Trial Outcomes & Findings for CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) (NCT NCT04205643)

NCT ID: NCT04205643

Last Updated: 2023-09-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

548 participants

Primary outcome timeframe

Week 54

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	CT-P13 IV 5mg/kg Induction phase: Patients who enrolled received induction doses of CT-P13 5mg/kg via intravenous (IV) infusion at Weeks 0, 2, and 6.	CT-P13 SC 120 mg Maintenance phase: Patients who were classified as clinical responder at Week 10 received CT-P13 120mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection \[2 shots\] of CT-P13 SC 120 mg) every 2 weeks.	Placebo Maintenance phase: Patients who were classified as clinical responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection \[2 shots\] of CT-P13 SC 120 mg) every 2 weeks.
Induction Phase STARTED	548	0	0
Induction Phase COMPLETED	438	0	0
Induction Phase NOT COMPLETED	110	0	0
Maintenance Phase STARTED	0	294	144
Maintenance Phase COMPLETED	0	240	113
Maintenance Phase NOT COMPLETED	0	54	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CT-P13 SC 120 mg n=294 Participants CT-P13 SC 120 mg	Placebo n=144 Participants Placebo	Total n=438 Participants Total of all reporting groups
Age, Continuous	38.2 years STANDARD_DEVIATION 12.78 • n=5 Participants	40.4 years STANDARD_DEVIATION 13.49 • n=7 Participants	38.9 years STANDARD_DEVIATION 13.04 • n=5 Participants
Sex: Female, Male Female	131 Participants n=5 Participants	61 Participants n=7 Participants	192 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants	83 Participants n=7 Participants	246 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	288 Participants n=5 Participants	140 Participants n=7 Participants	428 Participants n=5 Participants
Region of Enrollment Belarus	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Bulgaria	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Croatia	9 participants n=5 Participants	2 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Czechia	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Israel	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Italy	10 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Latvia	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Mexico	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Poland	135 participants n=5 Participants	65 participants n=7 Participants	200 participants n=5 Participants
Region of Enrollment Russia	56 participants n=5 Participants	21 participants n=7 Participants	77 participants n=5 Participants
Region of Enrollment Serbia	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment South Africa	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Turkey	7 participants n=5 Participants	2 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Ukraine	40 participants n=5 Participants	26 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 54

Population: All-randomized population

Outcome measures

Outcome measures
Measure	CT-P13 SC 120 mg n=294 Participants CT-P13 SC 120 mg	Placebo n=144 Participants Placebo
Percentage of Patients Achieving Clinical Remission at Week 54	127 Participants	30 Participants

SECONDARY outcome

Timeframe: Week 54

Population: All-randomized population

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.

Outcome measures

Outcome measures
Measure	CT-P13 SC 120 mg n=294 Participants CT-P13 SC 120 mg	Placebo n=144 Participants Placebo
Percentage Patients Achieving Clinical Response at Week 54	158 Participants	45 Participants

SECONDARY outcome

Timeframe: Week 54

Population: All-randomized population

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.

Outcome measures

Outcome measures
Measure	CT-P13 SC 120 mg n=294 Participants CT-P13 SC 120 mg	Placebo n=144 Participants Placebo
Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54	105 Participants	24 Participants

SECONDARY outcome

Timeframe: Week 54

Population: Patients who used oral corticosteroids at baseline among the All-randomized population

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.

Outcome measures

Outcome measures
Measure	CT-P13 SC 120 mg n=120 Participants CT-P13 SC 120 mg	Placebo n=61 Participants Placebo
Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54	44 Participants	11 Participants

Adverse Events

CT-P13 IV 5 mg/kg

Serious events: 23 serious events

Other events: 89 other events

Deaths: 0 deaths

CT-P13 SC 120 mg

Serious events: 15 serious events

Other events: 60 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CT-P13 IV 5 mg/kg n=548 participants at risk Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.	CT-P13 SC 120 mg n=296 participants at risk Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included.	Placebo n=140 participants at risk Patients who administered Placebo every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.
Blood and lymphatic system disorders Anaemia	6.2% 34/548 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	3.7% 11/296 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	3.6% 5/140 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Gastrointestinal disorders Colitis ulcerative	2.4% 13/548 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	4.4% 13/296 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	9.3% 13/140 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations COVID-19	2.4% 13/548 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	8.8% 26/296 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	6.4% 9/140 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Nasopharyngitis	1.6% 9/548 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	1.7% 5/296 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	5.0% 7/140 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Nervous system disorders Headache	5.5% 30/548 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	5.1% 15/296 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	5.0% 7/140 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.

Additional Information

Head of Clinical Planning

CELLTRION, Inc.

Phone: +82-32-850-4160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place