TriangleNCT03945019 · CITED IN SOURCE DOCUMENTS
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2023-10-23
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 Crohn's Disease
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
Percentage of Patients Achieving CDAI-100 Response at Week 54
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Patient is male or female aged 18 to 75 years, inclusive. * Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points Exclusion Criteria: * Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives * Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.
- healthy Volunteers
- false
- maximum Age
- 75 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Biological: CT-P13 SC (Infliximab)
- label
- CT-P13 SC
- type
- EXPERIMENTAL
- intervention Names
- Other: Placebo SC
- label
- Placebo SC
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- CT-P13 SC
- description
- Subcutaneous injection of CT-P13 SC
- name
- CT-P13 SC (Infliximab)
- type
- BIOLOGICAL
- arm Group Labels
- Placebo SC
- description
- Subcutaneous injection of Placebo SC
- name
- Placebo SC
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 396
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of \<150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
- measure
- Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
- time Frame
- Week 54
- description
- Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.
- measure
- Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
- time Frame
- Week 54
- secondary Outcomes
- description
- Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
- measure
- Percentage of Patients Achieving CDAI-100 Response at Week 54
- time Frame
- Week 54
- description
- Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value. AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
- measure
- Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
- time Frame
- Week 54
- description
- Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of \>1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
- measure
- Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54
- time Frame
- Week 54
Full study description
- 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 Crohn's Disease
Source references
- references
- citation
- 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.
- pmid
- 41986154
- type
- DERIVED
- citation
- Schreiber S, Sands BE, Danese S, Loftus EV Jr, Jeong AL, Kim DH, Lee YN, Colombel JF. Symptom Response Dynamics for Personalised Therapy with Subcutaneous Infliximab in Crohn's Disease: Insights from the Randomised, Placebo-Controlled, Phase 3 LIBERTY-CD Trial. Adv Ther. 2026 Jun;43(6):2510-2526. doi: 10.1007/s12325-026-03533-3. Epub 2026 Mar 30.
- pmid
- 41910935
- type
- DERIVED
- citation
- Dubinsky 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.
- pmid
- 41849243
- type
- DERIVED
- citation
- 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
- 40243842
- type
- DERIVED
- citation
- 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
- 38788861
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- . 14.2 Adult Crohn's Disease The safety and efficacy of ZYMFENTRA were assessed in a randomized, double-blind, placebo-controlled clinical studies (CD Trial I; NCT03945019) in adult subjects with moderately to severely active CD, defined as Crohn's Disease Activity Index (CDAI) score of 220 to 450 points, and a centrally-reveiwed
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Preserved source evidence · Not medical advice