CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Jan 13, 2023
  • participants needed
    615
  • sponsor
    Celltrion
Updated on 13 May 2021
infliximab

Summary

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Placebo SC, CT-P13 SC (Infliximab)
Clinical Study IdentifierNCT04205643
SponsorCelltrion
Last Modified on13 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient is male or female aged 18 to 75 years, inclusive
Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of 2 points

Exclusion Criteria

Patient who has previously received 2 or more biologic agents and/or JAK inhibitors
Patient who has previously received either a TNF inhibitor or biologic agent within 5 half-lives
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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