Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study

Start Date01 Sep 2025

Sponsor / Collaborator

UZ Leuven

JPRN-jRCT2031250197

/ SuspendedPhase 3

Single-arm, Open-label, Phase 3, Multi-center Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Ulcerative Colitis in Japan (CT-P13 3.13)

Start Date14 Jun 2025

Sponsor / Collaborator

Celltrion Healthcare Japan KK

CTIS2024-513213-13-00

/ RecruitingPhase 4IIT

Direct comparison between NSAIDs and biosimilar TNFa blockers in patients with axial spondyloarthritis

Start Date13 Mar 2025

Sponsor / Collaborator-

100 Clinical Results associated with Infliximab-dyyb (Celltrion)

100 Translational Medicine associated with Infliximab-dyyb (Celltrion)

100 Patents (Medical) associated with Infliximab-dyyb (Celltrion)

439

Literatures (Medical) associated with Infliximab-dyyb (Celltrion)

01 Jun 2026·ADVANCES IN THERAPY

Symptom Response Dynamics for Personalised Therapy with Subcutaneous Infliximab in Crohn’s Disease: Insights from the Randomised, Placebo-Controlled, Phase 3 LIBERTY-CD Trial

Article

Author: Kim, Dong-Hyeon ; Jeong, Ae Lee ; Colombel, Jean-Frédéric ; Loftus, Edward V ; Sands, Bruce E ; Danese, Silvio ; Lee, Young Nam ; Schreiber, Stefan

INTRODUCTION:

The LIBERTY-CD study demonstrated superior efficacy of subcutaneous infliximab-dyyb over placebo for maintenance therapy in patients with Crohn's disease. This post hoc analysis characterised subgroups of patients with different response levels to subcutaneous infliximab.

METHODS:

Group-based trajectory modelling was conducted to deconvolute cohort-level data into individual response trajectories based on longitudinal patient-reported outcomes. Potential predictors of subcutaneous infliximab response were explored using multivariable analyses. Subgroups were compared for clinical, endoscopic, biochemical, and health-related quality of life outcomes; comprehensive disease control (achieving composite endpoints) at week 54; pre-dose serum infliximab levels; and safety.

RESULTS:

Four distinct subgroups of patients were identified: super-responders (rapid and high sustained improvement); fast responders; slow responders; and limited responders (partial improvement). In multivariable analyses, lower baseline body mass index (p = 0.022) and pre-dose serum infliximab levels ≥ 14 μg/ml at week 10 (p = 0.003) were associated with a super-response. At week 54, super-responders showed the highest rates of clinical remission (80.3%; p = 0.002), endoscopic response (63.9%; p = 0.009), health-related quality of life remission (72.1%; p = 0.0002), corticosteroid-free remission (59.1%; p = 0.007), and comprehensive disease control achievement (27.9%; p = 0.014) versus other trajectories. Among groups, super-responders maintained the highest pre-dose serum infliximab levels from week 10. Comparable overall safety profiles were observed across groups.

CONCLUSION:

Distinct subpopulations with varying responses to infliximab were identified by group-based trajectory modelling using longitudinal symptom data, which may support the development of personalised therapy. Super-responders with rapid and sustained improvements during infliximab therapy were more likely to achieve desirable long-term outcomes.

TRIAL REGISTRATION:

ClinicalTrials. gov identifier, NCT03945019 (08 May 2019).

01 Jun 2026·International Journal of Rheumatic Diseases

Association of Body Mass Index with SARS ‐ CoV ‐2 Infection in Inflammatory Arthritis Patients Receiving Biologic Therapy: Singapore National Biologics Register Findings

Article

Author: Angkodjojo, Stanley ; Lim, Rosa ; Ma, Margaret ; Yeo, Siaw Ing ; Wong, Stephanie ; Lahiri, Manjari ; Koh, Li Wearn ; Khor, Andrew Yu Keat ; Ng, Yi Xin ; Dhanasekaran, Preeti

ABSTRACT:

Purpose:

To determine the association of body mass index (BMI) with incident COVID‐19 infection in patients with inflammatory arthritis (IA) using biologic disease‐modifying anti‐rheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs) and to describe characteristics of patients with severe COVID‐19 infection.

