Trials / Completed
CompletedNCT04205643
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
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 Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 548 (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 Ulcerative Colitis
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
- 2020-09-01
- Primary completion
- 2022-07-07
- Completion
- 2023-07-11
- First posted
- 2019-12-19
- Last updated
- 2023-09-28
- Results posted
- 2023-09-28
Locations
1 site across 1 country: Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04205643. Inclusion in this directory is not an endorsement.