Phase 3
Completed N=396
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
Source: ClinicalTrials.gov NCT03945019 ↗Enrolled (actual)
396
Serious AEs
5.1%
Results posted
Oct 2023
Primary outcomePrimary: Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 — 144; 36 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 Crohn's Disease
Linked Publications (5)
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Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY).
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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).
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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.
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Symptom Response Dynamics for Personalised Therapy with Subcutaneous Infliximab in Crohn's Disease: Insights from the Randomised, Placebo-Controlled, Phase 3 LIBERTY-CD Trial.
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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 (Based on CDAI) at Week 54 |
144; 36 | <0.0001 sig |
| PRIMARY Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 |
118; 20 | <0.0001 sig |
| SECONDARY Percentage of Patients Achieving CDAI-100 Response at Week 54 |
152; 43 | — |
| SECONDARY Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 |
131; 35 | — |
| SECONDARY Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 |
80; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is male or female aged 18 to 75 years, inclusive.
- Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points
Exclusion Criteria
- Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
- Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.
Data sourced from ClinicalTrials.gov (NCT03945019) 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.