Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Status: | Active, not recruiting |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/27/2019 |
Start Date: | November 14, 2016 |
End Date: | December 2019 |
Combined Phase 2b/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 Ulcerative Colitis
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in
the induction and maintenance treatment of moderately to severely active ulcerative colitis
(UC) 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-418-3899).
the induction and maintenance treatment of moderately to severely active ulcerative colitis
(UC) 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-418-3899).
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 UC of at least 6 months AND with a minimum disease extent of
15 cm from the anal verge. Documentation should include endoscopic and histopathologic
evidence of UC.
- A surveillance colonoscopy is required at screening in individuals with a history of
UC for 8 or more years, if one was not performed in the prior 24 months
- Moderately to severely active UC
- 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:
- Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant
colitis, ulcerative proctitis, or toxic mega-colon
- Active tuberculosis (TB) or history of latent TB that has not been treated
- Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
83
sites
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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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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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 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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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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