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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02914561




Registration number
NCT02914561
Ethics application status
Date submitted
22/09/2016
Date registered
26/09/2016

Titles & IDs
Public title
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
2016-001367-36
Secondary ID [2] 0 0
GS-US-419-3895
Universal Trial Number (UTN)
Trial acronym
DIVERSITY1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Other interventions - Placebo

Experimental: Cohort A: Filgotinib 200 (mg) (Induction Study) - 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.

Experimental: 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.

Placebo comparator: 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.

Experimental: 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.

Experimental: 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.

Placebo comparator: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Placebo comparator: 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.


Treatment: Drugs: Filgotinib
Filgotinib tablets administered orally once daily.

Other interventions: Placebo
Placebo administered orally once daily.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
Timepoint [1] 0 0
Week 10
Primary outcome [2] 0 0
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
Timepoint [2] 0 0
Week 10
Primary outcome [3] 0 0
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
Timepoint [3] 0 0
Week 58
Primary outcome [4] 0 0
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
Timepoint [4] 0 0
Week 58
Secondary outcome [1] 0 0
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
Timepoint [1] 0 0
Week 10
Secondary outcome [2] 0 0
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
Timepoint [2] 0 0
Week 10
Secondary outcome [3] 0 0
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
Timepoint [3] 0 0
Week 58
Secondary outcome [4] 0 0
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
Timepoint [4] 0 0
Week 58
Secondary outcome [5] 0 0
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
Timepoint [5] 0 0
Weeks 10 and 58
Secondary outcome [6] 0 0
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
Timepoint [6] 0 0
Week 58
Secondary outcome [7] 0 0
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
Timepoint [7] 0 0
Weeks 10 and 58
Secondary outcome [8] 0 0
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
Timepoint [8] 0 0
Week 58
Secondary outcome [9] 0 0
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
Timepoint [9] 0 0
Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
Secondary outcome [10] 0 0
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
Timepoint [10] 0 0
Week 10: Predose
Secondary outcome [11] 0 0
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
Timepoint [11] 0 0
Week 26: At any timepoint
Secondary outcome [12] 0 0
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
Timepoint [12] 0 0
Week 58: Pre-dose
Secondary outcome [13] 0 0
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
Timepoint [13] 0 0
Week 4: 0.5, 1, 2, and 3 hrs post dose
Secondary outcome [14] 0 0
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10
Timepoint [14] 0 0
Week 10: Predose
Secondary outcome [15] 0 0
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
Timepoint [15] 0 0
Week 26: At any timepoint
Secondary outcome [16] 0 0
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
Timepoint [16] 0 0
Week 58: Pre-dose

