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

Last updated: September 26, 2023
Sponsor: Celltrion
Overall Status: Completed

Phase

3

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Placebo SC

CT-P13 SC (Infliximab)

Clinical Study ID

NCT03945019
CT-P13 3.8
2019-001087-30
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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 TNFαinhibitors for the treatment of CD.

Study Design

Total Participants: 396
Treatment Group(s): 2
Primary Treatment: Placebo SC
Phase: 3
Study Start date:
October 28, 2019
Estimated Completion Date:
August 22, 2023

Connect with a study center

  • Vitebsk Regional Clinical Hospital

    Vitebsk,
    Belarus

    Site Not Available

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia,
    Bulgaria

    Site Not Available

  • Clinical Hospital Centre Osijek

    Osijek,
    Croatia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava,
    Czechia

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite,
    France

    Site Not Available

  • Praxis Prof. Herbert Kellner

    München,
    Germany

    Site Not Available

  • University General Hospital of Heraklion

    Heraklion,
    Greece

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen,
    Hungary

    Site Not Available

  • Nirmal Hospital

    Surat,
    India

    Site Not Available

  • Sheba Medical Center

    Ramat-Gan,
    Israel

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Roma,
    Italy

    Site Not Available

  • Tsujinaka Hospital

    Kashiwa,
    Japan

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga,
    Latvia

    Site Not Available

  • BRCR Global Mexico

    Guadalajara,
    Mexico

    Site Not Available

  • IMSP Institute of Clinical Cardiology

    Chisinau,
    Moldova, Republic of

    Site Not Available

  • Hospital Nacional Cayetano Heredia

    San Martín de Porres,
    Peru

    Site Not Available

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

    Bydgoszcz,
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa,
    Poland

    Site Not Available

  • Dr.Carol Davila Emergency University Central Military Hospital

    Bucharest,
    Romania

    Site Not Available

  • Klinika YZI 4D

    Pyatigorsk,
    Russian Federation

    Site Not Available

  • BioTekhServis

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Clinical Hospital Centar Zvezdara

    Belgrade,
    Serbia

    Site Not Available

  • Fakultna nemocnica s poliklinikou F. D. Roosevelta

    Banska Bystrica,
    Slovakia

    Site Not Available

  • CLINRESCO, ARWYP Medical Suites

    Johannesburg,
    South Africa

    Site Not Available

  • Hospital Arquitecto Marcide

    Ferrol,
    Spain

    Site Not Available

  • Ege University Medical Faculty

    Izmir,
    Turkey

    Site Not Available

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

    Cherkassy,
    Ukraine

    Site Not Available

  • Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council

    Zaporizhzhia,
    Ukraine

    Site Not Available

  • GC GA DBA Consultants for Clinical Research

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Biopharma Informatic - Houston

    Houston, Texas 77084
    United States

    Site Not Available

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