Trials / Terminated
TerminatedNCT03566823
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
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)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 34 (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 in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
Detailed description
27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ontamalimab | Subcutaneous injection of ontamalimab will be administered using a prefilled syringe. |
| OTHER | Placebo | Subcutaneous injection of placebo matched with ontamalimab will be administered using a prefilled syringe. |
Timeline
- Start date
- 2018-07-17
- Primary completion
- 2020-08-18
- Completion
- 2020-08-18
- First posted
- 2018-06-25
- Last updated
- 2021-05-11
- Results posted
- 2021-05-11
Locations
145 sites across 20 countries: United States, Argentina, Belgium, Bosnia and Herzegovina, Bulgaria, Colombia, Estonia, Greece, Hungary, Ireland, Japan, Lebanon, Mexico, New Zealand, Portugal, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03566823. Inclusion in this directory is not an endorsement.