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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02914522




Registration number
NCT02914522
Ethics application status
Date submitted
22/09/2016
Date registered
26/09/2016
Date last updated
21/04/2021

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Scientific title
Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2016-001392-78
Secondary ID [2] 0 0
GS-US-418-3898
Universal Trial Number (UTN)
Trial acronym
SELECTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - PTM filgotinib

Experimental: Induction Study (Cohort A): Filgotinib 200 mg - Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.

Experimental: Induction Study (Cohort A): Filgotinib 100 mg - Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

Placebo Comparator: Induction Study (Cohort A): Placebo - Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

Experimental: Induction Study (Cohort B): Filgotinib 200 mg - Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

Experimental: Induction Study (Cohort B): Filgotinib 100 mg - Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

Placebo Comparator: Induction Study (Cohort B): Placebo - Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

Experimental: Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg - Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58).

Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 200 mg - Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

Experimental: Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg - Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58).

Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 100 mg - Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

Placebo Comparator: Maintenance Study: Placebo From Induction Placebo - Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58).


Treatment: Drugs: Filgotinib
Tablet(s) administered orally once daily

Treatment: Drugs: PTM filgotinib
Tablet(s) administered orally once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 - EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Timepoint [1] 0 0
Week 10
Primary outcome [2] 0 0
Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 - EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Timepoint [2] 0 0
Week 58
Secondary outcome [1] 0 0
Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10 - MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Timepoint [1] 0 0
Week 10
Secondary outcome [2] 0 0
Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10 - Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Timepoint [2] 0 0
Week 10
Secondary outcome [3] 0 0
Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10 - Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Timepoint [3] 0 0
Week 10
Secondary outcome [4] 0 0
Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10 - MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of = 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Timepoint [4] 0 0
Week 10
Secondary outcome [5] 0 0
Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845 - Cmax is defined as the maximum observed concentration of drug.
Timepoint [5] 0 0
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Secondary outcome [6] 0 0
Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845 - Tmax is defined as the time to reach maximum observed concentration of drug.
Timepoint [6] 0 0
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Secondary outcome [7] 0 0
Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984 - AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Timepoint [7] 0 0
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Secondary outcome [8] 0 0
Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984 - AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Timepoint [8] 0 0
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Secondary outcome [9] 0 0
Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984 - Ctau is defined as the observed drug concentration at the end of the dosing interval.
Timepoint [9] 0 0
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Secondary outcome [10] 0 0
Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58 - MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Timepoint [10] 0 0
Week 58
Secondary outcome [11] 0 0
Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58 - Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58.
Timepoint [11] 0 0
Week 58
Secondary outcome [12] 0 0
Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58 - Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58.
Timepoint [12] 0 0
Week 58
Secondary outcome [13] 0 0
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58 - Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Timepoint [13] 0 0
Week 58
Secondary outcome [14] 0 0
Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58 - Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Timepoint [14] 0 0
Week 58
Secondary outcome [15] 0 0
Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58 - MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of = 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Timepoint [15] 0 0
Week 58
Secondary outcome [16] 0 0
Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845 - Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845.
Timepoint [16] 0 0
Week 26 (any Time) and Week 58 (predose)

Eligibility
Key inclusion criteria
Key

- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
the date of the screening visit

- Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of
15 cm from the anal verge. Documentation should include endoscopic and histopathologic
evidence of UC.

- A surveillance colonoscopy is required at screening in individuals with a history of
UC for 8 or more years, if one was not performed in the prior 24 months

- Moderately to severely active UC

- Previously demonstrated an inadequate clinical response, loss of response to, or
intolerance to at least 1 of the following agents (depending on current country
treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor
necrosis factor alpha (TNFa) antagonists, or vedolizumab

Key
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant
colitis, ulcerative proctitis, or toxic mega-colon