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
31/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/11/2022
Sample size
Target
Accrual to date
Final
1372
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [4] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [6] 0 0
Coastal Digestive Health - Mountain Creek
Recruitment hospital [7] 0 0
Coral Sea Clinical Research Institute (Mackay) - North Mackay
Recruitment hospital [8] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [11] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [12] 0 0
Emeritus Research - Camberwell
Recruitment hospital [13] 0 0
Footscray Hospital - Footscray
Recruitment hospital [14] 0 0
Austin Health - Heidelberg
Recruitment hospital [15] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [16] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [17] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4557 - Mountain Creek
Recruitment postcode(s) [7] 0 0
4740 - North Mackay
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5042 - Bedford Park
Recruitment postcode(s) [11] 0 0
5011 - Woodville South
Recruitment postcode(s) [12] 0 0
3124 - Camberwell
Recruitment postcode(s) [13] 0 0
3011 - Footscray
Recruitment postcode(s) [14] 0 0
3084 - Heidelberg
Recruitment postcode(s) [15] 0 0
3144 - Malvern
Recruitment postcode(s) [16] 0 0
3004 - Melbourne
Recruitment postcode(s) [17] 0 0
3050 - Parkville
Recruitment outside Australia
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State/province [161] 0 0
Petah Tikva
Country [162] 0 0
Israel
State/province [162] 0 0
Ramat Gan
Country [163] 0 0
Israel
State/province [163] 0 0
Tel Aviv-Yafo
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Italy
State/province [164] 0 0
Castellana Grotte
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Italy
State/province [165] 0 0
Catanzaro
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Italy
State/province [166] 0 0
Cento
Country [167] 0 0
Italy
State/province [167] 0 0
Chieti
Country [168] 0 0
Italy
State/province [168] 0 0
Firenze
Country [169] 0 0
Italy
State/province [169] 0 0
Milano
Country [170] 0 0
Italy
State/province [170] 0 0
Modena
Country [171] 0 0
Italy
State/province [171] 0 0
Padova
Country [172] 0 0
Italy
State/province [172] 0 0
Pisa
Country [173] 0 0
Italy
State/province [173] 0 0
Roma
Country [174] 0 0
Italy
State/province [174] 0 0
Rozzano
Country [175] 0 0
Italy
State/province [175] 0 0
Torino
Country [176] 0 0
Japan
State/province [176] 0 0
Ageo-shi
Country [177] 0 0
Japan
State/province [177] 0 0
Bunkyo-ku
Country [178] 0 0
Japan
State/province [178] 0 0
Chuo-ku
Country [179] 0 0
Japan
State/province [179] 0 0
Fukuoka-shi
Country [180] 0 0
Japan
State/province [180] 0 0
Hachioji
Country [181] 0 0
Japan
State/province [181] 0 0
Hamamatsu-shi
Country [182] 0 0
Japan
State/province [182] 0 0
Hiroshima-shi
Country [183] 0 0
Japan
State/province [183] 0 0
Hiroshima
Country [184] 0 0
Japan
State/province [184] 0 0
Jonan-ku
Country [185] 0 0
Japan
State/province [185] 0 0
Kagoshima-shi
Country [186] 0 0
Japan
State/province [186] 0 0
Kamakura
Country [187] 0 0
Japan
State/province [187] 0 0
Kashiwa-city
Country [188] 0 0
Japan
State/province [188] 0 0
Kawagoe
Country [189] 0 0
Japan
State/province [189] 0 0
Kitakyushu-shi
Country [190] 0 0
Japan
State/province [190] 0 0
Kofu-shi
Country [191] 0 0
Japan
State/province [191] 0 0
Kurume-shi
Country [192] 0 0
Japan
State/province [192] 0 0
Kyoto-shi
Country [193] 0 0
Japan
State/province [193] 0 0
Minato-ku
Country [194] 0 0
Japan
State/province [194] 0 0
Mitaka-shi
Country [195] 0 0
Japan
State/province [195] 0 0
Morioka-shi
Country [196] 0 0
Japan
State/province [196] 0 0
Nagakute-shi
Country [197] 0 0
Japan
State/province [197] 0 0
Nagasaki-shi
Country [198] 0 0
Japan
State/province [198] 0 0
Nagoya
Country [199] 0 0
Japan
State/province [199] 0 0
Nishi-ku
Country [200] 0 0
Japan
State/province [200] 0 0
Nishinomiya
Country [201] 0 0
Japan
State/province [201] 0 0
Oita-shi
Country [202] 0 0
Japan
State/province [202] 0 0
Okayama-city
Country [203] 0 0
Japan
State/province [203] 0 0
Osaka-City
Country [204] 0 0
Japan
State/province [204] 0 0
Osaka
Country [205] 0 0
Japan
State/province [205] 0 0
Otsu
Country [206] 0 0
Japan
State/province [206] 0 0
Saga-shi
Country [207] 0 0
Japan
State/province [207] 0 0
Sagamihara
