Clinical trial NCT03046056: Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Bowel Crohn's Disease
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2017-02-08
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.


Eligibility criteria: Key Inclusion Criteria:

* 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):

  * Corticosteroids
  * Immunomodulators
  * Tumor necrosis factor-alpha (TNFα) antagonists
  * Vedolizumab
  * Ustekinumab
* Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements

Key Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in Terminal Ileum Segmental Magnetic Resonance Index of Activity (MaRIA) Score at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in Distal Ileum Segmental MaRIA Score at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in Jejunum Segmental MaRIA Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Who Achieved MaRIA Remission in Terminal Ileum Segment at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved MaRIA Remission in Distal Ileum Segment at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved MaRIA Remission in Jejunum Segment at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved MaRIA Response in Terminal Ileum Segment at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved MaRIA Response in Distal Ileum Segment at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved MaRIA Response in Jejunum Segment at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Remission at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved Participant Level Small Bowel MaRIA Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved Early Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
timeFrame: Week 10
measure: Change From Baseline in CDAI Scores at Week 10
timeFrame: Baseline; Week 10
measure: Change From Baseline in CDAI Scores at Week 24
timeFrame: Baseline; Week 24
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
city: Orlando
country: United States
facility: Center for lnterventional Endoscopy- Florida Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida South Tampa campus
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Fargo
country: United States
facility: Fargo Gastroenterology and Hepatology Clinic
state: North Dakota
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: San Marcos
country: United States
facility: TDDC San Marcos
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, Department of Internal Medicine I
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Liège
country: Belgium
facility: Centre Hospitalier Chretien
city: Toronto
country: Canada
facility: Mount Sinai Hospital
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Toulouse Cedex 9
country: France
facility: CHU de Toulouse -Hopital Rangueil (Main Office)
state: Midi-Pyrenees
city: Hannover
country: Germany
facility: Gastroenterologie, Hepatologie und Endokrinologie
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Gyöngyös
country: Hungary
facility: Bugát Pál Kórház, Gasztroenterológiai osztály
state: Heves
city: Békéscsaba
country: Hungary
facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero - Universitaria Mater Domini
city: Rome
country: Italy
facility: Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Gran Canaria Dr. Negrin
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University
city: Kharkiv
country: Ukraine
facility: Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1
city: Ternopil
country: Ukraine
facility: Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Scotland
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital, Department of Gastroenterology
city: London
country: United Kingdom
facility: St Georges Clinical Research Facility
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.