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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Biological: CT-P13 SC (Infliximab); Other: Placebo SC

• Registration Number: NCT04205643
• Lead Sponsor: Celltrion

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-19
• Study Start: 2020-09-01
• Primary Completion: 2022-07-07
• Results First Submitted: 2023-07-06
• Study Completion: 2023-07-11
• Status Verified: 2023-08
• Results First Submitted QC: 2023-09-26
• Last Update Submitted: 2023-09-26
• Results First Posted: 2023-09-28
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 548

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P13 SC	CT-P13 SC (Infliximab)	-
Placebo SC	Placebo SC	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving Clinical Remission at Week 54	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 Outcome Measures

Name	Time	Method
Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54	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.
Percentage Patients Achieving Clinical Response at Week 54	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.
Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54	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.

Trial Locations

Locations (1)

Centrum Zdrowia MDM; 🇵🇱 Warszawa, Poland