Phase 3 N=396 Randomized Quadruple-blind Treatment

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)

Crohn's Disease

Bottom Line

View on ClinicalTrials.gov: NCT03945019 ↗

Enrolled (actual)

396

Serious AEs

5.1%

Results posted

Oct 2023

Primary outcome: Primary: Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 — 144; 36 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: Aug 2022

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	—

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03945019). 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.