NCT04205643

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

December 18, 2019

Results QC Date

July 6, 2023

Last Update Submit

September 26, 2023

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Percentage Patients Achieving Clinical Response at Week 54

    Week 54

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

    Week 54

  • Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54

    Week 54

Study Arms (2)

CT-P13 SC

EXPERIMENTAL
Biological: CT-P13 SC (Infliximab)

Placebo SC

PLACEBO COMPARATOR
Other: Placebo SC

Interventions

CT-P13 SC (Infliximab)BIOLOGICAL

Subcutaneous injection of CT-P13 SC

CT-P13 SC
Placebo SCOTHER

Subcutaneous injection of Placebo SC

Placebo SC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum Zdrowia MDM

Warsaw, 00-728, Poland

Location

Related Publications (2)

  • Colombel JF, Sandborn WJ, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Kim JM, Park G, Lee J, Lee J, Ryu JY, Sands BE, Hanauer SB. Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY). J Crohns Colitis. 2025 Jun 4;19(6):jjaf060. doi: 10.1093/ecco-jcc/jjaf060.

    PMID: 40243842DERIVED

  • Hanauer SB, Sands BE, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Yang S, Lee J, Lee J, Kim JM, Park G, Sandborn WJ, Colombel JF. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY). Gastroenterology. 2024 Oct;167(5):919-933. doi: 10.1053/j.gastro.2024.05.006. Epub 2024 May 23.

    PMID: 38788861DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Head of Clinical Planning
Organization
CELLTRION, Inc.
YunJu.Bae@celltrion.com
+82-32-850-4160

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 19, 2019

Study Start

September 1, 2020

Primary Completion

July 7, 2022

Study Completion

July 11, 2023

Last Updated

September 28, 2023

Results First Posted

September 28, 2023

Record last verified: 2023-08

Locations

PL(1)