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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945019
• Other study ID #: CT-P13 3.8
• Secondary ID: 2019-001087-30
• Status: Completed
• Phase: Phase 3
• Start date: October 28, 2019
• Est. completion date: August 22, 2023

Study information

• Verified date: September 2023
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: August 22, 2023
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 TNFa inhibitor or biological agent within 5 half-lives

• Patient who has previously demonstrated inadequate response or intolerance to TNFa inhibitors for the treatment of CD.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• CT-P13 SC (Infliximab)
Subcutaneous injection of CT-P13 SC

Other:
• Placebo SC
Subcutaneous injection of Placebo SC

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Countries where clinical trial is conducted

United States,  Belarus,  Bulgaria,  Croatia,  Czechia,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Latvia,  Mexico,  Moldova, Republic of,  Peru,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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