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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02914535




Registration number
NCT02914535
Ethics application status
Date submitted
22/09/2016
Date registered
26/09/2016
Date last updated
27/11/2023

Titles & IDs
Public title
Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Scientific title
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
2016-002765-58
Secondary ID [2] 0 0
GS-US-418-3899
Universal Trial Number (UTN)
Trial acronym
SELECTIONLTE
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 - Placebo

Experimental: Filgotinib 200 mg (blinded dosing) - Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Experimental: Filgotinib 100 mg (blinded dosing) - Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks

Placebo Comparator: Placebo (blinded dosing) - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Experimental: Filgotinib 200 mg (open-label) - Filgotinib 200 mg for up to 336 weeks

Experimental: Filgotinib 100 mg (open-label) - Filgotinib 100 mg for up to 336 weeks


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

Treatment: Drugs: Placebo
Tablet(s) administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
Timepoint [1] 0 0
Up to 336 weeks plus 30 days
Secondary outcome [1] 0 0
Change From Baseline in Components of Mayo Clinic Score (MCS)
Timepoint [1] 0 0
Baseline and up to 336 weeks

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 Gilead-sponsored UC parent protocol GS US 418-3898 or any other
Gilead/Galapagos-sponsored filgotinib treatment study for UC

- Must have completed all required procedures or met protocol-specified efficacy
discontinuation criteria in a prior filgotinib treatment study for UC

- Females of childbearing potential must have a negative pregnancy test at Day 1

- Female individuals of childbearing potential who engage in heterosexual intercourse
must agree to use protocol specified method(s) of contraception for the duration
described

- Willingness to refrain from live or attenuated vaccines during the study and for 12
weeks after last dose of study drug

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 subject 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

- Use of prohibited medications as outlined in the 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
Accrual to date
Final
1173
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
Coastal Digestive Health - Mountain Creek
Recruitment hospital [5] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [8] 0 0
Footscray Hospital - Footscray
Recruitment hospital [9] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [10] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
4557 - Mountain Creek
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5011 - Woodville South
Recruitment postcode(s) [8] 0 0
3011 - Footscray
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
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Country [225] 0 0
Ukraine
State/province [225] 0 0
Kharkiv
Country [226] 0 0
Ukraine
State/province [226] 0 0
Kyiv
Country [227] 0 0
Ukraine
State/province [227] 0 0
Odessa
Country [228] 0 0
Ukraine
State/province [228] 0 0
Ternopil
Country [229] 0 0
Ukraine
State/province [229] 0 0
Vinnytsia
Country [230] 0 0
Ukraine
State/province [230] 0 0
Zaporizhzhya
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Norfolk
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Bury
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Cambridge
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Derby
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Edinburgh
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Glasgow
Country [237] 0 0
United Kingdom
State/province [237] 0 0
High Wycombe
Country [238] 0 0
United Kingdom
State/province [238] 0 0
London
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Nottingham
Country [240] 0 0
United Kingdom
State/province [240] 0 0
Oxford
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Prescot
Country [242] 0 0
United Kingdom
State/province [242] 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
The primary objective of this study is to observe the long-term safety of filgotinib in
adults who have completed or met protocol specified efficacy discontinuation criteria in a
prior filgotinib treatment study in ulcerative colitis (UC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02914535
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02914535