Methods:

This prospective inception cohort study included IA patients ≥ 21 years old initiating a bDMARD after July 2016 across five public hospitals in Singapore. Data were collected via questionnaires and electronic medical records. Baseline characteristics were compared between patients who developed COVID‐19 and those who did not. The association between BMI and time to incident COVID‐19 infection was assessed using Cox proportional hazards regression, adjusting for demographic and clinical factors.

Results:

Five hundred sixty‐one patients (60.1% female, 69.0% Chinese; median age 49.0 years) were included. Diagnoses included rheumatoid arthritis (39.6%), psoriatic arthritis (26.6%), and spondyloarthritides (33.9%). Most (63.8%) were on tumor necrosis factor (TNF) inhibitors. SARS‐CoV‐2 infection occurred in 140 (25.0%) patients. Those infected had higher BMI (27.0 vs. 25.0 kg/m 2 , p = 0.005). BMI ≥ 23 kg/m 2 was independently associated with increased risk of infection (HR 1.63 [95% CI 1.05, 2.53]; p = 0.029). Severe COVID‐19 infection occurred in five patients. All were male, and four had underlying comorbidities. The underlying rheumatic diagnoses included rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis. These patients were receiving b/tsDMARDs including golimumab, tofacitinib, adalimumab biosimilar (Amgevita), and infliximab biosimilar (Remsima). Importantly, no deaths were reported.

Conclusion:

Being overweight or obese (BMI ≥ 23 kg/m 2 ) was independently associated with higher COVID‐19 infection risk. Severe infections were rare.

01 Feb 2026·MOLECULAR THERAPY

Extracellular cyclophilin a binding to CD146 is critical for Th17 cell differentiation in rheumatoid arthritis

Article

Author: Pei, Han Zhong ; Liu, Wenjun ; Yuhai Bi ; Lin, Runshan ; Yuna Zhao ; Tingrong Luo ; Jiao, Pengtao ; He Zhang ; Sun, Lei ; Heqiao Li ; Lei Sun ; Pengtao Jiao ; Bai, Xiaoyuan ; Yan, Xiyun ; Xiaoyuan Bai ; Han Zhong Pei ; Zhao, Yuna ; Zhang, He ; Luo, Tingrong ; Wenjun Liu ; Bi, Yuhai ; Li, Heqiao ; Yangtengyu Liu ; Xiyun Yan ; Runshan Lin ; Liu, Yangtengyu ; Hongxia Duan ; Fan, Zeqiu ; Duan, Hongxia ; Xiaoxiao Jia ; Zeqiu Fan ; Jia, Xiaoxiao

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint synovial inflammation. Despite advancements in therapeutic strategies, the critical underlying mechanisms driving RA progression remain incompletely understood, and there is an ongoing need for novel therapeutic targets. We observed that high-level expression of extracellular cyclophilin A (eCypA) in patients with RA was associated with increased disease severity. Anti-CypA monoclonal antibody (mAb) treatment alleviated arthritis in both collagen-induced and collagen antibody-induced arthritis mouse models, outperforming anti-TNF-α mAb therapy. Single-cell RNA sequencing revealed that the anti-CypA mAb inhibited STAT3-mediated Th17 cell differentiation. Mechanistically, the binding of eCypA to the cell-surface receptor CD146 on CD4⁺ T cells promoted STAT3-mediated Th17 cell differentiation by increasing CD146 dimerization. Additionally, conditional CD146 knockout in CD4⁺ T cells suppressed Th17 cell differentiation and alleviated arthritis in a mouse model. In summary, our findings demonstrate that eCypA drives Th17 differentiation in RA by binding to CD146 and that blocking eCypA binding to CD146 is a promising strategy for RA treatment.