Country [208] 0 0
Japan
State/province [208] 0 0
Saga
Country [209] 0 0
Japan
State/province [209] 0 0
Saitama
Country [210] 0 0
Japan
State/province [210] 0 0
Sakura
Country [211] 0 0
Japan
State/province [211] 0 0
Sapporo-shi
Country [212] 0 0
Japan
State/province [212] 0 0
Sapporo
Country [213] 0 0
Japan
State/province [213] 0 0
Sendai
Country [214] 0 0
Japan
State/province [214] 0 0
Shinjuku-ku
Country [215] 0 0
Japan
State/province [215] 0 0
Suita
Country [216] 0 0
Japan
State/province [216] 0 0
Takamatsu-shi
Country [217] 0 0
Japan
State/province [217] 0 0
Takasaki-shi
Country [218] 0 0
Japan
State/province [218] 0 0
Takatsuki
Country [219] 0 0
Japan
State/province [219] 0 0
Toyota-shi
Country [220] 0 0
Japan
State/province [220] 0 0
Wakayama-shi
Country [221] 0 0
Japan
State/province [221] 0 0
Yokohama-shi
Country [222] 0 0
Korea, Republic of
State/province [222] 0 0
Busan
Country [223] 0 0
Korea, Republic of
State/province [223] 0 0
Daegu
Country [224] 0 0
Korea, Republic of
State/province [224] 0 0
Guri-Si
Country [225] 0 0
Korea, Republic of
State/province [225] 0 0
Gyeonggi-do
Country [226] 0 0
Korea, Republic of
State/province [226] 0 0
Seongnam-si
Country [227] 0 0
Korea, Republic of
State/province [227] 0 0
Seoul
Country [228] 0 0
Korea, Republic of
State/province [228] 0 0
Suwon-si
Country [229] 0 0
Korea, Republic of
State/province [229] 0 0
Wonju
Country [230] 0 0
Malaysia
State/province [230] 0 0
Cheras
Country [231] 0 0
Malaysia
State/province [231] 0 0
George Town
Country [232] 0 0
Malaysia
State/province [232] 0 0
Kota Kinabalu
Country [233] 0 0
Malaysia
State/province [233] 0 0
Kuala Lumpur
Country [234] 0 0
Malaysia
State/province [234] 0 0
Kuantan
Country [235] 0 0
Netherlands
State/province [235] 0 0
Alkmaar
Country [236] 0 0
Netherlands
State/province [236] 0 0
Amsterdam
Country [237] 0 0
Netherlands
State/province [237] 0 0
Apeldoorn
Country [238] 0 0
Netherlands
State/province [238] 0 0
Groningen
Country [239] 0 0
Netherlands
State/province [239] 0 0
Maastricht
Country [240] 0 0
Netherlands
State/province [240] 0 0
Rotterdam
Country [241] 0 0
Netherlands
State/province [241] 0 0
Tilburg
Country [242] 0 0
Netherlands
State/province [242] 0 0
Utrecht
Country [243] 0 0
New Zealand
State/province [243] 0 0
Christchurch
Country [244] 0 0
New Zealand
State/province [244] 0 0
Dunedin
Country [245] 0 0
New Zealand
State/province [245] 0 0
Grafton
Country [246] 0 0
New Zealand
State/province [246] 0 0
Hamilton
Country [247] 0 0
New Zealand
State/province [247] 0 0
Newtown
Country [248] 0 0
New Zealand
State/province [248] 0 0
Tauranga
Country [249] 0 0
New Zealand
State/province [249] 0 0
Wellington
Country [250] 0 0
Norway
State/province [250] 0 0
Drammen
Country [251] 0 0
Poland
State/province [251] 0 0
Bialystok
Country [252] 0 0
Poland
State/province [252] 0 0
Bydgoszcz
Country [253] 0 0
Poland
State/province [253] 0 0
Czestochowa
Country [254] 0 0
Poland
State/province [254] 0 0
Katowice
Country [255] 0 0
Poland
State/province [255] 0 0
Krakow
Country [256] 0 0
Poland
State/province [256] 0 0
Kraków
Country [257] 0 0
Poland
State/province [257] 0 0
Lodz
Country [258] 0 0
Poland
State/province [258] 0 0
Piotrków Trybunalski
Country [259] 0 0
Poland
State/province [259] 0 0
Poznan
Country [260] 0 0
Poland
State/province [260] 0 0
Rzeszów
Country [261] 0 0
Poland
State/province [261] 0 0
Sopot
Country [262] 0 0
Poland
State/province [262] 0 0
Szczecin
Country [263] 0 0
Poland
State/province [263] 0 0
Torun
Country [264] 0 0
Poland
State/province [264] 0 0
Tychy
Country [265] 0 0
Poland
State/province [265] 0 0
Warsaw
Country [266] 0 0
Poland
State/province [266] 0 0
Warszawa
Country [267] 0 0
Poland
State/province [267] 0 0
Wroclaw
Country [268] 0 0
Portugal
State/province [268] 0 0
Braga
Country [269] 0 0
Portugal
State/province [269] 0 0
Coimbra
Country [270] 0 0
Portugal
State/province [270] 0 0
Covilhã
Country [271] 0 0
Portugal
State/province [271] 0 0
Faro
Country [272] 0 0
Portugal
State/province [272] 0 0
Guimaraes
Country [273] 0 0
Portugal
State/province [273] 0 0
Loures
Country [274] 0 0
Portugal
State/province [274] 0 0
Porto
Country [275] 0 0
Portugal
State/province [275] 0 0
Viana do Castelo
Country [276] 0 0
Romania
State/province [276] 0 0
Bucharest
Country [277] 0 0
Romania
State/province [277] 0 0
Bucuresti
Country [278] 0 0
Romania
