Small Bowel Crohn's DiseasePhase 2DIVERGENCE 1NCT03046056
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
A Phase 2 study testing Filgotinib in people with Small Bowel Crohn's Disease, run by Gilead Sciences at 38 sites in 12 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Bowel Crohn's Disease
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 38 sitesin 12 countries
- Study dates
- 11 Apr 2017to 20 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
- Moderately or severely active CD
- Minimum duration of CD of at least 6 months
- Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
- Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
- 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):
Show all 12Show fewer
- Corticosteroids
- Immunomodulators
- Tumor necrosis factor-alpha (TNFα) antagonists
- Vedolizumab
- Ustekinumab
- Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements
Who cannot join
- Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
- Presence of fistulae
- Evidence of short bowel syndrome
- Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
- History of total colectomy, subtotal-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.
Trial locations and contacts
38 sites in 12 countries.
38 sites in 12 countries
United States15 sites
Texas Clinical Research Institute
Arlington, Texas, 76012
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047
Gastro Center of Maryland
Columbia, Maryland, 21045
Fargo Gastroenterology and Hepatology Clinic
Fargo, North Dakota, 58103
Gastro One
Germantown, Tennessee, 38138
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Miami Crohn's and Colitis Center
Miami, Florida, 33136
Center for lnterventional Endoscopy- Florida Hospital
Orlando, Florida, 32804
McGuire DVAMC
Richmond, Virginia, 23249
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
TDDC San Marcos
San Marcos, Texas, 78666
Texas Digestive Disease Consultants
Southlake, Texas, 76092
University of South Florida South Tampa campus
Tampa, Florida, 33606
United Kingdom4 sites
Royal Devon and Exeter Hospital, Department of Gastroenterology
Exeter, EX2 5DW
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
St Georges Clinical Research Facility
London, SW17 0QT
John Radcliffe Hospital
Oxford, OX3 9DU
Ukraine3 sites
Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University
Ivano-Frankivsk, 76018
Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1
Kharkiv, 61137
Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology
Ternopil, 46002
Austria2 sites
Medical University of Innsbruck, Department of Internal Medicine I
Innsbruck, 6020
Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
Vienna, 1090
Belgium2 sites
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Centre Hospitalier Chretien
Liège, 4000
Canada2 sites
Mount Sinai Hospital
Toronto, M5T 3L9
PerCuro Clinical Research Ltd.
Victoria, V8V 3M9
Germany2 sites
Gastroenterologie, Hepatologie und Endokrinologie
Hanover, 30625
Universitatsklinikum Jena
Jena, 07747
Hungary2 sites
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza
Békéscsaba, 5600
Bugát Pál Kórház, Gasztroenterológiai osztály
Gyöngyös, Heves County, 3200
Italy2 sites
Azienda Ospedaliero - Universitaria Mater Domini
Catanzaro, 88100
Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma
Rome, 00128
Spain2 sites
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Universitario Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35016
France1 site
CHU de Toulouse -Hopital Rangueil (Main Office)
Toulouse, Midi-Pyrenees, 31059
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.
- Conditions
- Small Bowel Crohn's Disease
- Being tested
- Filgotinib, Placebo to match filgotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Also called GS-6034, GLPG0634
Tablet(s) administered orally once daily
Placebo to match filgotinibDrug
Tablet(s) administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib 200 mg | Experimental | Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks. Receives: Drug: Filgotinib; Drug: Placebo to match filgotinib |
| Filgotinib 100 mg | Experimental | Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks. Receives: Drug: Filgotinib; Drug: Placebo to match filgotinib |
| Placebo | Placebo comparator | PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks. Receives: Drug: Placebo to match filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Clinical Remission at Week 24
The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of < 150. A higher score indicates more severe disease.
Measured: Week 24
Secondary outcomes (14)
Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24
Magnetic resonance enterography (MRE) is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and relative contrast enhancement (RCE). A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these components for the terminal ileum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening.
Measured: Baseline; Week 24
Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24
MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system. The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement and a positive change from baseline indicates disease worsening.
Measured: Baseline; Week 24
Change From Baseline in Jejunum Segmental MaRIA Score at Week 24
MRE is an imaging technique to evaluate disease activity in CD. MaRIA is an MRE-based scoring system.The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at Screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer. Segmental scores less than 7 indicate remission in that segment. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A positive change from baseline indicates disease worsening.
Measured: Baseline; Week 24
Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in terminal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.
Measured: Week 24
Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in distal ileum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.
Measured: Week 24
Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA remission was defined as a segmental MaRIA score < 7 in jejunum segment at Week 24 among participants with MaRIA score ≥ 7 in the same segment at baseline. A segmental score of ≥ 7 indicates active inflammation and a score of ≥ 11 indicates the presence of an ulcer.
Measured: Week 24
Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the terminal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ minimum detectable difference (MDD) units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the terminal ileum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.
Measured: Week 24
Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the distal ileum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score≥ 7 in the distal ileum. For segments with baseline MaRIA score ≥ 15, the minimum detectable difference (MDD) is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.
