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

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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

Key facts

Study ID

NCT03945019

Run by

Celltrion

People needed

396

Starts

2019-10-28

Expected to finish

2023-08-22

Last updated by the study team

2023-10-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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