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

  • STATUS
    Recruiting
  • End date
    Jan 10, 2023
  • participants needed
    615
  • sponsor
    Celltrion
Updated on 10 September 2020
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
Treatment Placebo SC, CT-P13 SC (Infliximab)
Clinical Study IdentifierNCT04205643
SponsorCelltrion
Last Modified on10 September 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Ulcerative Colitis or Ulcerative Colitis (Pediatric)?
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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Step 3 Enroll in the clinical study

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