105

News (Medical) associated with Infliximab-dyyb (Celltrion)

27 Jul 2026

·www.celltrion.com

Celltrion Reports Q2 2026 Revenue of KRW 1.3937Tn and Operating Profit of KRW 451.8Bn; Record Quarterly Revenue as New Product Growth and Cost Improvements Boost Profitability

- Revenue up 45% and operating profit up 86.3% YoY, with a 32.4% operating margin demonstrating solid growth. - High-margin new products grew 76% YoY, accounting for 65% of total biologics revenue. - COGS ratio improved by 5.4 percentage points YoY, reflecting continued improvement in profitability. - Operating margin above 30% was achieved despite continued investment in R&D for future growth. - The company aims to exceed its annual guidance, supported by major market tenders and continued expansion of newly launched products in the second half. INCHEON, South Korea – Celltrion today announced that it recorded consolidated revenue of KRW 1.3937 trillion and operating profit of KRW 451.8 billion for the second quarter of 2026. The results represent year-over-year (YoY) increases of 45% in revenue and 86.3% in operating profit. Following a record quarterly revenue performance in the first quarter, the company also achieved its highest-ever quarterly revenue in the second quarter. Operating margin improved by 7.2 percentage points from a year earlier to 32.4%, demonstrating both strong top-line growth and enhanced profitability. Compared with the preliminary earnings announced on July 3, revenue increased by KRW 93.7 billion and operating profit rose by KRW 21.8 billion. The latest results reflect more than just revenue growth, highlighting qualitative growth driven by a portfolio shift toward new products and improved manufacturing efficiency. Stable sales of key products, strong global sales growth of newly launched high-margin products, and faster-than-expected cost structure improvements contributed to the performance. The results also demonstrated a virtuous business cycle in which profits from commercialized products provide stable financial support for research and development investments to fuel future growth. ▲ High-Margin New Products Continue Strong Growth Across Major Markets, Accounting for 65% of Biologics Revenue Second-quarter growth was driven by the rapid expansion of high-margin new products[1], while key products including Remsima, Truxima, and Herzuma maintained solid market positions. Truxima ranked No. 1 in market share in the United States, supported by expanded long-term supply agreements, while Remsima maintained its leading position across key markets. Herzuma achieved a record-high market share of 78% in Japan and exceeded 30% market share in Europe. Revenue from new products increased 76% YoY, expanding their contribution to total biologics revenue to 65%. By product, Remsima SC surpassed a 32% market share across the EU5[2] markets, while Zymfentra, the U.S. brand of Remsima SC, has continued to see steady uptake since launch. Yuflyma maintained its leading position in the European adalimumab market and continued to gain market share in the United States through expanded supply capabilities and distribution networks. Vegzelma maintained its leadership position in Europe and strengthened its U.S. growth foundation through formulary listings by two major pharmacy benefit managers (PBMs). Combined quarterly revenue from five newly launched products — Eydenzelt, Avtozma, Omlyclo, Stoboclo and Osenvelt, and Steqeyma — whose global rollout accelerated last year, exceeded KRW 300 billion, up 49% from the previous quarter. Celltrion plans to increase the share of biologics revenue generated by new products to approximately 70% in the second half of the year by continuing to expand launches into additional markets and broaden approved indications. ▲ COGS Ratio Improves to 38%; Product Mix and Manufacturing Efficiency Accelerate Profit Growth The cost of sales ratio improved to 38%, down 5.4 percentage points YoY and 2.1 percentage points from the previous quarter. The improvement was driven by a more favorable product mix resulting from the growing contribution of high-margin new products, as well as enhanced cost competitiveness through the depletion of high-cost inventory, higher production yields, and process optimization. This led to the emergence of operating leverage, with operating profit growth significantly exceeding revenue growth. The company expects profitability improvement to accelerate further in the second half as continued top-line growth generates greater economies of scale, alongside more efficient SG&A spending. The profitability improvement reflects a structural change driven by a shift in revenue mix toward new products and enhanced manufacturing competitiveness, rather than one-off factors. As the contribution of new products continues to increase, the foundation for stable earnings growth is expected to strengthen further. ▲ Operating Margin Exceeds 30% After Recognizing R&D Expenses for Future Growth Celltrion's second-quarter performance was particularly noteworthy compared with previous quarters, as the company achieved a 32.4% operating margin despite recognizing R&D expenses related to future growth. Celltrion continues to invest in R&D—from the discovery of follow-on biosimilars and novel drug candidates to preclinical and clinical studies, regulatory approval, and commercialization—and recognizes the related costs in current-period earnings. Unlike manufacturing-focused business models, this structure entails maintaining the profitability of current products while simultaneously bearing the investment burden required for future pipeline development. Yet Celltrion delivered an operating margin exceeding 30%, demonstrating that the cash-generating capability and the competitiveness of its business provide strong support for continued R&D investment. Celltrion continues to strengthen a business model in which commercial success supports investment in the development of follow-on biosimilars and novel drug candidates, driving new product launches and revenue growth. This has led to growing recognition that the company's value should be assessed not only on its current profitability, but also on the value of its pipeline and long-term growth prospects supported by sustained R&D investment. ▲ Expanding Biosimilar and Novel Drug Pipeline to Strengthen Future Growth Drivers Building on the launch of 11 biosimilars globally as of last year, Celltrion is accelerating development of its next-generation pipeline. The company plans to build a portfolio of 18 products by 2030, including biosimilars referencing autoimmune disease treatments such as Ocrevus, Cosentyx, and Taltz, as well as oncology therapies such as Keytruda and Darzalex. Supported by the ongoing trend toward relaxed clinical requirements among regulatory authorities, certain follow-on products are expected to benefit from reduced patient enrollment requirements, shorter development timelines, and lower R&D costs. In novel drug development, the company continues to expand its novel drug portfolio through both in-house R&D and open innovation initiatives, with programs spanning antibody-drug conjugates (ADCs), multispecific antibodies, and obesity treatments. Leveraging the stable cash flows generated by its biosimilar business, Celltrion aims to accelerate its transformation into a global biopharmaceutical company by delivering tangible R&D outcomes from its novel drug pipeline. ▲ Stronger Second-Half Growth Expected; Company Aims to Exceed Full-Year Guidance Celltrion expects second-half growth to exceed first-half performance as supplies under major tender contracts increase and newly launched products continue to gain market share across key markets. Driven by new product expansion into additional markets, U.S. PBM formulary coverage, deliveries under European public tenders, and year-end inventory stocking by distributors, the company aims to exceed its full-year targets of KRW 5.3 trillion in revenue and KRW 1.8 trillion in operating profit. A Celltrion official said, “Our second-quarter results demonstrated Celltrion’s cash-generating capability and business competitiveness, as we achieved an operating margin exceeding 30% while continuing to invest in R&D for future growth.” The official added, “We will continue to reinvest the stable cash flows generated by our biosimilar business into follow-on products and novel drug development, with the goal of exceeding our full-year performance targets and enhancing long-term corporate value.” [1] New products: Remsima SC (marketed as Zymfentra in the U.S.), Yuflyma, Vegzelma, Steqeyma, Stoboclo·Osenvelt, Avtozma, Omlyclo, and Eydenzelt [2] EU5: Germany, Spain, the United Kingdom, Italy, France