- Active tuberculosis (TB) or history of latent TB that has not been treated

- Use of any concomitant prohibited medications as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Coastal Digestive Health - Mountain Creek
Recruitment hospital [4] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Footscray Hospital - Footscray
Recruitment hospital [9] 0 0
Austin Health - Heidelberg
Recruitment hospital [10] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [11] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
4557 - Mountain Creek
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3011 - Footscray
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Quilmes
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Hannöver
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Herne
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Jena
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Kiel
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Koln
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Leipzig
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Lüneburg
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Minden
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Muenchen
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Germany
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Tuebingen
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Germany
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Ulm
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Greece
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Athens
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Hong Kong
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Hong Kong
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Hong Kong
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Sha Tin
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Hungary
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Budapest
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Hungary
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Békéscsaba
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Hungary
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Debrecen
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Hungary
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Gyöngyös
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Hungary
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Mosonmagyaróvár
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India
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Ahmedabad
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India
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Bangalore
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India
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Chennai
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India
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Coimbatore
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India
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Hyderabad
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India
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Jaipur
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India
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Kolkata
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India
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Ludhiana
Country [102] 0 0
India
State/province [102] 0 0
Mangaluru
Country [103] 0 0
India
State/province [103] 0 0
Mumbai
Country [104] 0 0
India
State/province [104] 0 0
Nagpur
Country [105] 0 0
India
State/province [105] 0 0
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Country [106] 0 0
India
State/province [106] 0 0
Pune
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India
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Rajkot
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India
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Secunderabad
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India
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Surat
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India
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Udupi
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India
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Catanzaro
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Italy
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Chieti
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Italy
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Milano
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Italy
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Padova
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Italy
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Pisa
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Italy
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Rozzano
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Japan
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Bunkyo-ku
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Japan
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Chikushino-shi
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Japan
State/province [128] 0 0
Chuo-Ku
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Japan
State/province [129] 0 0
Fukuoka-shi
Country [130] 0 0
Japan
State/province [130] 0 0
Hachioji-shi
Country [131] 0 0
Japan
State/province [131] 0 0
Hiroshima-shi
Country [132] 0 0
Japan
State/province [132] 0 0
Jonan-ku
Country [133] 0 0
Japan
State/province [133] 0 0
Kamakura
Country [134] 0 0
Japan
State/province [134] 0 0
Kitakyushu-shi
Country [135] 0 0
Japan
State/province [135] 0 0
Kofu-shi
Country [136] 0 0
Japan
State/province [136] 0 0
Kurume-shi
Country [137] 0 0
Japan
State/province [137] 0 0
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Country [138] 0 0
Japan
State/province [138] 0 0
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Country [139] 0 0
Japan
State/province [139] 0 0
Minato-ku
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Japan
State/province [140] 0 0
Mitaka-shi
Country [141] 0 0
Japan
State/province [141] 0 0
Morioka-shi
Country [142] 0 0
Japan
State/province [142] 0 0
Nagakute-shi
Country [143] 0 0
Japan
State/province [143] 0 0
Nagasaki-shi
Country [144] 0 0
Japan
State/province [144] 0 0
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Country [145] 0 0
Japan
State/province [145] 0 0
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Country [146] 0 0
Japan
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Country [147] 0 0
Japan
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Okayama-city
Country [148] 0 0
Japan
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Osaka
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Japan
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Country [150] 0 0
Japan
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Saga
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Saitama
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Sakura
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Japan
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Japan
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Japan
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Shinjuku-ku
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Japan
State/province [158] 0 0
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Country [159] 0 0
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Country [160] 0 0
Japan
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Ukraine
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Country [235] 0 0
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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Country [254] 0 0
United Kingdom
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Oxford
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Prescot
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Galapagos NV
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of this study are to evaluate the efficacy of filgotinib in the
induction and maintenance treatment of moderately to severely active ulcerative colitis (UC)
in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or met protocol specified efficacy discontinuation
criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead
Study GS-US-418-3899: NCT02914535).
Trial website
https://clinicaltrials.gov/show/NCT02914522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications