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Completed

NCT Number: NCT04205643

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

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 Ulcerative Colitis

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centrum Zdrowia MDM

Warsaw, 00-728, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 TNFα inhibitor or biologic agent within 5 half-lives

Treatment and study plan

CT-P13 SC (Infliximab)

Biological

Subcutaneous injection of CT-P13 SC

Placebo SC

Other

Subcutaneous injection of Placebo SC

Primary outcomes

  1. Percentage of Patients Achieving Clinical Remission at Week 54

    Time frame: Week 54

    Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score.

    Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Secondary outcomes

  1. Percentage Patients Achieving Clinical Response at Week 54

    Time frame: Week 54

    Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.

  2. Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54

    Time frame: Week 54

    Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved.

  3. Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54

    Time frame: Week 54

    Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 19, 2019
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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