Financial StatementADCBiosimilar

21 Apr 2026

·www.prnewswire.com

Celltrion to present seven abstracts in inflammatory bowel disease (IBD) at 2026 Digestive Disease Week® (DDW)

Seven abstracts accepted for presentation include data from long-term follow-up studies and a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA® (infliximab-dyyb) Findings emphasize clinical decision-making in long-term management of inflammatory bowel disease (IBD), reinforcing Celltrion's commitment to elevating the standard of care and addressing unmet medical need in gastroenterology April 21, 2026 -- Celltrion, Inc. today announced that seven abstracts will be presented at the 2026 Digestive Disease Week® (DDW) Annual Meeting, taking place May 2-5 in Chicago, Illinois. The oral and poster presentations will feature data including post-hoc analysis of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA®, the first and only FDA-approved subcutaneous infliximab. "The findings provide additional evidence that disease control can be effectively recaptured with a convenient subcutaneous option, with the potential to advance the treatment paradigm for people living with Crohn's disease and ulcerative colitis," said Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "The research Celltrion is presenting at DDW reflects our ongoing commitment to transforming IBD care through innovative therapies that improve patient outcomes." Celltrion is driving scientific discovery and expanding access to comprehensive clinical and real-world evidence to support informed treatment decisions in an increasingly complex and evolving IBD landscape. ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 2-5, 2026. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical Result

