Ulcerative ColitisPhase 3NCT04205643
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
A Phase 3 study testing CT-P13 SC (Infliximab) in people with Ulcerative Colitis, run by Celltrion at 1 site in Poland.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- CT-P13 SC (Infliximab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 548 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2020to 11 Jul 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Ulcerative Colitis
- Being tested
- CT-P13 SC (Infliximab), Placebo SC
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P13 SC (Infliximab)Biological
Subcutaneous injection of CT-P13 SC
Placebo SCOther
Subcutaneous injection of Placebo SC
| Study group | Role | What they receive |
|---|---|---|
| CT-P13 SC | Experimental | Not described Receives: Biological: CT-P13 SC (Infliximab) |
| Placebo SC | Placebo comparator | Not described Receives: Other: Placebo SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 54
Secondary outcomes (3)
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.
Measured: Week 54
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.
Measured: Week 54
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.
Measured: Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Sep 2020
- Primary completion7 Jul 2022
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205643
- Sponsor's protocol ID
- CT-P13 3.7
- Other IDs
- 2019-003849-15, 2019
- Status last verified
- Aug 2023
- First submitted
- 18 Dec 2019
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Colombel JF, Danese S, Schreiber S, Sands BE, Yarur AJ, Kang A, Kim DH, Lee YN, Hanauer SB. Impact of Immunogenicity on Clinical Outcomes in Patients With Moderate-to-Severe Inflammatory Bowel Disease Receiving Subcutaneous Infliximab: A Post Hoc Analysis of the LIBERTY Trials. United European Gastroenterol J. 2026 Apr;14(3):e70205. doi: 10.1002/ueg2.70205.
PubMed 41986154Dubinsky MC, Schreiber S, Yarur AJ, Sands BE, Hanauer SB, Danese S, Yu H, Kim DH, Lee YN, Colombel JF. Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials. Inflamm Bowel Dis. 2026 Jul 1;32(7):1235-1247. doi: 10.1093/ibd/izag017.
PubMed 41849243Colombel 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.
PubMed 40243842Hanauer 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.
PubMed 38788861
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04205643
- Acronym / sponsor ID
- CT-P13 3.7
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-P13 SC | Experimental | Biological: CT-P13 SC (Infliximab) |
| Placebo SC | Placebo comparator | Other: Placebo SC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P13 SC (Infliximab)Subcutaneous injection of CT-P13 SC | Biological | CT-P13 SC |
| Placebo SCSubcutaneous injection of Placebo SC | Other | Placebo SC |
Primary outcome
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.
3 secondary outcomes
Percentage Patients Achieving Clinical Response at Week 54
Time frame: Week 54
Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54
Time frame: Week 54
Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54
Time frame: Week 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41986154Colombel JF, Danese S, Schreiber S, Sands BE, Yarur AJ, Kang A, Kim DH, Lee YN, Hanauer SB. Impact of Immunogenicity on Clinical Outcomes in Patients With Moderate-to-Severe Inflammatory Bowel Disease Receiving Subcutaneous Infliximab: A Post Hoc Analysis of the LIBERTY Trials. United European Gastroenterol J. 2026 Apr;14(3):e70205. doi: 10.1002/ueg2.70205.
- Derived from this study: PubMed 41849243Dubinsky MC, Schreiber S, Yarur AJ, Sands BE, Hanauer SB, Danese S, Yu H, Kim DH, Lee YN, Colombel JF. Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials. Inflamm Bowel Dis. 2026 Jul 1;32(7):1235-1247. doi: 10.1093/ibd/izag017.
- Derived from this study: PubMed 40243842Colombel 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.
- Derived from this study: PubMed 38788861Hanauer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT-P13 SC (Infliximab) in people with Ulcerative Colitis, run by Celltrion at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Achieving Clinical Remission at Week 54 (time frame: Week 54). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04205643, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.