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

NCT03945019 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CT-P13 3.82019-001087-30
• Study Type: interventional
• Target: 396
• Locations: 26 countries
• Sites: 29

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Percentage of Patients Achieving CDAI-100 Response at Week 54

  Week 54

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

  Week 54

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

  Week 54

Study Arms (2)

CT-P13 SC

EXPERIMENTAL

Biological: CT-P13 SC (Infliximab)

Placebo SC

PLACEBO COMPARATOR

Other: Placebo SC

Interventions

CT-P13 SC (Infliximab) BIOLOGICAL

Subcutaneous injection of CT-P13 SC

CT-P13 SC

Placebo SC OTHER

Subcutaneous injection of Placebo SC

Placebo SC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (29)

Biopharma Informatic - Houston

Houston, Texas, 77084, United States

Location

Vitebsk Regional Clinical Hospital

Vitebsk, Belarus

Location

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Bulgaria

Location

Clinical Hospital Centre Osijek

Osijek, Croatia

Location

Fakultni nemocnice Ostrava

Ostrava, Czechia

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Praxis Prof. Herbert Kellner

München, Germany

Location

University General Hospital of Heraklion

Heraklion, Greece

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Location

Nirmal Hospital

Surat, India

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Fondazione Policlinico Universitario A Gemelli-Rome

Roma, Italy

Location

Tsujinaka Hospital

Kashiwa, Japan

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

BRCR Global Mexico

Guadalajara, Mexico

Location

IMSP Institute of Clinical Cardiology

Chisinau, Moldova

Location

Hospital Nacional Cayetano Heredia

San Martín de Porres, Peru

Location

Szpital Uniwersytecki Nr 2 im. dr Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia

Bydgoszcz, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Location

Dr.Carol Davila Emergency University Central Military Hospital

Bucharest, Romania

Location

Klinika YZI 4D

Pyatigorsk, Russia

Location

BioTekhServis

Saint Petersburg, Russia

Location

Clinical Hospital Centar Zvezdara

Belgrade, Serbia

Location

Fakultna nemocnica s poliklinikou F. D. Roosevelta

Banská Bystrica, Slovakia

Location

CLINRESCO, ARWYP Medical Suites

Johannesburg, South Africa

Location

Hospital Arquitecto Marcide

Ferrol, Spain

Location

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

Location

Communal Non-Commercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkassy, Ukraine

Location

Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council

Zaporizhzhia, Ukraine

Location

Related Publications (2)

• Colombel JF, Sandborn WJ, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Kim JM, Park G, Lee J, Lee J, Ryu JY, Sands BE, Hanauer SB. Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY). J Crohns Colitis. 2025 Jun 4;19(6):jjaf060. doi: 10.1093/ecco-jcc/jjaf060.

  PMID: 40243842 DERIVED

• Hanauer SB, Sands BE, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Yang S, Lee J, Lee J, Kim JM, Park G, Sandborn WJ, Colombel JF. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY). Gastroenterology. 2024 Oct;167(5):919-933. doi: 10.1053/j.gastro.2024.05.006. Epub 2024 May 23.

  PMID: 38788861 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Head of Clinical Planning
• Organization: CELLTRION, Inc.

YunJu.Bae@celltrion.com

+82-32-850-4160

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: October 28, 2019
• Primary Completion: August 23, 2022
• Study Completion: August 22, 2023
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-09

Locations

ME (1); HU (1); US (1); IN (1); GR (1); IL (1); IT (1); PL (2); RU (2); RO (1); SE (1); UA (2); MO (1); ES (1); TU (1); CR (1); ZA (1); PE (1); CZ (1); FR (1); SL (1); BE (1); LA (1); BU (1); DE (1); JP (1)