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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02914600




Registration number
NCT02914600
Ethics application status
Date submitted
22/09/2016
Date registered
26/09/2016

Titles & IDs
Public title
Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
Scientific title
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
Secondary ID [1] 0 0
2016-002763-34
Secondary ID [2] 0 0
GS-US-419-3896
Universal Trial Number (UTN)
Trial acronym
DIVERSITY LTE
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
Treatment: Drugs - Placebo

Experimental: Filgotinib 200 mg - Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg.

Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study.

Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Experimental: Filgotinib 100 mg - Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg.

Male participants from the US \& Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study.

Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Placebo comparator: Placebo - Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation.

Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks).


Treatment: Drugs: Filgotinib
Tablet administered orally once a day

Treatment: Drugs: Placebo
Tablet administered orally once a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From the First Dose to Week 312
Secondary outcome [1] 0 0
Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools
Timepoint [1] 0 0
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Secondary outcome [2] 0 0
Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain
Timepoint [2] 0 0
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300
Secondary outcome [3] 0 0
Change From Baseline in CDAI Scores
Timepoint [3] 0 0
Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300

Eligibility
Key inclusion criteria
Key

* Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
* Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
* Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
* Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
* Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
* Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known hypersensitivity to the study drug
* Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
* Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
* Use of prohibited concomitant medications as outlined in the study protocol

