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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/NCT02914561




Registration number
NCT02914561
Ethics application status
Date submitted
22/09/2016
Date registered
26/09/2016
Date last updated
18/12/2023

Titles & IDs
Public title
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Scientific title
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
2016-001367-36
Secondary ID [2] 0 0
GS-US-419-3895
Universal Trial Number (UTN)
Trial acronym
DIVERSITY1
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
Other interventions - Placebo

Experimental: Cohort A: Filgotinib 200 (mg) (Induction Study) - Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

Experimental: Cohort A: Filgotinib 100 mg (Induction Study) - Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.

Placebo Comparator: Cohort A: Placebo (Induction Study) - Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

Experimental: Cohort B: Filgotinib 200 mg (Induction Study) - Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

Experimental: Cohort B: Filgotinib 100 mg (Induction Study) - Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.

Placebo Comparator: Cohort B: Placebo (Induction Study) - Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.

Experimental: Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study) - Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.

Experimental: Filgotinib 200 mg to Placebo (Maintenance Study) - Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.

Experimental: Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study) - Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.

Experimental: Filgotinib 100 mg to Placebo (Maintenance Study) - Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.

Placebo Comparator: Placebo to Placebo (Maintenance Study) - Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.


Treatment: Drugs: Filgotinib
Filgotinib tablets administered orally once daily.

Other interventions: Placebo
Placebo administered orally once daily.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
Timepoint [1] 0 0
Week 10
Primary outcome [2] 0 0
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
Timepoint [2] 0 0
Week 10
Primary outcome [3] 0 0
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
Timepoint [3] 0 0
Week 58
Primary outcome [4] 0 0
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
Timepoint [4] 0 0
Week 58
Secondary outcome [1] 0 0
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
Timepoint [1] 0 0
Week 10
Secondary outcome [2] 0 0
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
Timepoint [2] 0 0
Week 10
Secondary outcome [3] 0 0
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
Timepoint [3] 0 0
Week 58
Secondary outcome [4] 0 0
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
Timepoint [4] 0 0
Week 58
Secondary outcome [5] 0 0
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
Timepoint [5] 0 0
Weeks 10 and 58
Secondary outcome [6] 0 0
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
Timepoint [6] 0 0
Week 58
Secondary outcome [7] 0 0
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
Timepoint [7] 0 0
Weeks 10 and 58
Secondary outcome [8] 0 0
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
Timepoint [8] 0 0
Week 58
Secondary outcome [9] 0 0
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
Timepoint [9] 0 0
Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
Secondary outcome [10] 0 0
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
Timepoint [10] 0 0
Week 10: Predose
Secondary outcome [11] 0 0
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
Timepoint [11] 0 0
Week 26: At any timepoint
Secondary outcome [12] 0 0
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
Timepoint [12] 0 0
Week 58: Pre-dose
Secondary outcome [13] 0 0
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
Timepoint [13] 0 0
Week 4: 0.5, 1, 2, and 3 hrs post dose
Secondary outcome [14] 0 0
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10
Timepoint [14] 0 0
Week 10: Predose
Secondary outcome [15] 0 0
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
Timepoint [15] 0 0
Week 26: At any timepoint
Secondary outcome [16] 0 0
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
Timepoint [16] 0 0
Week 58: Pre-dose

Eligibility
Key inclusion criteria
Key

- Documented diagnosis of CD with a minimum disease duration of 3 months with
involvement of the ileum and/or colon at a minimum, as determined by histopathology
and endoscopic assessment

- Moderately to severely active CD

- Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response,
loss of response to, or intolerance to at least 1 of the following agents (depending
on current country treatment recommendations/guidelines): corticosteroids and
immunomodulators

- Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical
response, loss of response to, or intolerance to at least 1 of the following agents
(depending on current country treatment recommendations/guidelines) or discontinuation
of use of at least one of the following agents for reasons other than inadequate
clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa)
antagonists, vedolizumab, and ustekinumab

- Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical
response, loss of response to, or intolerance to at least 1 of the following agents
(depending on current country treatment recommendations/guidelines): TNFa antagonists,
vedolizumab, and ustekinumab

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current complications of CD such as symptomatic strictures, severe rectal/anal
stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.

- Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant
colitis, or toxic mega-colon

- Active tuberculosis (TB) or history of latent TB that has not been treated

- Use of any prohibited concomitant medications as described in the study protocol

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 3
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
31/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/11/2022
Sample size
Target
Accrual to date
Final
1372
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
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [4] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [6] 0 0
Coastal Digestive Health - Mountain Creek
Recruitment hospital [7] 0 0
Coral Sea Clinical Research Institute (Mackay) - North Mackay
Recruitment hospital [8] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [11] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [12] 0 0
Emeritus Research - Camberwell
Recruitment hospital [13] 0 0
Footscray Hospital - Footscray
Recruitment hospital [14] 0 0
Austin Health - Heidelberg
Recruitment hospital [15] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [16] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [17] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4557 - Mountain Creek
Recruitment postcode(s) [7] 0 0
4740 - North Mackay
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5042 - Bedford Park
Recruitment postcode(s) [11] 0 0
5011 - Woodville South
Recruitment postcode(s) [12] 0 0
3124 - Camberwell
Recruitment postcode(s) [13] 0 0
3011 - Footscray
Recruitment postcode(s) [14] 0 0
3084 - Heidelberg
Recruitment postcode(s) [15] 0 0
3144 - Malvern
Recruitment postcode(s) [16] 0 0
3004 - Melbourne
Recruitment postcode(s) [17] 0 0
3050 - Parkville
Recruitment outside Australia
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Surat
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Petah Tikva
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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 objectives of this study are to evaluate the safety and efficacy of filgotinib
during induction and maintenance treatment of moderately to severely active Crohn's disease
(CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria
at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study
GS-US-419-3896).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02914561
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/NCT02914561