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

NCT ID: NCT03945019

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2023-08-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CT-P13 SC

Group Type: EXPERIMENTAL

CT-P13 SC (Infliximab)

Intervention Type: BIOLOGICAL

Subcutaneous injection of CT-P13 SC

Placebo SC

Group Type: PLACEBO_COMPARATOR

Placebo SC

Intervention Type: OTHER

Subcutaneous injection of Placebo SC

Interventions

CT-P13 SC (Infliximab)

Subcutaneous injection of CT-P13 SC

Intervention Type: BIOLOGICAL

Placebo SC

Subcutaneous injection of Placebo SC

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biopharma Informatic - Houston

Houston, Texas, United States

Vitebsk Regional Clinical Hospital

Vitebsk, , Belarus

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, , Bulgaria

Clinical Hospital Centre Osijek

Osijek, , Croatia

Fakultni nemocnice Ostrava

Ostrava, , Czechia

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Praxis Prof. Herbert Kellner

München, , Germany

University General Hospital of Heraklion

Heraklion, , Greece

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Nirmal Hospital

Surat, , India

Sheba Medical Center

Ramat Gan, , Israel

Fondazione Policlinico Universitario A Gemelli-Rome

Roma, , Italy

Tsujinaka Hospital

Kashiwa, , Japan

Pauls Stradins Clinical University Hospital

Riga, , Latvia

BRCR Global Mexico

Guadalajara, , Mexico

IMSP Institute of Clinical Cardiology

Chisinau, , Moldova

Hospital Nacional Cayetano Heredia

San Martín de Porres, , Peru

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

Bydgoszcz, , Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Dr.Carol Davila Emergency University Central Military Hospital

Bucharest, , Romania

Klinika YZI 4D

Pyatigorsk, , Russia

BioTekhServis

Saint Petersburg, , Russia

Clinical Hospital Centar Zvezdara

Belgrade, , Serbia

Fakultna nemocnica s poliklinikou F. D. Roosevelta

Banská Bystrica, , Slovakia

CLINRESCO, ARWYP Medical Suites

Johannesburg, , South Africa

Hospital Arquitecto Marcide

Ferrol, , Spain

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

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

Cherkassy, , Ukraine

Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council

Zaporizhzhia, , Ukraine

Countries

United States; Belarus; Bulgaria; Croatia; Czechia; France; Germany; Greece; Hungary; India; Israel; Italy; Japan; Latvia; Mexico; Moldova; Peru; Poland; Romania; Russia; Serbia; Slovakia; South Africa; Spain; Turkey (Türkiye); Ukraine

References

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.

Reference Type: DERIVED

PMID: 40243842 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38788861 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-001087-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-P13 3.8

Identifier Type: -

Identifier Source: org_study_id