukraine
Medical Center LLC "Health Clinic"
Vinnytsia
21009
Ukraine
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia
21018
Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya
69600
Ukraine
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
Norfolk
NR4 7UY
United Kingdom
Queen Elizabeth Hospital
Birmingham
B15 2WB
United Kingdom
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
Medical Outpatient Department
Exeter
EX2 5DW
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
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
London
W2 1NY
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
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
FG002
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
FG003
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
FG004
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
FG005
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
FG006
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
FG007
Filgotinib 200 mg to Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
FG008
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
FG009
Filgotinib 100 mg to Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
FG010
Placebo to Placebo (Maintenance Study)
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
FG000223 subjects
FG001245 subjects
FG002239 subjects
FG003204 subjects
FG004230 subjects
FG005231 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Treated
FG000222 subjects
FG001245 subjects
FG002237 subjects
FG003202 subjects
FG004228 subjects
FG005229 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG000204 subjects
FG001213 subjects
FG002212 subjects
FG003177 subjects
FG004183 subjects
FG005192 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG00019 subjects
FG00132 subjects
FG00227 subjects
FG00327 subjects
FG00447 subjects
FG00539 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG00015 subjects
FG00114 subjects
FG00214 subjects
FG00324 subjects
FG00431 subjects
FG00519 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal by Subject
FG0001 subjects
FG0019 subjects
FG0026 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
FG004
Physician Decision
FG0001 subjects
FG0015 subjects
FG0022 subjects
FG0030 subjects
FG004
Non-Compliance with Study Drug
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Randomized but not treated
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Maintenance Study (Weeks 11 to 58)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG006118 subjectsNot all participants who completed the induction study entered the maintenance study.
FG00756 subjectsNot all participants who completed the induction study entered the maintenance study.
FG008105 subjectsNot all participants who completed the induction study entered the maintenance study.
FG00956 subjectsNot all participants who completed the induction study entered the maintenance study.
FG010146 subjectsNot all participants who completed the induction study entered the maintenance study.
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
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
The All Randomized Analysis Set included all participants who were randomized in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
BG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
BG002
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
BG003
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
BG004
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
BG005
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000223
BG001245
BG002239
BG003204
BG004230
BG005231
BG0061372
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
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000110
BG001106
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Hong Kong
Title
Measurements
BG0001
BG0010
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 Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Clinical remission was defined as a CDAI of < 150 points.
The Full Analysis Set (FAS) for each 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
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG002
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG003
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG004
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG005
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Units
Counts
Participants
OG000222
OG001245
OG002237
OG003
Title
Denominators
Categories
Title
Measurements
OG00032.9(26.5 to 39.3)
OG00125.7(20.0 to 31.4)
OG00219.8(14.5 to 25.1)
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 (CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, >=1).
Cochran-Mantel-Haenszel
0.0017
Stratified Percentage Difference
12.7
2-Sided
95
4.7
20.7
Superiority
OG001
OG002
Primary
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
FAS for induction study was analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Primary
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Clinical remission was defined as a CDAI of < 150 points.
The FAS for the Maintenance Study included all participants randomized to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Studies who were re-randomized in the Maintenance Study and took at least 1 dose of study drug in the Maintenance Study and achieved clinical remission by PRO2 or endoscopic response at Week 10.
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Primary
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Secondary
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
FAS for induction study was analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG002
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Secondary
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score < 150 points.
FAS for induction study was analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Secondary
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG002
Filgotinib 200 mg - Placebo (Maintenance Study)
Secondary
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score < 150 points.
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Sustained Clinical Remission by CDAI: CDAI <150 combined at both Week 10 and Week 58.
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Secondary
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI <150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.
The FAS for the Maintenance Study with available data was analyzed.
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.
Sustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG002
Secondary
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.
6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.
The FAS for the Maintenance Study with available data was analyzed.
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Secondary
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
Plasma concentrations of filgotinib [nanogram/milliliters (ng/mL)].
Pharmacokinetic (PK) Analysis Set (included all randomized participants who took at least 1 dose of filgotinib and had at least 1 non-missing concentration value for filgotinib and/or its metabolite GS-829845 reported by the PK laboratory) for Induction study was analyzed.
Posted
Mean
Standard Deviation
ng/mL
Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
ID
Title
Description
OG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG002
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Secondary
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
Plasma concentrations of filgotinib (ng/mL).
PK Analysis Set for Induction study was analyzed.
