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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
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
Secondary ID [1] 0 0
2016-003153-15
Secondary ID [2] 0 0
GS-US-419-4016
Universal Trial Number (UTN)
Trial acronym
Divergence2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fistulizing 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 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Combined Fistula Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Combined Fistula Remission at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Time to Clinical Fistula Response up to Week 24
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Time to Clinical Fistula Remission up to Week 24
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Proctitis Remission at Week 24
Timepoint [4] 0 0
Week 24

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

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

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 2
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
6/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2021
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Austria
State/province [8] 0 0
Klagenfurt
Country [9] 0 0
Austria
State/province [9] 0 0
Vienna
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Canada
State/province [11] 0 0
Toronto
Country [12] 0 0
France
State/province [12] 0 0
La Tronche
Country [13] 0 0
France
State/province [13] 0 0
RENNES Cedex 9
Country [14] 0 0
France
State/province [14] 0 0
Vandœuvre-lès-Nancy
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Jena
Country [17] 0 0
Hungary
State/province [17] 0 0
Bekes
Country [18] 0 0
Hungary
State/province [18] 0 0
Heves
Country [19] 0 0
Italy
State/province [19] 0 0
Rozzano
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Exeter

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03077412
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
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