Trials / Terminated
TerminatedNCT03627091
Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
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)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 16 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ontamalimab | SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe. |
| OTHER | Placebo | SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe. |
Timeline
- Start date
- 2019-02-06
- Primary completion
- 2021-06-21
- Completion
- 2021-09-13
- First posted
- 2018-08-13
- Last updated
- 2022-03-31
- Results posted
- 2022-03-31
Locations
281 sites across 34 countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Colombia, Croatia, Estonia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03627091. Inclusion in this directory is not an endorsement.