Posted
Mean
Standard Deviation
ng/mL
Week 10: Predose
ID
Title
Description
OG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG002
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG003
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Secondary
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
Plasma concentrations of filgotinib (ng/mL).
PK Analysis Set for Maintenance study was analyzed
Posted
Mean
Standard Deviation
ng/mL
Week 26: At any timepoint
ID
Title
Description
OG000
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
OG001
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
Secondary
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
Plasma concentrations of filgotinib (ng/mL).
PK Analysis Set for Maintenance study was analyzed
Posted
Mean
Standard Deviation
ng/mL
Week 58: Pre-dose
ID
Title
Description
OG000
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
OG001
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
Secondary
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
Plasma concentrations of GS-829845 (ng/mL).
PK Analysis Set for Induction study was analyzed.
Posted
Mean
Standard Deviation
ng/mL
Week 4: 0.5, 1, 2, and 3 hrs post dose
ID
Title
Description
OG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG002
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG003
Cohort B: Filgotinib 100 mg (Induction Study)
Secondary
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10
Plasma concentrations of GS-829845 (ng/mL).
PK Analysis Set for Induction study was analyzed.
Posted
Mean
Standard Deviation
ng/mL
Week 10: Predose
ID
Title
Description
OG000
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG002
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG003
Cohort B: Filgotinib 100 mg (Induction Study)
Secondary
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
Plasma concentrations of GS-829845 (ng/mL).
PK Analysis Set for Maintenance study was analyzed
Posted
Mean
Standard Deviation
ng/mL
Week 26: At any timepoint
ID
Title
Description
OG000
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
OG001
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
Secondary
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
Plasma concentrations of GS-829845 (ng/mL).
PK Analysis Set for Maintenance study was analyzed
Posted
Mean
Standard Deviation
ng/mL
Week 58: Pre-dose
ID
Title
Description
OG000
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
OG001
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
Time Frame
From first dose up to Week 62
Description
Safety Analysis Set
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
Cohort A: Filgotinib 200 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
0
222
18
222
87
222
EG001
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
0
245
16
245
90
245
EG002
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks..
0
237
15
237
90
237
EG003
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks
0
202
19
202
106
202
EG004
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
0
228
36
228
107
228
EG005
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
0
229
26
229
109
229
EG006
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
0
118
13
118
59
118
EG007
Filgotinib 200 mg to Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
0
56
5
56
28
56
EG008
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
0
104
14
104
59
104
EG009
Filgotinib 100 mg to Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
0
55
3
55
25
55
EG010
Placebo to Placebo (Maintenance Study)
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
0
145
14
145
77
145
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG0030 events0 affected202 at risk
EG0041 events1 affected228 at risk
EG0051 events1 affected229 at risk
EG0060 events0 affected118 at risk
EG0070 events0 affected56 at risk
EG0081 events1 affected104 at risk
EG0090 events0 affected55 at risk
EG0101 events1 affected145 at risk
Anaemia of chronic disease
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Influenza A virus test positive
Investigations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Autoimmune myocarditis
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Myelosuppression
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Intensive care unit acquired weakness
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Central serous chorioretinopathy
Eye disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Corneal scar
Eye disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0011 events1 affected245 at risk
EG0022 events1 affected237 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0007 events7 affected222 at risk
EG0019 events9 affected245 at risk
EG0028 events7 affected237 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Gastrointestinal wall thickening
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Ileal perforation
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Intestinal fistula
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0012 events2 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Intra-abdominal fluid collection
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Large intestinal stenosis
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0012 events2 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Megacolon
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Lower gastrointestinal hemorrhage
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Rectal ulcer hemorrhage
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Renal infarct
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Arthritis enteropathic
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Peripheral spondyloarthritis
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Primary adrenal insufficiency
Endocrine disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Abscess intestinal
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Bacteremia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Bartholinitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected237 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Colonic abscess
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Escherichia bacteremia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Epstein-Barr virus infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Peritoneal abscess
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Sepsis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Systemic candida
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Post procedural hemorrhage
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Procedural intestinal perforation
