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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/NCT03077412
Registration number
NCT03077412
Ethics application status
Date submitted
8/03/2017
Date registered
13/03/2017
Date last updated
8/04/2022
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
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Scientific title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
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Secondary ID [1]
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2016-003153-15
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Secondary ID [2]
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GS-US-419-4016
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Universal Trial Number (UTN)
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Trial acronym
Divergence2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fistulizing Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib
Experimental: Filgotinib 200 mg - Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
Experimental: Filgotinib 100 mg - Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks
Experimental: Placebo - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
Treatment: Drugs: Filgotinib
Tablet(s) administered orally once daily
Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved Combined Fistula Response at Week 24
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Assessment method [1]
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Combined fistula response at Week 24 was defined as reduction of greater than or equal to (=) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections > 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Percentage of Participants Who Achieved Combined Fistula Remission at Week 24
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Assessment method [1]
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Combined fistula remission at Week 24 was defined as perianal fistula closure of all external openings that were draining at baseline, and absence of fluid collections > 1 cm on MRI of pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Time to Clinical Fistula Response up to Week 24
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Assessment method [2]
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Time to clinical fistula response was defined as the time interval in days from date of first dosing of study drug to the first observation (during scheduled or unscheduled clinical visits) when = 1 of the draining external perianal fistula openings that were present at baseline achieves perianal fistula closure, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula response were to have their clinical fistula response time censored at the last time that lack of clinical fistula response was documented.
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Timepoint [2]
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Time from treatment start to first visit when = 1 of the draining external perianal fistula openings that were present at baseline achieved perianal fistula closure up to Week 24
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Secondary outcome [3]
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Time to Clinical Fistula Remission up to Week 24
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Assessment method [3]
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Time to clinical fistula remission was defined as the time interval in days from date of first dosing of study drug to the first observation (during schedule or unscheduled clinical visits) of perianal fistula closure of all external openings that were draining at baseline, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula remission were have their clinical fistula remission time censored at the last time that lack of clinical fistula remission was documented.
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Timepoint [3]
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Time from treatment start to first visit when perianal fistula closure takes place of all external openings that were draining at baseline up to Week 24
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Secondary outcome [4]
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Percentage of Participants Who Achieved Proctitis Remission at Week 24
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Assessment method [4]
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The simple endoscopic score for Crohn's disease (SES-CD) score evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and presence of narrowings). The total SES-CD is calculated as the sum of the 4 variables for the required bowel segment. Values are given to each variable and for every examined bowel segment. The SES-CD size of ulcer subscore ranges from 0 (none) to 3 (very large) and for ulcerated surface subscore ranges from 0 (none) to 3 (>30 % of affected area). Higher value of the subscore indicates disease worsening. Proctitis remission at Week 24 was defined as a proctitis SES-CD score (sum of ulcer size and ulcerated surface SES-CD endoscopy subscores for the rectum and anal canal) of 0 assessed by centrally read flexible sigmoidoscopy at Week 24, in participants that had moderately to severely active proctitis at baseline. Moderately to Severely Active Proctitis defined as proctitis SES-CD Score > 2.
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Timepoint [4]
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Week 24
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Eligibility
Key inclusion criteria
Key
- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
the date of screening visit
- Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
- Has draining perianal fistulae as a complication of CD, confirmed by magnetic
resonance imaging (MRI) at screening
- Previously demonstrated an inadequate clinical response, loss of response to, or
intolerance of at least 1 of the following agents (depending on current country
treatment recommendations/guidelines):
- Antibiotics AND/OR
- Immunomodulators AND/OR
- Tumor necrosis factor a (TNFa) Antagonist
- Is willing and able to undergo MRI per protocol requirements
- Is willing and able to undergo flexible sigmoidoscopy per protocol requirements
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Presence of current rectovaginal anovaginal or enterovesicular fistulae
- Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis,
fulminant colitis, or toxic mega-colon
- History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy,
or likely requirement for surgery during the study
- Use of any prohibited concomitant medications as described in the study protocol
- Active tuberculosis (TB) or history of latent TB that has not been treated
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/02/2021
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Sample size
Target
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Accrual to date
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Final
57
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Florida
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Illinois
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Kentucky
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Maryland
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Austria
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Klagenfurt
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Austria
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Vienna
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Belgium
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Leuven
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Canada
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Toronto
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France
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La Tronche
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France
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RENNES Cedex 9
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France
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VandÅ“uvre-lès-Nancy
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Germany
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Dresden
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Germany
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Jena
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Hungary
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Bekes
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Hungary
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Heves
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Italy
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Rozzano
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United Kingdom
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Exeter
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Galapagos NV
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to evaluate the efficacy of filgotinib as compared to
placebo in establishing combined fistula response at Week 24. Participants will have the
option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if
they meet eligibility requirements.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03077412
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03077412
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