Trials / Terminated
TerminatedNCT03559517
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)
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)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (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
- 2018-08-29
- Primary completion
- 2020-07-07
- Completion
- 2020-10-08
- First posted
- 2018-06-18
- Last updated
- 2021-04-29
- Results posted
- 2021-04-29
Locations
138 sites across 16 countries: United States, Australia, Austria, Croatia, Germany, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Russia, Serbia, South Africa, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03559517. Inclusion in this directory is not an endorsement.