Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)
Public ClinicalTrials.gov record NCT03559517. 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 Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)
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
- NCT03559517
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 30 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
- Aug 28, 2018
- Primary completion
- Jul 6, 2020
- Completion
- Oct 7, 2020
- Last update posted
- Apr 28, 2021
2018 – 2020
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CATS Research Center - University of Arizona | Tucson | Arizona | 85724 | — |
| Atria Clinical Research - Clinedge - PPDS | Little Rock | Arkansas | 72209 | — |
| OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster | California | 93534 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80903 | — |
| Asthma and Allergy Associates PC - CRN - PPDS | Colorado Springs | Colorado | 80907 | — |
| Advanced Clinical Research Network | Miami | Florida | 33176 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Omega Research Consultants LLC - Clinedge - PPDS | Orlando | Florida | 32810 | — |
| East Coast Institute for Research, LLC | Saint Augustine | Florida | 32086 | — |
| Laporte County Institute For Clinical Research | Michigan City | Indiana | 46360 | — |
| Clinical Trials of SWLA LLC | Lake Charles | Louisiana | 70601 | — |
| Louisiana Research Center LLC | Shreveport | Louisiana | 71103 | — |
| New York Total Medical Care PC | Brooklyn | New York | 11215 | — |
| 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 | — |
| 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 | — |
| Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS | Baytown | Texas | 77521 | — |
| Northside Gastroenterology | Cypress | Texas | 77429 | — |
| HP Clinical Research | Bountiful | Utah | 84010 | — |
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 113 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03559517, 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 28, 2021 · Synced Sep 3, 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 protocol, eligibility criteria, and contact information for NCT03559517 live on ClinicalTrials.gov.