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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/NCT02914600




Registration number
NCT02914600
Ethics application status
Date submitted
22/09/2016
Date registered
26/09/2016
Date last updated
14/08/2023

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
DIVERSITYLTE
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 (blinded dosing) - Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 390 weeks

Experimental: Filgotinib 100 mg (blinded dosing) - Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 390 weeks

Placebo Comparator: Placebo (blinded dosing) - Placebo to match filgotinib 200 mg for up to 390 weeks

Experimental: Filgotinib 200 mg (open-label) - Filgotinib 200 mg for up to 390 weeks

Experimental: Filgotinib 100 mg (open-label) - Filgotinib 100 mg for up to 390 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 the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
Timepoint [1] 0 0
Up to 390 weeks plus 30 days
Secondary outcome [1] 0 0
Change from Baseline in PRO2 Scores
Timepoint [1] 0 0
Baseline and up to 390 weeks
Secondary outcome [2] 0 0
Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores
Timepoint [2] 0 0
Baseline and up to 390 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 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

- Female subjects 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 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
Terminated
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
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Coral Sea Clinical Research Institute (Mackay) - North Mackay
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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
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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
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5011 - Woodville South
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3124 - Camberwell
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3168 - Clayton
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3011 - Footscray
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3084 - Heidelberg
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3144 - Malvern
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3004 - Melbourne
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3050 - Parkville
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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 Crohn's disease (CD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02914600
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/NCT02914600