Back to resultsCT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CT-P13 SC (Infliximab)
Placebo SC
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Biopharma Informatic - Houston
- Vitebsk Regional Clinical Hospital
- Diagnostic and Consulting Center Aleksandrovska EOOD
- Clinical Hospital Centre Osijek
- Fakultni nemocnice Ostrava
- Centre Hospitalier Lyon Sud
- Praxis Prof. Herbert Kellner
- University General Hospital of Heraklion
- Debreceni Egyetem Klinikai Kozpont
- Nirmal Hospital
- Sheba Medical Center
- Fondazione Policlinico Universitario A Gemelli-Rome
- Tsujinaka Hospital
- Pauls Stradins Clinical University Hospital
- BRCR Global Mexico
- IMSP Institute of Clinical Cardiology
- Hospital Nacional Cayetano Heredia
- Szpital Uniwersytecki Nr 2 im. dr Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia
- WIP Warsaw IBD Point Profesor Kierkus
- Dr.Carol Davila Emergency University Central Military Hospital
- Klinika YZI 4D
- BioTekhServis
- Clinical Hospital Centar Zvezdara
- Fakultna nemocnica s poliklinikou F. D. Roosevelta
- CLINRESCO, ARWYP Medical Suites
- Hospital Arquitecto Marcide
- Ege University Medical Faculty
- Communal Non-Commercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
- Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CT-P13 SC
Placebo SC
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03945019
Brief Title
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
August 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P13 SC
Arm Type
Experimental
Arm Title
Placebo SC
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CT-P13 SC (Infliximab)
Intervention Description
Subcutaneous injection of CT-P13 SC
Intervention Type
Other
Intervention Name(s)
Placebo SC
Intervention Description
Subcutaneous injection of Placebo SC
Primary Outcome Measure Information:
Title
Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
Description
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.
Time Frame
Week 54
Title
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
Description
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.
Time Frame
Week 54
Secondary Outcome Measure Information:
Title
Percentage of Patients Achieving CDAI-100 Response at Week 54
Description
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.
Time Frame
Week 54
Title
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
Description
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.
Time Frame
Week 54
Title
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54
Description
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.
Time Frame
Week 54
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Biopharma Informatic - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
Country
Belarus
Facility Name
Diagnostic and Consulting Center Aleksandrovska EOOD
City
Sofia
Country
Bulgaria
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
Country
Croatia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
Country
Czechia
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Facility Name
Praxis Prof. Herbert Kellner
City
München
Country
Germany
Facility Name
University General Hospital of Heraklion
City
Heraklion
Country
Greece
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
Country
Hungary
Facility Name
Nirmal Hospital
City
Surat
Country
India
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Facility Name
Fondazione Policlinico Universitario A Gemelli-Rome
City
Roma
Country
Italy
Facility Name
Tsujinaka Hospital
City
Kashiwa
Country
Japan
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
BRCR Global Mexico
City
Guadalajara
Country
Mexico
Facility Name
IMSP Institute of Clinical Cardiology
City
Chisinau
Country
Moldova, Republic of
Facility Name
Hospital Nacional Cayetano Heredia
City
San Martín de Porres
Country
Peru
Facility Name
Szpital Uniwersytecki Nr 2 im. dr Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia
City
Bydgoszcz
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
Country
Poland
Facility Name
Dr.Carol Davila Emergency University Central Military Hospital
City
Bucharest
Country
Romania
Facility Name
Klinika YZI 4D
City
Pyatigorsk
Country
Russian Federation
Facility Name
BioTekhServis
City
St. Petersburg
Country
Russian Federation
Facility Name
Clinical Hospital Centar Zvezdara
City
Belgrade
Country
Serbia
Facility Name
Fakultna nemocnica s poliklinikou F. D. Roosevelta
City
Banska Bystrica
Country
Slovakia
Facility Name
CLINRESCO, ARWYP Medical Suites
City
Johannesburg
Country
South Africa
Facility Name
Hospital Arquitecto Marcide
City
Ferrol
Country
Spain
Facility Name
Ege University Medical Faculty
City
Izmir
Country
Turkey
Facility Name
Communal Non-Commercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
City
Cherkassy
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
City
Zaporizhzhia
Country
Ukraine
12. IPD Sharing Statement
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CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
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