20 Mar 2026

·www.pharmamanufacturing.com

Celltrion signs biologics CMO deal, says backlog tops $680M

South Korea’s Celltrion announced a contract manufacturing organization agreement (CMO) with an undisclosed global pharmaceutical company to supply biologic drug substance from 2027 through 2029. According to the announcement, the contract is valued at approximately KRW 294.9 billion (about $200 million) and could increase to KRW 375.4 billion (about $255 million) subject to mutual agreement. Celltrion said it plans to finalize production arrangements early to ensure stable supply. The agreement follows continued momentum in Celltrion’s contract development and manufacturing organization (CDMO) business, including a previously announced contract with Eli Lilly. With the addition of the latest deal, the company said its cumulative CMO order backlog has exceeded KRW 1 trillion (about $680 million USD), reflecting increased demand for its manufacturing capabilities. In November 2025, Celltrion announced plans to expand its U.S. manufacturing capabilities with a $478 million investment in a recently acquired Eli Lilly facility in Branchburg, New Jersey. The expansion at the active pharmaceutical ingredient (API) plant will be rolled out in phases and is aimed at positioning the company to build an integrated U.S.-based manufacturing supply chain. Celltrion’s global manufacturing network includes facilities in Songdo, Incheon and Branchburg, New Jersey, totaling 316,000 liters of capacity. However, the company noted that expanding sales of its own products alongside growing CDMO demand is expected to increase pressure on available capacity, prompting evaluation of additional manufacturing investments. “Global sales of Celltrion’s own products, including Zymfentra, are expected to expand alongside the addition of new pipeline products,” the company said. “Consequently, a significant portion of existing production capacity is likely to be allocated to the manufacturing of Celltrion’s own products. At the same time, rapidly increasing CDMO demand from global pharmaceutical companies is further raising the need for additional manufacturing capacity in the mid- to long term.” Celltrion said it plans to continue expanding its CDMO services, including technology-driven offerings such as formulation conversion, while strengthening global project management and sales capabilities through its subsidiary Celltrion BioSolutions.

