Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT02520284. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02520284
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 165 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2015 (Actual)
- Primary completion
- Sep 2016 (Actual)
- Completion
- Nov 2016 (Actual)
- Last update posted
- Apr 10, 2019
2015 – 2016
United States locations
- U.S. sites
- 33
- U.S. states
- 19
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Dothan | Alabama | — | — |
| Not listed | Wheat Ridge | Colorado | — | — |
| Not listed | Lauderdale Lakes | Florida | — | — |
| Not listed | Miramar | Florida | — | — |
| Not listed | Winter Park | Florida | — | — |
| Not listed | Zephyrhills | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Topeka | Kansas | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | Monroe | Louisiana | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Plymouth | Minnesota | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Egg Harbor | New Jersey | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Mentor | Ohio | — | — |
| Not listed | Rochester | Ohio | — | — |
| Not listed | Germantown | Tennessee | — | — |
| Not listed | Hermitage | Tennessee | — | — |
| Not listed | Arlington | Texas | — | — |
| Not listed | Baytown | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Irving | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Southlake | Texas | — | — |
| Not listed | Charlottesville | Virginia | — | — |
| Not listed | Chesapeake | Virginia | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Richmond | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Wauwatosa | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02520284, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 10, 2019 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02520284 live on ClinicalTrials.gov.