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

Ulcerative Colitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205643
• Other study ID #: CT-P13 3.7
• Secondary ID: 2019-003849-15
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: July 11, 2023

Study information

• Verified date: August 2023
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Ulcerative Colitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: July 11, 2023
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 TNFa inhibitor or biologic agent within 5 half-lives

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• CT-P13 SC (Infliximab)
Subcutaneous injection of CT-P13 SC

Other:
• Placebo SC
Subcutaneous injection of Placebo SC

Locations

Country	Name	City	State
Poland	Centrum Zdrowia MDM	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Achieving Clinical Remission at 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.	Week 54
Secondary	Percentage Patients Achieving Clinical Response at 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.	Week 54
Secondary	Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at 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.	Week 54
Secondary	Percentage of Patients Achieving Corticosteroid-Free Remission at 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.	Week 54