Trials / Completed
CompletedNCT03945019
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 396 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT-P13 SC (Infliximab) | Subcutaneous injection of CT-P13 SC |
| OTHER | Placebo SC | Subcutaneous injection of Placebo SC |
Timeline
- Start date
- 2019-10-28
- Primary completion
- 2022-08-23
- Completion
- 2023-08-22
- First posted
- 2019-05-10
- Last updated
- 2023-10-23
- Results posted
- 2023-10-23
Locations
29 sites across 26 countries: United States, Belarus, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Mexico, Moldova, Peru, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03945019. Inclusion in this directory is not an endorsement.