Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis
2 other identifiers
interventional
165
23 countries
87
Brief Summary
The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2015
Shorter than P25 for phase_2
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
April 10, 2019
CompletedApril 10, 2019
March 1, 2019
1 year
August 7, 2015
March 18, 2019
March 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8
EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).
Week 8
Secondary Outcomes (6)
For Cohort 1, Percentage of Participants With MCS Remission at Week 8
Week 8
For Cohort 1, Percentage of Participants With MCS Response at Week 8
Week 8
For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8
Week 8
For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8
Week 8
For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8
Week 8
- +1 more secondary outcomes
Study Arms (3)
Andecaliximab Every 2 Weeks
EXPERIMENTALParticipants 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 Weekly
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Andecaliximab 150 mg administered via SC injection
Placebo matched to andecaliximab administered via SC injection
Eligibility Criteria
You may qualify if:
- Ulcerative Colitis (UC) confirmed on endoscopy
- 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
You may not qualify if:
- Diagnose of Crohn's disease or indeterminate colitis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (87)
Unknown Facility
Dothan, Alabama, United States
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Wheat Ridge, Colorado, United States
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Lauderdale Lakes, Florida, United States
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Miramar, Florida, United States
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Winter Park, Florida, United States
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Zephyrhills, Florida, United States
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Chicago, Illinois, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Monroe, Louisiana, United States
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Ann Arbor, Michigan, United States
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Plymouth, Minnesota, United States
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St Louis, Missouri, United States
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Egg Harbor, New Jersey, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Mentor, Ohio, United States
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Rochester, Ohio, United States
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Germantown, Tennessee, United States
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Hermitage, Tennessee, United States
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Arlington, Texas, United States
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Baytown, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Charlottesville, Virginia, United States
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Chesapeake, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Wauwatosa, Wisconsin, United States
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Footscray, Australia
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Herston, Australia
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Malvern, Australia
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Melbourne, Australia
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Ghent, Belgium
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Leuven, Belgium
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Mouscron, Belgium
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Pleven, Bulgaria
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Victoria, British Columbia, Canada
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Vaughan, Ontario, Canada
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Hradec Králové, Czechia
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Nantes, France
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Békéscsaba, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Dublin, Leinster, Ireland
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Rozzano, Italy
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San Giovanni Rotondo, Italy
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Daugavpils, Latvia
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Amsterdam, Netherlands
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Christchurch, Canterbury, New Zealand
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Auckland, New Zealand
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Wellington, New Zealand
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Bialystok, Poland
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Krakow, Poland
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Lublin, Poland
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Piaseczno, Poland
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Poznan, Poland
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Sopot, Poland
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Środa Wielkopolska, Poland
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Tychy, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Bucharest, Romania
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Timișoara, Romania
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Moscow, Russia
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Novosibirsk, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Trenčín, Slovakia
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Claremont, Western Cape, South Africa
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Seoul, South Korea
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Suwon, South Korea
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Basel, Switzerland
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Bern, Switzerland
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Taichung, Taiwan
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Vinnitsa, Ukraine
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Cambridge, United Kingdom
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Oxford, United Kingdom
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Prescot, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to early termination of the study, Week 52 data were not available, and therefore prespecified Week 52 analyses could not be conducted.
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2015
First Posted
August 11, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2016
Study Completion
November 1, 2016
Last Updated
April 10, 2019
Results First Posted
April 10, 2019
Record last verified: 2019-03