Acquisition

100 Deals associated with Infliximab-dyyb (Celltrion)

External Link

KEGG	Wiki	ATC	Drug Bank
D02598	-	L04AB02	DB00065

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Behcet Syndrome	Japan	Nippon Kayaku Co., Ltd.	18 Feb 2026
Behcet Syndrome	Japan	Celltrion Healthcare Japan KK	18 Feb 2026
Behcet's uveitis	Japan	Celltrion Healthcare Japan KK	01 Apr 2020
Behcet's uveitis	Japan	Nippon Kayaku Co., Ltd.	01 Apr 2020
Erythrodermic psoriasis	Japan	Nippon Kayaku Co., Ltd.	22 Jul 2015
Erythrodermic psoriasis	Japan	Celltrion Healthcare Japan KK	22 Jul 2015
Erythrodermic psoriasis	Japan	Celltrion, Inc.	22 Jul 2015
Psoriasis vulgaris	Japan	Celltrion Healthcare Japan KK	22 Jul 2015
Psoriasis vulgaris	Japan	Celltrion, Inc.	22 Jul 2015
Psoriasis vulgaris	Japan	Nippon Kayaku Co., Ltd.	22 Jul 2015
Pustular psoriasis	Japan	Celltrion, Inc.	22 Jul 2015
Pustular psoriasis	Japan	Nippon Kayaku Co., Ltd.	22 Jul 2015
Pustular psoriasis	Japan	Celltrion Healthcare Japan KK	22 Jul 2015
Ankylosing Spondylitis	European Union	Celltrion Healthcare Hungary Kft	10 Sep 2013
Ankylosing Spondylitis	European Union	Pfizer Europe MA EEIG	10 Sep 2013
Ankylosing Spondylitis	Iceland	Celltrion Healthcare Hungary Kft	10 Sep 2013
Ankylosing Spondylitis	Iceland	Pfizer Europe MA EEIG	10 Sep 2013
Ankylosing Spondylitis	Liechtenstein	Celltrion Healthcare Hungary Kft	10 Sep 2013
Ankylosing Spondylitis	Liechtenstein	Pfizer Europe MA EEIG	10 Sep 2013
Ankylosing Spondylitis	Norway	Pfizer Europe MA EEIG	10 Sep 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autoimmune Diseases	Preclinical	United Kingdom	Intract Pharma Ltd.	20 Aug 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04990258 (PEREM, Company_Website) Manual	Not Applicable	Inflammatory Bowel Diseases	136	subcutaneous infliximab (IV → SC switch)	wjxigvetss(hlqdsuinwo) = The switch from IV infliximab to SC infliximab is well tolerated amongst patients. jjpciaxjeg (tcgbxskyvq ) View more	Positive	06 Oct 2025
				subcutaneous infliximab + immunomodulator
NCT04205643 \| NCT03945019 (LIBERTY, Pubmed \| J Crohns Colitis)	Phase 3	Perianal fistula due to Crohn's disease \| Colitis, Ulcerative Maintenance	-	CT-P13 SC 120 mg	zdsfllcqlz(eftulblfgm) = lptfxfimvx dbfzfdxvpc (wskuhqcqog ) View more	Positive	04 Jun 2025
UEGW2024	Not Applicable	Inflammatory Bowel Diseases	-	CT-P13 SC 120 mg	plgnjxqgxw(jxuwudzlsv) = In UC, 84.7% (61/72) vs 78.1% (132/169), In CD, 86.8% (33/38) vs 79.7% (118/148) vszvsymhga (obdngkcngw ) View more	-	13 Oct 2024
				CT-P13 SC 240 mg
NCT02883452 (Pubmed \| Dig Liver Dis)	Phase 1	Inflammatory Bowel Diseases	112	CT-P13 SC maintenance group	kcnwlsqhps(quqdzxryxi) = Similar jpvrkxokqm (nvrdueohtw ) View more	Positive	01 Jul 2024
				IV-to-SC switch group
NCT04205643 \| NCT03945019 (Pubmed) Manual	Phase 3	Crohn Disease \| Inflammatory Bowel Diseases \| Colitis, Ulcerative Maintenance	-	CT-P13 SC 120 mg	siglbhomom(pjzwnpddlf) = uebbksqwln vspsviggyo (gfurwmxrko ) View more	Positive	23 May 2024
				Placebo	siglbhomom(pjzwnpddlf) = ahgwamggzg vspsviggyo (gfurwmxrko ) View more
ECCO2024	Not Applicable	Perianal fistula due to Crohn's disease	20	Subcutaneous IFX (CT-P13)	ittmzlmxai(qsseotpete) = cjmwqqokup lsclaeplgo (xfakcrquov ) View more	Positive	21 Feb 2024
LIBERTY-CD (ECCO2024)	Phase 3	Perianal fistula due to Crohn's disease Maintenance	180	CT-P13 SC	wnjmixbyrr(vhbgqbvgds) = There was no new safety issue reported during the extension phase. lbafqqnuxj (btyqcntzbc )	Positive	21 Feb 2024
NCT04205643 (LIBERTY-UC, ECCO2024)	Phase 3	Colitis, Ulcerative	237	CT-P13 SC	miychkxmxr(tkcupuwonp) = jdnebhkrbj bwnpyalxwv (bigflmcqod ) View more	Positive	21 Feb 2024
NEWS Manual	Phase 3	Crohn Disease \| Colitis, Ulcerative	-	CT-P13 SC (Crohn's disease)	fqpslccwwh(gorgtnvekt) = The recommended dose for subcutaneous infliximab is 120 mg once every 2 weeks eymefhexah (wbgutssjon ) View more	Positive	16 Oct 2023
				CT-P13 SC (ulcerative colitis)
UEGW2023	Not Applicable	Inflammatory Bowel Diseases	-	5 mg/kg every 8 weeks	bbzxgifrdc(jqcbgajrtp) = iikcfupqgb agqkvlkwqt (gfcmxfmfop ) View more	-	15 Oct 2023
				10 mg/kg every 8 weeks	bbzxgifrdc(jqcbgajrtp) = lglrrohykx agqkvlkwqt (gfcmxfmfop ) View more

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