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Asthenia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Pyrexia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Depression
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Gastrointestinal fistula
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0018 events8 affected245 at risk
EG0027 events7 affected237 at risk
EG0037 events6 affected202 at risk
EG0048 events8 affected228 at risk
EG0052 events2 affected229 at risk
EG0063 events3 affected118 at risk
EG0073 events3 affected56 at risk
EG0083 events3 affected104 at risk
EG0091 events1 affected55 at risk
EG0105 events4 affected145 at risk
Weight decreased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0013 events3 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG0007 events5 affected222 at risk
EG0014 events4 affected245 at risk
EG0024 events4 affected237 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG00014 events13 affected222 at risk
EG00117 events16 affected245 at risk
EG00212 events12 affected237 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected222 at risk
EG0012 events2 affected245 at risk
EG0025 events4 affected237 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0010 events0 affected245 at risk
EG0023 events3 affected237 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG00016 events16 affected222 at risk
EG0016 events6 affected245 at risk
EG0028 events8 affected237 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0004 events4 affected222 at risk
EG0015 events5 affected245 at risk
EG0024 events4 affected237 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0005 events5 affected222 at risk
EG00115 events15 affected245 at risk
EG00216 events16 affected237 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected222 at risk
EG0012 events2 affected245 at risk
EG0023 events3 affected237 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0005 events5 affected222 at risk
EG0012 events2 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected222 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0014 events4 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG00011 events11 affected222 at risk
EG00110 events10 affected245 at risk
EG00211 events11 affected237 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0004 events4 affected222 at risk
EG0012 events2 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0012 events2 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0005 events5 affected222 at risk
EG0012 events2 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected222 at risk
EG0012 events2 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0006 events5 affected222 at risk
EG00112 events11 affected245 at risk
EG0027 events6 affected237 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected222 at risk
EG0017 events7 affected245 at risk
EG0028 events7 affected237 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0011 events1 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0017 events7 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0002 events1 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
MedDRA (25.0)
Systematic Assessment
EG0004 events3 affected222 at risk
EG0011 events1 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0012 events2 affected245 at risk
EG0024 events4 affected237 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0010 events0 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0012 events2 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0008 events7 affected222 at risk
EG0016 events6 affected245 at risk
EG0029 events8 affected237 at risk
EG003
Influenza
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected222 at risk
EG0011 events1 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0004 events4 affected222 at risk
EG0011 events1 affected245 at risk
EG0025 events5 affected237 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0015 events5 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Seborrheic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected222 at risk
EG0010 events0 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected222 at risk
EG0013 events3 affected245 at risk
EG0025 events5 affected237 at risk
EG003
Asthenia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0012 events2 affected245 at risk
EG0022 events2 affected237 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0003 events3 affected222 at risk
EG0012 events2 affected245 at risk
EG0020 events0 affected237 at risk
EG003
Oedema peripheral
General disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected222 at risk
EG0011 events1 affected245 at risk
EG0021 events1 affected237 at risk
EG003
Fatigue
General disorders
MedDRA (25.0)
Systematic Assessment
EG0007 events7 affected222 at risk
EG0015 events5 affected245 at risk
EG0024 events4 affected237 at risk
EG003
Pyrexia
General disorders
MedDRA (25.0)
Systematic Assessment
EG00011 events10 affected222 at risk
EG00110 events10 affected245 at risk
EG0027 events6 affected237 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
The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, >=1).
Cochran-Mantel-Haenszel
0.1730
Stratified Percentage Difference
5.2
2-Sided
95
-2.4
12.7
Superiority
OG003
OG005
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (<=1, >1).
Cochran-Mantel-Haenszel
0.0023
Stratified Percentage Difference
12.0
2-Sided
95
4.1
19.9
Superiority
OG004
OG005
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (<=1, >1).
Cochran-Mantel-Haenszel
0.6038
Stratified Percentage Difference
1.8
2-Sided
95
-5.2
8.7
Superiority
OG002
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG003
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG004
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG005
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Units
Counts
Participants
OG000222
OG001245
OG002237
OG003202
OG004228
OG005229
Title
Denominators
Categories
Title
Measurements
OG00023.9(18.0 to 29.7)
OG00120.8(15.5 to 26.1)
OG00218.1(13.0 to 23.3)
OG00311.9(7.2 to 16.6)
OG00413.6(8.9 to 18.3)
OG00511.4(7.0 to 15.7)
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
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, >=1).
Cochran-Mantel-Haenszel
CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (0, >=1) at Day 1.
0.1365
Stratified Percentage Difference
5.5
2-Sided
95
-2.0
12.9
Superiority
OG001
OG002
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, >=1).
Cochran-Mantel-Haenszel
0.5103
Stratified Percentage Difference
2.4
2-Sided
95
-4.8
9.5
Superiority
OG003
OG005
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (<=1, >1).
