Phase 3
Completed N=548
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Source: ClinicalTrials.gov NCT04205643 ↗Enrolled (actual)
548
Serious AEs
4.3%
Results posted
Sep 2023
Primary outcomePrimary: Percentage of Patients Achieving Clinical Remission at Week 54 — 127; 30 Participants — p=<0.0001
◆ Published Evidence
Established
60citations · ~30 / year
Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY).
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
Linked Publications (4)
-
Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY).
-
Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY).
-
Impact of Immunogenicity on Clinical Outcomes in Patients With Moderate-to-Severe Inflammatory Bowel Disease Receiving Subcutaneous Infliximab: A Post Hoc Analysis of the LIBERTY Trials.
-
Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.