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

Study Overview
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Brief Summary
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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

Official Title
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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 Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Biological: CT-P13 SC (Infliximab)
* Other: Placebo SC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P13 SC<br> | Biological: CT-P13 SC (Infliximab)<br>* Subcutaneous injection of CT-P13 SC<br>|
| Placebo Comparator: Placebo SC<br> | Other: Placebo SC<br>* Subcutaneous injection of Placebo SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of <150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Week 54 | 
| Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level. | Week 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Achieving CDAI-100 Response at Week 54 | Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. | Week 54 | 
| Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value. AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Week 54 | 
| Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of >1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. | Week 54 |