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2023
Sample size
Target
Accrual to date
Final
1188
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
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
Coastal Digestive Health - Mountain Creek
Recruitment hospital [6] 0 0
Coral Sea Clinical Research Institute (Mackay) - North Mackay
Recruitment hospital [7] 0 0
Mater Misericordiae Ltd - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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The Queen Elizabeth Hospital - Woodville South
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Emeritus Research - Camberwell
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Monash Medical Centre - Clayton
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Footscray Hospital - Footscray
Recruitment hospital [13] 0 0
Austin Health - Heidelberg
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Cabrini Hospital - Malvern
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Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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2010 - Darlinghurst
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2747 - Kingswood
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2500 - Wollongong
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4557 - Mountain Creek
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4740 - North Mackay
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4101 - South Brisbane
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4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5011 - Woodville South
Recruitment postcode(s) [10] 0 0
3124 - Camberwell
Recruitment postcode(s) [11] 0 0
3168 - Clayton
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3011 - Footscray
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3084 - Heidelberg
Recruitment postcode(s) [14] 0 0
3144 - Malvern
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3004 - Melbourne
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3050 - Parkville
Recruitment outside Australia
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State/province [206] 0 0
Takasaki-shi
Country [207] 0 0
Japan
State/province [207] 0 0
Toyota-shi
Country [208] 0 0
Japan
State/province [208] 0 0
Wakayama-shi
Country [209] 0 0
Japan
State/province [209] 0 0
Yokohama-shi
Country [210] 0 0
Korea, Republic of
State/province [210] 0 0
Busan
Country [211] 0 0
Korea, Republic of
State/province [211] 0 0
Daegu
Country [212] 0 0
Korea, Republic of
State/province [212] 0 0
Guri-Si
Country [213] 0 0
Korea, Republic of
State/province [213] 0 0
Gyeonggi-do
Country [214] 0 0
Korea, Republic of
State/province [214] 0 0
Seongnam-si
Country [215] 0 0
Korea, Republic of
State/province [215] 0 0
Seoul
Country [216] 0 0
Korea, Republic of
State/province [216] 0 0
Suwon-si
Country [217] 0 0
Korea, Republic of
State/province [217] 0 0
Wonju
Country [218] 0 0
Malaysia
State/province [218] 0 0
Cheras
Country [219] 0 0
Malaysia
State/province [219] 0 0
George Town
Country [220] 0 0
Malaysia
State/province [220] 0 0
Kota Kinabalu
Country [221] 0 0
Malaysia
State/province [221] 0 0
Kuala Lumpur
Country [222] 0 0
Malaysia
State/province [222] 0 0
Kuantan
Country [223] 0 0
Netherlands
State/province [223] 0 0
Alkmaar
Country [224] 0 0
Netherlands
State/province [224] 0 0
Amsterdam
Country [225] 0 0
Netherlands
State/province [225] 0 0
Apeldoorn
Country [226] 0 0
Netherlands
State/province [226] 0 0
Groningen
Country [227] 0 0
Netherlands
State/province [227] 0 0
Maastricht
Country [228] 0 0
Netherlands
State/province [228] 0 0
Rotterdam
Country [229] 0 0
Netherlands
State/province [229] 0 0
Tilburg
Country [230] 0 0
Netherlands
State/province [230] 0 0
Utrecht
Country [231] 0 0
New Zealand
State/province [231] 0 0
Christchurch
Country [232] 0 0
New Zealand
State/province [232] 0 0
Dunedin
Country [233] 0 0
New Zealand
State/province [233] 0 0
Grafton
Country [234] 0 0
New Zealand
State/province [234] 0 0
Hamilton
Country [235] 0 0
New Zealand
State/province [235] 0 0
Newtown
Country [236] 0 0
New Zealand
State/province [236] 0 0
Tauranga
Country [237] 0 0
New Zealand
State/province [237] 0 0
Wellington
Country [238] 0 0
Poland
State/province [238] 0 0
Bialystok
Country [239] 0 0
Poland
State/province [239] 0 0
Bydgoszcz
Country [240] 0 0
Poland
State/province [240] 0 0
Czestochowa
Country [241] 0 0
Poland
State/province [241] 0 0
Katowice
Country [242] 0 0
Poland
State/province [242] 0 0
Krakow
Country [243] 0 0
Poland
State/province [243] 0 0
Kraków
Country [244] 0 0
Poland
State/province [244] 0 0
Lodz
Country [245] 0 0
Poland
State/province [245] 0 0
Piotrków Trybunalski
Country [246] 0 0
Poland
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Poznan
Country [247] 0 0
Poland
State/province [247] 0 0
Rzeszów
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Poland
State/province [248] 0 0
Sopot
Country [249] 0 0
Poland
State/province [249] 0 0
Szczecin
Country [250] 0 0
Poland
State/province [250] 0 0