Cochran-Mantel-Haenszel
CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (<=1, >1) at Day 1.
0.9797
Stratified Percentage Difference
0.1
2-Sided
95
-6.5
6.6
Superiority
OG004
OG005
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (<=1, >1).
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG002
Filgotinib 200 mg - Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG003
Filgotinib 100 mg - Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
OG000112
OG00198
OG00253
OG00353
Title
Denominators
Categories
Title
Measurements
OG00042.9(33.2 to 52.5)
OG00123.5(14.6 to 32.4)
OG00228.3(15.2 to 41.4)
OG00322.6(10.4 to 34.9)
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
CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.0839
Stratified Percentage Difference
13.7
2-Sided
95
-1.0
28.4
Superiority
OG001
OG003
CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.8288
Stratified Percentage Difference
1.5
2-Sided
95
-12.1
15.0
Superiority
OG002
Filgotinib 200 mg - Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG003
Filgotinib 100 mg - Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
OG000112
OG00198
OG00253
OG00353
Title
Denominators
Categories
Title
Measurements
OG00030.4(21.4 to 39.3)
OG00118.4(10.2 to 26.5)
OG0029.4(0.6 to 18.2)
OG00313.2(3.1 to 23.3)
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
CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.0038
Stratified Percentage Difference
20.6
2-Sided
95
8.2
33.1
Superiority
OG001
OG003
CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.3466
Stratified Percentage Difference
5.8
2-Sided
95
-6.6
18.3
Superiority
OG003
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG004
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG005
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Units
Counts
Participants
OG000222
OG001245
OG002237
OG003202
OG004228
OG005229
Title
Denominators
Categories
Title
Measurements
OG00032.9(26.5 to 39.3)
OG00130.6(24.6 to 36.6)
OG00225.7(20.0 to 31.5)
OG00329.7(23.2 to 36.3)
OG00418.9(13.6 to 24.2)
OG00517.9(12.7 to 23.1)
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
OG002
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, >=1).
Cochran-Mantel-Haenszel
0.0963
Stratified Percentage Difference
6.9
2-Sided
95
-1.4
15.2
Superiority
OG001
OG002
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, >=1).
Cochran-Mantel-Haenszel
0.3050
Stratified Percentage Difference
4.2
2-Sided
95
-3.9
12.2
Superiority
OG003
OG005
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (<=1, >1).
Cochran-Mantel-Haenszel
0.0039
Stratified Percentage Difference
11.9
2-Sided
95
3.7
20.2
Superiority
OG004
OG005
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (<=1, >1).
Cochran-Mantel-Haenszel
0.7556
Stratified Percentage Difference
1.1
2-Sided
95
-6.2
8.5
Superiority
OG002
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG003
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
OG004
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
OG005
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Units
Counts
Participants
OG000222
OG001245
OG002237
OG003202
OG004228
OG005229
Title
Denominators
Categories
Title
Measurements
OG00052.3(45.5 to 59.0)
OG00146.1(39.7 to 52.6)
OG00239.7(33.2 to 46.1)
OG00338.6(31.7 to 45.6)
OG00435.5(29.1 to 42.0)
OG00527.5(21.5 to 33.5)
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
OG002
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).
Cochran-Mantel-Haenszel
0.0074
Stratified Percentage Difference
12.0
2-Sided
95
3.2
20.8
Superiority
OG001
OG002
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).
Cochran-Mantel-Haenszel
0.2159
Stratified Percentage Difference
5.5
2-Sided
95
-3.2
14.1
Superiority
OG003
OG005
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (<=1, >1).
Cochran-Mantel-Haenszel
0.0110
Stratified Percentage Difference
11.6
2-Sided
95
2.6
20.6
Superiority
OG004
OG005
CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (<=1, >1).
