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

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

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

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: CT-P13 SC (Infliximab); Other: Placebo SC

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Vitebsk, Belarus
    • Vitebsk Regional Clinical Hospital
• Bulgaria
  • Sofia, Bulgaria
    • Diagnostic and Consulting Center Aleksandrovska EOOD
• Croatia
  • Osijek, Croatia
    • Clinical Hospital Centre Osijek
• Czechia
  • Ostrava, Czechia
    • Fakultni Nemocnice Ostrava
• France
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud
• Germany
  • München, Germany
    • Praxis Prof. Herbert Kellner
• Greece
  • Heraklion, Greece
    • University General Hospital of Heraklion
• Hungary
  • Debrecen, Hungary
    • Debreceni Egyetem Klinikai Kozpont
• India
  • Surat, India
    • Nirmal Hospital
• Israel
  • Ramat-Gan, Israel
    • Sheba Medical Center
• Italy
  • Roma, Italy
    • Fondazione Policlinico Universitario A Gemelli-Rome
• Japan
  • Kashiwa, Japan
    • Tsujinaka Hospital
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
• Mexico
  • Guadalajara, Mexico
    • BRCR Global Mexico
• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • IMSP Institute of Clinical Cardiology
• Peru
  • San Martín de Porres, Peru
    • Hospital Nacional Cayetano Heredia
• Poland
  • Bydgoszcz, Poland
    • Szpital Uniwersytecki Nr 2 im. dr Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia
  • Warszawa, Poland
    • WIP Warsaw IBD Point Profesor Kierkus
• Romania
  • Bucharest, Romania
    • Dr.Carol Davila Emergency University Central Military Hospital
• Russian Federation
  • Pyatigorsk, Russian Federation
    • Klinika YZI 4D
  • St. Petersburg, Russian Federation
    • BioTekhServis
• Serbia
  • Belgrade, Serbia
    • Clinical Hospital Centar Zvezdara
• Slovakia
  • Banska Bystrica, Slovakia
    • Fakultna nemocnica s poliklinikou F. D. Roosevelta
• South Africa
  • Johannesburg, South Africa
    • CLINRESCO, ARWYP Medical Suites
• Spain
  • Ferrol, Spain
    • Hospital Arquitecto Marcide
• Turkey
  • Izmir, Turkey
    • Ege University Medical Faculty
• Ukraine
  • Cherkassy, Ukraine
    • Communal Non-Commercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
  • Zaporizhzhia, Ukraine
    • Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
• United States
  • Texas
    • Houston, Texas, United States, 77084
      • Biopharma Informatic - Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo SC	Other: Placebo SC; Subcutaneous injection of Placebo SC
Experimental: CT-P13 SC	Biological: CT-P13 SC (Infliximab); Subcutaneous injection of CT-P13 SC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celltrion

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): August 23, 2022
• Study Completion (Actual): August 22, 2023

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Tumor Necrosis Factor Inhibitors; Infliximab
• Other Study ID Numbers: CT-P13 3.8; 2019-001087-30 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No