Torun
Country [251] 0 0
Poland
State/province [251] 0 0
Tychy
Country [252] 0 0
Poland
State/province [252] 0 0
Warsaw
Country [253] 0 0
Poland
State/province [253] 0 0
Warszawa
Country [254] 0 0
Poland
State/province [254] 0 0
Wroclaw
Country [255] 0 0
Portugal
State/province [255] 0 0
Braga
Country [256] 0 0
Portugal
State/province [256] 0 0
Coimbra
Country [257] 0 0
Portugal
State/province [257] 0 0
Covilhã
Country [258] 0 0
Portugal
State/province [258] 0 0
Faro
Country [259] 0 0
Portugal
State/province [259] 0 0
Guimaraes
Country [260] 0 0
Portugal
State/province [260] 0 0
Loures
Country [261] 0 0
Portugal
State/province [261] 0 0
Porto
Country [262] 0 0
Portugal
State/province [262] 0 0
Viana do Castelo
Country [263] 0 0
Romania
State/province [263] 0 0
Bucharest
Country [264] 0 0
Romania
State/province [264] 0 0
Bucuresti
Country [265] 0 0
Romania
State/province [265] 0 0
Iasi
Country [266] 0 0
Romania
State/province [266] 0 0
Timisoara
Country [267] 0 0
Russian Federation
State/province [267] 0 0
Chelyabinsk
Country [268] 0 0
Russian Federation
State/province [268] 0 0
Irkutsk
Country [269] 0 0
Russian Federation
State/province [269] 0 0
Moscow
Country [270] 0 0
Russian Federation
State/province [270] 0 0
Nizhniy Novgorod
Country [271] 0 0
Russian Federation
State/province [271] 0 0
Novosibirsk
Country [272] 0 0
Russian Federation
State/province [272] 0 0
Saint-Petersburg
Country [273] 0 0
Russian Federation
State/province [273] 0 0
Saratov
Country [274] 0 0
Serbia
State/province [274] 0 0
Belgrade
Country [275] 0 0
Serbia
State/province [275] 0 0
Novi Sad
Country [276] 0 0
Singapore
State/province [276] 0 0
Singapore
Country [277] 0 0
Slovakia
State/province [277] 0 0
Bratislava
Country [278] 0 0
Slovakia
State/province [278] 0 0
Nitra
Country [279] 0 0
Slovakia
State/province [279] 0 0
Presov
Country [280] 0 0
South Africa
State/province [280] 0 0
Cape Town
Country [281] 0 0
South Africa
State/province [281] 0 0
Johannesburg
Country [282] 0 0
Spain
State/province [282] 0 0
Badalona
Country [283] 0 0
Spain
State/province [283] 0 0
Barcelona
Country [284] 0 0
Spain
State/province [284] 0 0
Ferrol
Country [285] 0 0
Spain
State/province [285] 0 0
Las Palmas de Gran Canaria
Country [286] 0 0
Spain
State/province [286] 0 0
Madrid
Country [287] 0 0
Spain
State/province [287] 0 0
Oviedo
Country [288] 0 0
Spain
State/province [288] 0 0
Pontevedra
Country [289] 0 0
Spain
State/province [289] 0 0
Sagunto
Country [290] 0 0
Spain
State/province [290] 0 0
Sevilla
Country [291] 0 0
Spain
State/province [291] 0 0
Usansolo
Country [292] 0 0
Sri Lanka
State/province [292] 0 0
Colombo
Country [293] 0 0
Sri Lanka
State/province [293] 0 0
Galle
Country [294] 0 0
Sri Lanka
State/province [294] 0 0
Kandy
Country [295] 0 0
Sri Lanka
State/province [295] 0 0
Ragama
Country [296] 0 0
Sweden
State/province [296] 0 0
Danderyd
Country [297] 0 0
Sweden
State/province [297] 0 0
Uppsala
Country [298] 0 0
Switzerland
State/province [298] 0 0
Bern
Country [299] 0 0
Switzerland
State/province [299] 0 0
Zurich
Country [300] 0 0
Taiwan
State/province [300] 0 0
Changhua
Country [301] 0 0
Taiwan
State/province [301] 0 0
Kaohsiung
Country [302] 0 0
Taiwan
State/province [302] 0 0
New Taipei City
Country [303] 0 0
Taiwan
State/province [303] 0 0
Taichung
Country [304] 0 0
Taiwan
State/province [304] 0 0
Tainan City
Country [305] 0 0
Taiwan
State/province [305] 0 0
Taipei
Country [306] 0 0
Taiwan
State/province [306] 0 0
Taoyuan
Country [307] 0 0
Ukraine
State/province [307] 0 0
Chernivtsi
Country [308] 0 0
Ukraine
State/province [308] 0 0
Dnipropetrovsk
Country [309] 0 0
Ukraine
State/province [309] 0 0
Ivano-Frankivsk
Country [310] 0 0
Ukraine
State/province [310] 0 0
Kharkiv
Country [311] 0 0
Ukraine
State/province [311] 0 0
Kropyvnytskyi
Country [312] 0 0
Ukraine
State/province [312] 0 0
Kyiv
Country [313] 0 0
Ukraine
State/province [313] 0 0
Odessa
Country [314] 0 0
Ukraine
State/province [314] 0 0
Ternopil
Country [315] 0 0
Ukraine
State/province [315] 0 0
Uzhgorod
Country [316] 0 0
Ukraine
State/province [316] 0 0
Vinnytsia
Country [317] 0 0
Ukraine
State/province [317] 0 0
Zaporizhzhya
Country [318] 0 0
United Kingdom
State/province [318] 0 0
Norfolk
Country [319] 0 0
United Kingdom
State/province [319] 0 0
Birmingham
Country [320] 0 0
United Kingdom
State/province [320] 0 0
Bury
Country [321] 0 0
United Kingdom
State/province [321] 0 0
Cambridge
Country [322] 0 0
United Kingdom
State/province [322] 0 0
Edinburgh
Country [323] 0 0
United Kingdom
State/province [323] 0 0
Exeter
Country [324] 0 0
United Kingdom
State/province [324] 0 0
Glasgow
Country [325] 0 0
United Kingdom
State/province [325] 0 0
High Wycombe
Country [326] 0 0
United Kingdom
State/province [326] 0 0
London
Country [327] 0 0
United Kingdom
State/province [327] 0 0
Oxford
Country [328] 0 0
United Kingdom
State/province [328] 0 0
Prescot
Country [329] 0 0
United Kingdom
State/province [329] 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/NCT02914600