ClinicalTrials.gov record
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT03290781
Public ClinicalTrials.gov record NCT03290781. 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 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Study identification
- NCT ID
- NCT03290781
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 366 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 81 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 3, 2018
- Primary completion
- Jun 30, 2021
- Completion
- Jun 30, 2021
- Last update posted
- Jan 13, 2022
2018 – 2021
United States locations
- U.S. sites
- 94
- U.S. states
- 28
- U.S. cities
- 83
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Digestive Health Mesa - East | Mesa | Arizona | 85206 | — |
| Elite Clinical Studies - Phoenix - Clinedge - PPDS | Phoenix | Arizona | 85018 | — |
| Atria Clinical Research - Clinedge - PPDS | Little Rock | Arkansas | 72209 | — |
| Advanced Research Center | Anaheim | California | 92805 | — |
| Kindred Medical Institute for Clinical Trials, LLC | Corona | California | 92879 | — |
| United Medical Doctors | Encinitas | California | 92024-1350 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster | California | 93534 | — |
| VA Long Beach Healthcare System - NAVREF - PPDS | Long Beach | California | 90822 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| United Medical Doctors | Murrieta | California | 92563 | — |
| Alliance Clinical Research-(Vestavia Hills) | Poway | California | 92064 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| Care Access Research, San Pablo | San Pablo | California | 94806 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80903 | — |
| Asthma and Allergy Associates PC - CRN - PPDS | Colorado Springs | Colorado | 80907 | — |
| Renaissance Research Medical Group, INC | Cape Coral | Florida | 33991 | — |
| Gastro Florida | Clearwater | Florida | 33756 | — |
| Advanced Clinical Research Network | Coral Gables | Florida | 33134 | — |
| Alliance Medical Research LLC | Coral Springs | Florida | 33071 | — |
| ENCORE Borland-Groover Clinical Research - ERN - PPDS | Jacksonville | Florida | 32256 | — |
| SIH Research | Kissimmee | Florida | 34741 | — |
| Hi Tech and Global Research, LLc | Miami | Florida | 33135 | — |
| Nuren Medical and Research Center | Miami | Florida | 33144 | — |
| Sanchez Clinical Research, Inc | Miami | Florida | 33157 | — |
| Crystal Biomedical Research | Miami Lakes | Florida | 33065 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Pharma Research International Inc | Naples | Florida | 34102 | — |
| Omega Research Consultants LLC - Clinedge - PPDS | Orlando | Florida | 32810 | — |
| Accel Research Sites - St. Petersburg - ERN - PPDS | Pinellas Park | Florida | 33781 | — |
| BRCR Medical Center, Inc | Plantation | Florida | 33322 | — |
| East Coast Institute for Research, LLC | Saint Augustine | Florida | 32086 | — |
| DBC Research | Tamarac | Florida | 33321 | — |
| Bayside Clinical Research - New Port Richey | Tampa | Florida | 33604 | — |
| Atlanta Gastroenterology Specialists, PC | Atlanta | Georgia | 30308 | — |
| Infinite Clinical Trials | Atlanta | Georgia | 30349 | — |
| Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS | Columbus | Georgia | 31904 | — |
| Atlanta Center For Gastroenterology PC | Decatur | Georgia | 30033 | — |
| Loretto Hospital | Chicago | Illinois | 60644 | — |
| IL Gastroenterology Group | Gurnee | Illinois | 60031 | — |
| Edward Hines Jr VA Hospital - NAVREF - PPDS | Hines | Illinois | 60141 | — |
| Dupage Medical Group | Oakbrook Terrace | Illinois | 60181 | — |
| Medisphere Medical Research Center LLC | Evansville | Indiana | 47714 | — |
| Laporte County Institute For Clinical Research | Michigan City | Indiana | 46360 | — |
| Gastroenterology Associates of Hazard | Hazard | Kentucky | 41701 | — |
| CroNOLA, LLC. | Houma | Louisiana | 70360 | — |
| Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | 70601 | — |
| Louisiana Research Center LLC | Shreveport | Louisiana | 71103 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Commonwealth Clinical Studies LLC | Brockton | Massachusetts | 02302 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan | Chesterfield | Michigan | 48047 | — |
| National Clinical, LLC | Hamtramck | Michigan | 48212 | — |
| Mayo Clinic Health System - PPDS | Duluth | Minnesota | 55805 | — |
| Digestive Health Center PA | Ocean Springs | Mississippi | 39564 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| St Louis Center For Clinical Research | St Louis | Missouri | 63128 | — |
| Advanced Biomedical Research of America | Las Vegas | Nevada | 89123 | — |
| Encompass Care | North Las Vegas | Nevada | 89086 | — |
| New York Total Medical Care PC | Brooklyn | New York | 11215 | — |
| NYU Langone Long Island Clinical Research Associates | Lake Success | New York | 11042 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Southtowns Gastroenterology, PLLC | Orchard Park | New York | 14127 | — |
| East Carolina Gastroenterology | Jacksonville | North Carolina | 28546 | — |
| Piedmont Healthcare | Statesville | North Carolina | 28625 | — |
| Consultants For Clinical Research Inc | Cincinnati | Ohio | 45219 | — |
| Consultants For Clinical Research Inc | Cincinnati | Ohio | 45249 | — |
| Consultants For Clinical Research Inc | Fairfield | Ohio | 45014 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Ohio Clinical Research Partners LLC | Mentor | Ohio | 44060 | — |
| Veteran's Research and Education Foundation - NAVREF - PPDS | Oklahoma City | Oklahoma | 73104 | — |
| Veterans Research Foundation of Pittsburgh - NAVREF - PPDS | Pittsburgh | Pennsylvania | 15240 | — |
| Digestive Disease Associates | Wyomissing | Pennsylvania | 19610 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Advanced Gastroenterology-Union City | Union City | Tennessee | 38237 | — |
| Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS | Baytown | Texas | 77521 | — |
| Northside Gastroenterology | Cypress | Texas | 77429 | — |
| Digestive Health Associates of Texas, P.A.dba DHAT Research Institute | Garland | Texas | 75044 | — |
| Precision Research Institute, LLC | Houston | Texas | 77039 | — |
| Biopharma Informatic Inc. | Houston | Texas | 77043 | — |
| Southwest Clinical Trials | Houston | Texas | 77074 | — |
| Aztec Medical Research | Houston | Texas | 77079 | — |
| BI Research Center | Houston | Texas | 77084 | — |
| Southern Star Research Institute LLC | San Antonio | Texas | 78229 | — |
| DM Clinical Research - ERN - PPDS | Tomball | Texas | 77375 | — |
| HP Clinical Research | Bountiful | Utah | 84010 | — |
| Mid Atlantic Health Specialists | Galax | Virginia | 24333 | — |
| Winchester Gastroenterology Associates | Winchester | Virginia | 22601-2872 | — |
| CHI Franciscan Digestive Care Associates | Tacoma | Washington | 98405 | — |
| Exemplar Research, Inc. - Elkins | Elkins | West Virginia | 26241 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | — |
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 307 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03290781, 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 Jan 13, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03290781 live on ClinicalTrials.gov.