Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
Public ClinicalTrials.gov record NCT02405442. 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 Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.
Study identification
- NCT ID
- NCT02405442
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 187 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
- Apr 30, 2015 (Actual)
- Primary completion
- Nov 30, 2016 (Actual)
- Completion
- Dec 22, 2016 (Actual)
- Last update posted
- Apr 23, 2019
2015 – 2016
United States locations
- U.S. sites
- 33
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of The Southeast | Dothan | Alabama | — | — |
| Mayo Clinic | Scottsdale | Arizona | — | — |
| Cedars Sinai Medical Center | Los Angeles | California | — | — |
| South Denver Gastroenterology | Lone Tree | Colorado | — | — |
| University of Miami | Miami | Florida | — | — |
| Gastroenterology Group Of Naples | Naples | Florida | — | — |
| Gastroenterology Associates Of Central Georgia, LLC | Macon | Georgia | — | — |
| Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital | Indianapolis | Indiana | — | — |
| Iowa Digestive Disease Center | Clive | Iowa | — | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | — | — |
| Delta Research Partners | Monroe | Louisiana | — | — |
| Louisiana Research Center | Shreveport | Louisiana | — | — |
| University of Michigan | Ann Arbor | Michigan | — | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | — | — |
| Mayo Clinic Rochester | Rochester | Minnesota | — | — |
| Washington University School of Medicine | St Louis | Missouri | — | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | — | — |
| AGA Clinical Research Associates, LLC | Egg Harbor | New Jersey | — | — |
| Columbia University Medical Center/ New York Presbyterian | New York | New York | — | — |
| Premier Medical Group Of The Hudson Valley | Poughkeepsie | New York | — | — |
| Mayo Clinic Rochester | Rochester | New York | — | — |
| Asheville Gastroenterology Associates | Asheville | North Carolina | — | — |
| Consultants For Clinical Research | Cincinnati | Ohio | — | — |
| Great Lakes Gastroenterology | Mentor | Ohio | — | — |
| Gastro One | Germantown | Tennessee | — | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | — | — |
| Texas Clinical Research Institute | Arlington | Texas | — | — |
| Ertan Digestive Disease Center of Excellence, UTH/MH-TMC | Houston | Texas | — | — |
| Gastroenterology Research of San Antonio | San Antonio | Texas | — | — |
| Gastroenterology Associates Of Tidewater | Chesapeake | Virginia | — | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | — | — |
| Mcguire Dvamc | Richmond | Virginia | — | — |
| University of Washington Medical Center | Seattle | Washington | — | — |
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 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02405442, 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 23, 2019 · Synced Oct 21, 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 NCT02405442 live on ClinicalTrials.gov.