Cochran-Mantel-Haenszel
0.0593
Stratified Percentage Difference
8.2
2-Sided
95
-0.4
16.7
Superiority
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG003
Filgotinib 100 mg - Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
OG000112
OG00198
OG00253
OG00353
Title
Denominators
Categories
Title
Measurements
OG00043.8(34.1 to 53.4)
OG00129.6(20.0 to 39.1)
OG00226.4(13.6 to 39.2)
OG00324.5(12.0 to 37.1)
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
OG002
CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.0382
Stratified Percentage Difference
16.8
2-Sided
95
2.0
31.6
Superiority
OG001
OG003
CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.4263
Stratified Percentage Difference
5.8
2-Sided
95
-8.5
20.0
Superiority
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG002
Filgotinib 200 mg - Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG003
Filgotinib 100 mg - Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
OG000112
OG00198
OG00253
OG00353
Title
Denominators
Categories
Title
Measurements
OG00045.5(35.9 to 55.2)
OG00133.7(23.8 to 43.5)
OG00234.0(20.3 to 47.7)
OG00330.2(16.9 to 43.5)
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
OG002
CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.1827
Stratified Percentage Difference
10.9
2-Sided
95
-4.7
26.4
Superiority
OG001
OG003
CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.5944
Stratified Percentage Difference
4.0
2-Sided
95
-11.1
19.2
Superiority
OG002
Filgotinib 200 mg - Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG003
Filgotinib 100 mg - Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
OG000112
OG00198
OG00253
OG00353
Title
Denominators
Categories
Title
Measurements
OG00038.4(28.9 to 47.8)
OG00119.4(11.1 to 27.7)
OG00222.6(10.4 to 34.9)
OG00320.8(8.9 to 32.6)
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
CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.0512
Stratified Percentage Difference
15.2
2-Sided
95
1.0
29.3
Superiority
OG001
OG003
CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.9801
Stratified Percentage Difference
-0.2
2-Sided
95
-13.3
13.0
Superiority
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG002
Filgotinib 200 mg - Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG003
Filgotinib 100 mg - Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
OG00050
OG00141
OG00225
OG00325
Title
Denominators
Categories
Title
Measurements
OG00034.0(19.9 to 48.1)
OG0014.9(0.0 to 12.7)
OG00220.0(2.3 to 37.7)
OG00312.0(0.0 to 26.7)
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
CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).
Cochran-Mantel-Haenszel
0.1900
Stratified Percentage Difference
14.0
2-Sided
95
-5.1
33.1
Superiority
OG001
OG003
CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).
Cochran-Mantel-Haenszel
0.4248
Stratified Percentage Difference
-5.5
2-Sided
95
-22.6
11.6
Superiority
Filgotinib 200 mg - Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG003
Filgotinib 100 mg - Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
OG000112
OG00198
OG00253
OG00353
Title
Denominators
Categories
Title
Measurements
OG00041.1(31.5 to 50.6)
OG00125.5(16.4 to 34.7)
OG00220.8(8.9 to 32.6)
OG00324.5(12.0 to 37.1)
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
OG002
CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.0122
Stratified Percentage Difference
19.9
2-Sided
95
5.7
34.0
Superiority
OG001
OG003
CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).
Cochran-Mantel-Haenszel
0.7708
Stratified Percentage Difference
2.0
2-Sided
95
-12.0
16.1
Superiority
OG002
Filgotinib 200 mg - Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
OG003
Filgotinib 100 mg - Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Units
Counts
Participants
OG00050
OG00141
OG00225
OG00325
Title
Denominators
Categories
Title
Measurements
OG00032.0(18.1 to 45.9)
OG0017.3(0.0 to 16.5)
OG00220.0(2.3 to 37.7)
OG00312.0(0.0 to 26.7)
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
CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).
Cochran-Mantel-Haenszel
0.2631
Stratified Percentage Difference
12.0
2-Sided
95
-8.3
32.3
Superiority
OG001
OG003
CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).
Cochran-Mantel-Haenszel
0.6444
Stratified Percentage Difference
-3.4
2-Sided
95
-20.9
14.0
Superiority
OG003
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Units
Counts
Participants
OG000177
OG001181
OG002141
OG003168
Title
Denominators
Categories
Title
Measurements
OG0001170± 1270
OG001611± 634
OG0021140± 1070
OG003604± 634
Units
Counts
Participants
OG000183
OG001180
OG002136
OG003135
Title
Denominators
Categories
Title
Measurements
OG00046.8± 180
OG00121.3± 79.5
OG00247.9± 215
OG00340.8± 139
OG00077
OG00163
Title
Denominators
Categories
Title
Measurements
OG000284± 623
OG00158.5± 150
OG00034
OG00127
Title
Denominators
Categories
Title
Measurements
OG00075.8± 238
OG00116.9± 55.5
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Units
Counts
Participants
OG000177
OG001181
OG002141
OG003168
Title
Denominators
Categories
Title
Measurements
OG0003100± 1530
OG0011800± 936
OG0023140± 1450
OG0031870± 776
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.