Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT02520284
Last Updated: 2019-04-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
165 participants
INTERVENTIONAL
2015-09-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Andecaliximab Every 2 Weeks
Participants will receive andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.
Andecaliximab
Andecaliximab 150 mg administered via SC injection
Placebo
Placebo matched to andecaliximab administered via SC injection
Andecaliximab Weekly
Participants will receive andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.
Andecaliximab
Andecaliximab 150 mg administered via SC injection
Placebo
Participants will receive placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.
Andecaliximab
Andecaliximab 150 mg administered via SC injection
Placebo
Placebo matched to andecaliximab administered via SC injection
Interventions
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Andecaliximab
Andecaliximab 150 mg administered via SC injection
Placebo
Placebo matched to andecaliximab administered via SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active UC (Mayo Score 6-12)
* May be receiving oral 5-aminosalicylate (ASA), oral corticosteroid, azathioprine, 6-mercaptopurine (MP), or methotrexate
* Treatment failure with at least one of the following agents received: corticosteroids, immunomodulators, tumor necrosis factor-alpha (TNFα) antagonists, vedolizumab
Exclusion Criteria
* Pregnant or lactating females
* Any chronic medical condition (including, but not limited to cardiac or pulmonary disease, alcohol or drug abuse)
* Exhibit severe UC / clinically significant active infection
* History of malignancy in the last 5 years
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Dothan, Alabama, United States
Wheat Ridge, Colorado, United States
Lauderdale Lakes, Florida, United States
Miramar, Florida, United States
Winter Park, Florida, United States
Zephyrhills, Florida, United States
Chicago, Illinois, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Monroe, Louisiana, United States
Ann Arbor, Michigan, United States
Plymouth, Minnesota, United States
St Louis, Missouri, United States
Egg Harbor, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Mentor, Ohio, United States
Rochester, Ohio, United States
Germantown, Tennessee, United States
Hermitage, Tennessee, United States
Arlington, Texas, United States
Baytown, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Wauwatosa, Wisconsin, United States
Footscray, , Australia
Herston, , Australia
Malvern, , Australia
Melbourne, , Australia
Ghent, , Belgium
Leuven, , Belgium
Mouscron, , Belgium
Pleven, , Bulgaria
Victoria, British Columbia, Canada
Vaughan, Ontario, Canada
Hradec Králové, , Czechia
Nantes, , France
Békéscsaba, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Dublin, Leinster, Ireland
Rozzano, , Italy
San Giovanni Rotondo, , Italy
Daugavpils, , Latvia
Amsterdam, , Netherlands
Christchurch, Canterbury, New Zealand
Auckland, , New Zealand
Wellington, , New Zealand
Bialystok, , Poland
Krakow, , Poland
Lublin, , Poland
Piaseczno, , Poland
Poznan, , Poland
Sopot, , Poland
Środa Wielkopolska, , Poland
Tychy, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Timișoara, , Romania
Moscow, , Russia
Novosibirsk, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Trenčín, , Slovakia
Claremont, Western Cape, South Africa
Seoul, , South Korea
Suwon, , South Korea
Basel, , Switzerland
Bern, , Switzerland
Taichung, , Taiwan
Kharkiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Vinnitsa, , Ukraine
Cambridge, , United Kingdom
Oxford, , United Kingdom
Prescot, , United Kingdom
Countries
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Other Identifiers
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2014-005217-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-326-1100
Identifier Type: -
Identifier Source: org_study_id
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