Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
Public ClinicalTrials.gov record NCT03627091. 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 Crohn's Disease (CARMEN CD 307)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).
Study identification
- NCT ID
- NCT03627091
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 80 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
- Feb 6, 2019 (Actual)
- Primary completion
- Jun 21, 2021 (Actual)
- Completion
- Sep 13, 2021 (Actual)
- Last update posted
- Mar 31, 2022
2019 – 2021
United States locations
- U.S. sites
- 73
- U.S. states
- 24
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Digestive Health Mesa - East | Mesa | Arizona | 85206 | — |
| Elite Clinical Studies - Phoenix - Clinedge - PPDS | Phoenix | Arizona | 85018 | — |
| CATS Research Center - University of Arizona | Tucson | Arizona | 85724 | — |
| 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 | — |
| OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster | California | 93534 | — |
| Alliance Clinical Research-(Vestavia Hills) | Poway | California | 92064 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| 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 | — |
| SIH Research | Kissimmee | Florida | 34741 | — |
| Hi Tech and Global Research, LLc | Miami | Florida | 33135 | — |
| 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 | 34110 | — |
| Omega Research Consultants LLC - Clinedge - PPDS | Orlando | Florida | 32810 | — |
| Accel Research Sites - St. Petersburg - ERN - PPDS | Pinellas Park | Florida | 33781 | — |
| 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 | — |
| Atlanta Center For Gastroenterology PC | Decatur | Georgia | 30033 | — |
| Loretto Hospital | Chicago | Illinois | 60644 | — |
| IL Gastroenterology Group | Gurnee | Illinois | 60031 | — |
| Laporte County Institute For Clinical Research | Michigan City | Indiana | 46360 | — |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| Gastroenterology Associates of Hazard | Hazard | Kentucky | 41701 | — |
| CroNOLA, LLC. | Houma | Louisiana | 70360 | — |
| Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | 70601 | — |
| DelRicht Clinical Research, LLC - ClinEdge - PPDS | New Orleans | Louisiana | 70115 | — |
| Louisiana Research Center LLC | Shreveport | Louisiana | 71103 | — |
| Commonwealth Clinical Studies LLC | Brockton | Massachusetts | 02302 | — |
| Winchester Gastroenterology Associates | Winchester | Massachusetts | 22601 | — |
| 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 | — |
| Gastroenterology Associates of Western Michigan, PLC | Wyoming | Michigan | 49519 | — |
| Mayo Clinic Health System - PPDS | Duluth | Minnesota | 55805 | — |
| Minnesota Gastroenterology PA | Saint Paul | Minnesota | 55114 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| 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 | Great Neck | New York | 11021 | — |
| Southtowns Gastroenterology, PLLC | Orchard Park | New York | 14127 | — |
| 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 | — |
| Penn State Hershey Medical Group | State College | Pennsylvania | 16803 | — |
| 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 | 38261 | — |
| 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 | — |
| BI Research Center | Houston | Texas | 77084 | — |
| Southern Star Research Institute LLC | San Antonio | Texas | 78229 | — |
| Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS | Webster | Texas | 77598 | — |
| HP Clinical Research | Bountiful | Utah | 84010 | — |
| Mid Atlantic Health Specialists | Galax | Virginia | 24333 | — |
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 208 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03627091, 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 Mar 31, 2022 · Synced Oct 27, 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 NCT03627091 live on ClinicalTrials.gov.