State/province [278] 0 0
Iasi
Country [279] 0 0
Romania
State/province [279] 0 0
Timisoara
Country [280] 0 0
Russian Federation
State/province [280] 0 0
Chelyabinsk
Country [281] 0 0
Russian Federation
State/province [281] 0 0
Irkutsk
Country [282] 0 0
Russian Federation
State/province [282] 0 0
Moscow
Country [283] 0 0
Russian Federation
State/province [283] 0 0
Nizhniy Novgorod
Country [284] 0 0
Russian Federation
State/province [284] 0 0
Novosibirsk
Country [285] 0 0
Russian Federation
State/province [285] 0 0
Saint-Petersburg
Country [286] 0 0
Russian Federation
State/province [286] 0 0
Saratov
Country [287] 0 0
Serbia
State/province [287] 0 0
Belgrade
Country [288] 0 0
Serbia
State/province [288] 0 0
Novi Sad
Country [289] 0 0
Singapore
State/province [289] 0 0
Singapore
Country [290] 0 0
Slovakia
State/province [290] 0 0
Bratislava
Country [291] 0 0
Slovakia
State/province [291] 0 0
Nitra
Country [292] 0 0
Slovakia
State/province [292] 0 0
Presov
Country [293] 0 0
South Africa
State/province [293] 0 0
Cape Town
Country [294] 0 0
South Africa
State/province [294] 0 0
Johannesburg
Country [295] 0 0
Spain
State/province [295] 0 0
Badalona
Country [296] 0 0
Spain
State/province [296] 0 0
Barcelona
Country [297] 0 0
Spain
State/province [297] 0 0
Ferrol
Country [298] 0 0
Spain
State/province [298] 0 0
Las Palmas de Gran Canaria
Country [299] 0 0
Spain
State/province [299] 0 0
Madrid
Country [300] 0 0
Spain
State/province [300] 0 0
Oviedo
Country [301] 0 0
Spain
State/province [301] 0 0
Pontevedra
Country [302] 0 0
Spain
State/province [302] 0 0
Sagunto
Country [303] 0 0
Spain
State/province [303] 0 0
Sevilla
Country [304] 0 0
Spain
State/province [304] 0 0
Usansolo
Country [305] 0 0
Sri Lanka
State/province [305] 0 0
Colombo
Country [306] 0 0
Sri Lanka
State/province [306] 0 0
Galle
Country [307] 0 0
Sri Lanka
State/province [307] 0 0
Kandy
Country [308] 0 0
Sri Lanka
State/province [308] 0 0
Ragama
Country [309] 0 0
Sweden
State/province [309] 0 0
Danderyd
Country [310] 0 0
Sweden
State/province [310] 0 0
Uppsala
Country [311] 0 0
Switzerland
State/province [311] 0 0
Bern
Country [312] 0 0
Switzerland
State/province [312] 0 0
Zurich
Country [313] 0 0
Taiwan
State/province [313] 0 0
Changhua
Country [314] 0 0
Taiwan
State/province [314] 0 0
Kaohsiung
Country [315] 0 0
Taiwan
State/province [315] 0 0
New Taipei City
Country [316] 0 0
Taiwan
State/province [316] 0 0
Taichung
Country [317] 0 0
Taiwan
State/province [317] 0 0
Tainan City
Country [318] 0 0
Taiwan
State/province [318] 0 0
Taipei
Country [319] 0 0
Taiwan
State/province [319] 0 0
Taoyuan
Country [320] 0 0
Ukraine
State/province [320] 0 0
Chernivtsi
Country [321] 0 0
Ukraine
State/province [321] 0 0
Dnipropetrovsk
Country [322] 0 0
Ukraine
State/province [322] 0 0
Ivano-Frankivsk
Country [323] 0 0
Ukraine
State/province [323] 0 0
Kharkiv
Country [324] 0 0
Ukraine
State/province [324] 0 0
Kropyvnytskyi
Country [325] 0 0
Ukraine
State/province [325] 0 0
Kyiv
Country [326] 0 0
Ukraine
State/province [326] 0 0
Odessa
Country [327] 0 0
Ukraine
State/province [327] 0 0
Ternopil
Country [328] 0 0
Ukraine
State/province [328] 0 0
Uzhgorod
Country [329] 0 0
Ukraine
State/province [329] 0 0
Vinnytsia
Country [330] 0 0
Ukraine
State/province [330] 0 0
Zaporizhzhya
Country [331] 0 0
United Kingdom
State/province [331] 0 0
Norfolk
Country [332] 0 0
United Kingdom
State/province [332] 0 0
Birmingham
Country [333] 0 0
United Kingdom
State/province [333] 0 0
Bury
Country [334] 0 0
United Kingdom
State/province [334] 0 0
Cambridge
Country [335] 0 0
United Kingdom
State/province [335] 0 0
Derby
Country [336] 0 0
United Kingdom
State/province [336] 0 0
Edinburgh
Country [337] 0 0
United Kingdom
State/province [337] 0 0
Exeter
Country [338] 0 0
United Kingdom
State/province [338] 0 0
Glasgow
Country [339] 0 0
United Kingdom
State/province [339] 0 0
High Wycombe
Country [340] 0 0
United Kingdom
State/province [340] 0 0
Hull
Country [341] 0 0
United Kingdom
State/province [341] 0 0
London
Country [342] 0 0
United Kingdom
State/province [342] 0 0
Oxford
Country [343] 0 0
United Kingdom
State/province [343] 0 0
Prescot
Country [344] 0 0
United Kingdom
State/province [344] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Galapagos Study Director
Address 0 0
Galapagos NV
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02914561