Measured: Week 24
Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for the jejunum segment of the small bowel. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. MaRIA response was defined as a segmental MaRIA score < 11 with baseline score ≥ 11, or a segmental MaRIA score < 7 with baseline score < 11, or ≥ MDD units decrease from baseline score for segments with baseline MaRIA score ≥ 7 in the jejunum. For segments with baseline MaRIA score ≥ 15, the MDD is 6.5 units and for baseline MaRIA score < 15, the MDD is 4.0 units.
Measured: Week 24
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Small bowel MaRIA remission was defined as MaRIA score < 7 at Week 24 in each of the 3 small bowel segments, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline.
Measured: Week 24
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24
The MaRIA scoring system is a composite index of 4 components. These components are edema, ulcers, gut wall thickness, and RCE. A segmental MaRIA score can be calculated at screening (used as the baseline) and Week 24 as a weighted sum of these 4 components for each of the 3 small bowel segments. The MaRIA score ranges from approximately 0 to 31, for any given segment. A higher score indicates more severe disease. Participant level small bowel MaRIA response was defined as all small bowel segments with baseline MaRIA score ≥7 achieve segment level MaRIA response, with no segment level disease worsening in any other segment(s) at Week 24, among participants with MaRIA score ≥ 7 in at least 1 small bowel segment at baseline.
Measured: Week 24
Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of < 150. A higher score indicates more severe disease.
Measured: Week 10
Change From Baseline in CDAI Scores at Week 10
The CDAI score is used to quantify the symptoms of participants with CD. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease. Difference in least squared means (Diff in LSM) were from analysis of covariance (ANCOVA) model. A negative change from baseline indicates improvement.
Measured: Baseline; Week 10
Change From Baseline in CDAI Scores at Week 24
The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The score ranges from 0 to 600. A score of < 150 indicates remission. A higher score indicates more severe disease. Diff in LSM were from ANCOVA model. A negative change from baseline indicates improvement.
Measured: Baseline; Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start11 Apr 2017
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lakefront Biotherapeutics NV
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046056
- Sponsor's protocol ID
- GS-US-419-4015
- Other IDs
- 2016-003179-23, 2016
- Acronym
- DIVERGENCE 1
- Status last verified
- Aug 2021
- First submitted
- 6 Feb 2017
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riviere P, D'Haens G, Peyrin-Biroulet L, Baert F, Lambrecht G, Pariente B, Bossuyt P, Buisson A, Oldenburg B, Vermeire S, Laharie D. Location but Not Severity of Endoscopic Lesions Influences Endoscopic Remission Rates in Crohn's Disease: A Post Hoc Analysis of TAILORIX. Am J Gastroenterol. 2021 Jan 1;116(1):134-141. doi: 10.14309/ajg.0000000000000834.
PubMed 33177349
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
- ClinicalTrials.gov ID
- NCT03046056
- Acronym / sponsor ID
- DIVERGENCE 1 / GS-US-419-4015
- Conditions
- Small Bowel Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Lakefront Biotherapeutics NV
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Posted 9 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Filgotinib 200 mg | Experimental | Drug: Filgotinib, Drug: Placebo to match filgotinibFilgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks. |
| Filgotinib 100 mg | Experimental | Drug: Filgotinib, Drug: Placebo to match filgotinibFilgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks. |
| Placebo | Placebo comparator | Drug: Placebo to match filgotinibPTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
- Moderately or severely active CD
- Minimum duration of CD of at least 6 months
- Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
- Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
Key exclusion criteria (8 listed)
- Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
- Presence of fistulae
- Evidence of short bowel syndrome
- Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
- History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibAlso: GS-6034, GLPG0634Tablet(s) administered orally once daily | Drug | Filgotinib 100 mg, Filgotinib 200 mg |
| Placebo to match filgotinibTablet(s) administered orally once daily | Drug | Filgotinib 100 mg, Filgotinib 200 mg, Placebo |
Primary outcome
Percentage of Participants Who Achieved Clinical Remission at Week 24
Time frame: Week 24
The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of < 150. A higher score indicates more severe disease.
14 secondary outcomes
Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24
Time frame: Baseline; Week 24
Change From Baseline in Jejunum Segmental MaRIA Score at Week 24
Time frame: Baseline; Week 24
Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24
Time frame: Week 24
Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24
Time frame: Week 24
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24
Time frame: Week 24
Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24
Time frame: Week 24
Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
Time frame: Week 10
Change From Baseline in CDAI Scores at Week 10
Time frame: Baseline; Week 10
Change From Baseline in CDAI Scores at Week 24
Time frame: Baseline; Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33177349Riviere P, D'Haens G, Peyrin-Biroulet L, Baert F, Lambrecht G, Pariente B, Bossuyt P, Buisson A, Oldenburg B, Vermeire S, Laharie D. Location but Not Severity of Endoscopic Lesions Influences Endoscopic Remission Rates in Crohn's Disease: A Post Hoc Analysis of TAILORIX. Am J Gastroenterol. 2021 Jan 1;116(1):134-141. doi: 10.14309/ajg.0000000000000834.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
38 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgotinib in people with Small Bowel Crohn's Disease, run by Gilead Sciences at 38 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, United Kingdom, Ukraine, Austria, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved Clinical Remission at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.