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Completed

NCT Number: NCT03945019

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

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

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vitebsk Regional Clinical Hospital, Vitebsk, Belarus

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT-P13 SC (Infliximab)

Biological

Subcutaneous injection of CT-P13 SC

Placebo SC

Other

Subcutaneous injection of Placebo SC

Primary outcomes

  1. Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54

    Time frame: 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.

  2. Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54

    Time frame: 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.

Secondary outcomes

  1. Percentage of Patients Achieving CDAI-100 Response at Week 54

    Time frame: 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.

  2. Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54

    Time frame: 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.

  3. Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
May 10, 2019
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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