Phase 3
N=548
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT04205643 ↗Enrolled (actual)
548
Serious AEs
4.3%
Results posted
Sep 2023
Primary outcome: Primary: Percentage of Patients Achieving Clinical Remission at Week 54 — 127; 30 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CT-P13 SC (Infliximab) (Biological); Placebo SC (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celltrion
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving Clinical Remission at Week 54 |
127; 30 | <0.0001 sig |
| SECONDARY Percentage Patients Achieving Clinical Response at Week 54 |
158; 45 | — |
| SECONDARY Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54 |
105; 24 | — |
| SECONDARY Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54 |
44; 11 | — |
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
Eligibility Criteria
Inclusion Criteria
- Patient is male or female aged 18 to 75 years, inclusive.
- Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points
Exclusion Criteria
- Patient who has previously received 2 or more biologic agents and/or JAK inhibitors
- Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives
Data sourced from ClinicalTrials.gov (NCT04205643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.