Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Condition(s) studied
Investigational drug(s) / intervention(s)
emvistegrast: Administered orally
Placebo-to-match emvistegrast: Administered orally
Study summary
The goal of this study is to learn if emvistegrast (formerly GS-1427) is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with emvistegrast with participants treated with placebo.
The primary objective of this study is to assess the efficacy of emvistegrast, compared with placebo control, in achieving clinical response at Week 12.
Eligibility
Primary outcome measure(s)
- Proportion of Participants Achieving Clinical Response at Week 12 — Week 12
Clinical response is defined as a decrease from baseline in the modified Mayo Clinic Score (mMCS) of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥ 1 from baseline or an absolute rectal bleeding subscore of 0 or 1. The mMCS is a scoring system for assessment of Ulcerative Colitis (UC) activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.
Trial sites (181)
| Facility | City | Region | Status |
|---|---|---|---|
| Onyx Clinical Research (Clinic Location) | Peoria | Arizona | |
| Om Research LLC | Camarillo | California | |
| VVCRD Research | Garden Grove | California | |
| 310 Clinical Research | Inglewood | California | |
| US San Diego Health System | La Jolla | California | |
| Om Research LLC | Lancaster | California | |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | |
| University Of California, Davis | Sacramento | California | |
| SDG Clinical Research, LLC | San Diego | California | |
| Acclaim Clinical Research | San Diego | California | |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | |
| Gastro Florida | Clearwater | Florida | |
| Best Quality Research, Inc | Hialeah | Florida | |
| United Research Institute LLC | Hialeah | Florida | |
| University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy | Miami | Florida | |
| Medical Professional Clinical Research Center, Inc. | Miami | Florida | |
| Blessed Health Care & Research, Inc | Miami | Florida | |
| Alliance Clinical Research of Tampa, LLC | New Port Richey | Florida | |
| Digestive and Liver Center of Florida, LLC | Orlando | Florida | |
| Clinical Research of Osceola | Orlando | Florida | |
| Encore Medical Research of Weston, LLC | Weston | Florida | |
| EBGS Clinical Research Center | Snellville | Georgia | |
| The University of Chicago Medical Center (Duchossois Center for Advanced Medicine) | Chicago | Illinois | |
| Onyx Clinical Research | Peoria | Illinois | |
| Robley Rex VA Medical Center | Louisville | Kentucky | |
| Louisiana Research Center, LLC | Shreveport | Louisiana | |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center. | Wyoming | Michigan | |
| Mayo Clinic | Rochester | Minnesota | |
| Gastroenterology Associates of North Mississippi | Oxford | Mississippi | |
| Digestive Health Specialists (Clinic Visits) | Tupelo | Mississippi | |
| St Charles Clinical Research | Weldon Spring | Missouri | |
| Tandem - Allied Clinical Research, LLC | Freehold | New Jersey | |
| N.Y. Total Medical Care, PC | Brooklyn | New York | |
| NYU Langone Long Island Clinical Research Associates | Great Neck | New York | |
| Lenox Hill Hospital | Manhasset | New York | |
| NYU Grossman School of Medicne | New York | New York | |
| Carolina Research | Greenville | North Carolina | |
| Piedmont Healthcare | Statesville | North Carolina |
+ 141 more sites — see the full list on the official registry below.
More Gilead Sciences trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06290934 on ClinicalTrials.gov ↗ ← All trials in Italy