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

NCT03945019 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2023-10-23

Study results available
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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

Interventions

BIOLOGICAL

CT-P13 SC (Infliximab)

Subcutaneous injection of CT-P13 SC

OTHER

Placebo SC

Subcutaneous injection of Placebo SC

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2022-08-23
Completion
2023-08-22
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945019 on ClinicalTrials.gov