Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/10/2019 |
Start Date: | October 31, 2016 |
End Date: | December 2019 |
Contact: | Gilead Clinical Study Information Center |
Email: | GileadClinicalTrials@gilead.com |
Phone: | 1-833-445-3230 (GILEAD-0) |
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
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 (Gilead
Study GS-US-419-3896).
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 (Gilead
Study GS-US-419-3896).
Key Inclusion Criteria:
- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
the date of the screening visit
- 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
- 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 (TNFa) antagonists, or vedolizumab
Key Exclusion Criteria:
- Current complications of CD such as symptomatic strictures, severe rectal/anal
stenosis, 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.
We found this trial at
94
sites
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112 Gainsborough Square
Chesapeake, Virginia 23320
Chesapeake, Virginia 23320
757-547-0798
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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550 1st Avenue
New York, New York 10016
New York, New York 10016
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601 East Rollins Street
Orlando, Florida 32803
Orlando, Florida 32803
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
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