Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
Public ClinicalTrials.gov record NCT03566823. 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.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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 Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)
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 in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
Study identification
- NCT ID
- NCT03566823
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 34 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
- Jul 17, 2018 (Actual)
- Primary completion
- Aug 18, 2020 (Actual)
- Completion
- Aug 18, 2020 (Actual)
- Last update posted
- May 11, 2021
2018 – 2020
United States locations
- U.S. sites
- 48
- U.S. states
- 17
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Digestive Health Mesa - East | Mesa | Arizona | 85206 | — |
| Elite Clinical Studies - Phoenix - Clinedge - PPDS | Phoenix | Arizona | 85018 | — |
| Advanced Research Center | Anaheim | California | 92805 | — |
| Kindred Medical Institute for Clinical Trials, LLC | Corona | California | 92879 | — |
| Alliance Clinical Research-(Vestavia Hills) | Poway | California | 92064 | — |
| Care Access Research, San Pablo | San Pablo | California | 94806 | — |
| Renaissance Research Medical Group, INC | Cape Coral | Florida | 33991 | — |
| Gastro Florida | Clearwater | Florida | 33756 | — |
| 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 | — |
| Pharma Research International Inc | Naples | Florida | 34110 | — |
| Bayside Clinical Research - New Port Richey | New Port Richey | Florida | 34655 | — |
| Accel Research Sites - St. Petersburg - ERN - PPDS | Pinellas Park | Florida | 33781 | — |
| DBC Research | Tamarac | Florida | 33321 | — |
| Infinite Clinical Trials | Atlanta | Georgia | 30349 | — |
| Atlanta Center For Gastroenterology PC | Decatur | Georgia | 30033 | — |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | — |
| Loretto Hospital | Chicago | Illinois | 60644 | — |
| IL Gastroenterology Group | Gurnee | Illinois | 60031 | — |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| Gastroenterology Associates of Hazard | Hazard | Kentucky | 41701 | — |
| CroNOLA, LLC. | Houma | Louisiana | 70360 | — |
| DelRicht Clinical Research, LLC - ClinEdge - PPDS | New Orleans | Louisiana | 70115 | — |
| 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 | Plymouth | Minnesota | 55446 | — |
| 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 | — |
| NYU Langone Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Southtowns Gastroenterology, PLLC | Orchard Park | New York | 14127 | — |
| Penn State Hershey Medical Group | State College | Pennsylvania | 16803 | — |
| 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 | — |
| 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 97 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03566823, 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 May 11, 2021 · Synced Nov 4, 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 NCT03566823 live on ClinicalTrials.gov.