Evidence types

Phase 3 clinical trial

Phase 3 clinical trial articles covering late-stage treatment evidence, safety, effectiveness, and regulatory context in IBD. Research context emphasizes studies, trials, biomarkers, mechanisms, and emerging IBD science.

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Long-term outcomes of top-down therapy versus a conventional step-up strategy in adults newly diagnosed with Crohn's disease: 5-year follow-up of the PROFILE trial.
The lancet. Gastroenterology & hepatology

Long-term outcomes of top-down therapy versus a conventional step-up strategy in adults newly diagnosed with Crohn's disease: 5-year follow-up of the PROFILE trial.

If confirmed, starting anti‑TNF therapy (infliximab) early plus an immunomodulator may reduce surgeries, hospital admissions, and progression to complicated disease behavior over 5 years compared with a traditional...

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A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov

A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease

This trial is testing risankizumab in children with moderate-to-severe Crohn’s disease to learn how the drug behaves in kids, whether it’s safe, and whether it reduces disease activity — information that could expand...

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A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov

A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease

This trial studies adalimumab safety and pediatric dosing in children with moderate–severe Crohn's disease, which is directly relevant to families and clinicians considering anti-TNF therapy for pediatric IBD.

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Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
ClinicalTrials.gov

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

This trial describes a large Phase 3 extension study collecting long-term safety and tolerability data for tulisokibart (MK-7240), an investigational TL1A-targeting antibody for Crohn’s disease and ulcerative colitis....

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An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis
ClinicalTrials.gov

An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis

Long-term, real-world safety data help patients and clinicians understand risks — especially serious infections — when a newer ulcerative colitis drug is used in routine practice. This registry entry shows Pfizer is...

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Targeting the TL1A pathway in inflammatory bowel disease: mechanistic insights and emerging therapeutic pipeline.
Inflammatory bowel diseases

Targeting the TL1A pathway in inflammatory bowel disease: mechanistic insights and emerging therapeutic pipeline.

Anti‑TL1A drugs represent a new mechanism with phase 2 signals for clinical remission and endoscopic response in both UC and Crohn's disease, plus early biomarker evidence suggesting antifibrotic effects—areas directly...

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A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
ClinicalTrials.gov

A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany

This study will gather real‑world effectiveness and patient‑reported outcome data for guselkumab in adults with moderate‑to‑severe Crohn’s disease or ulcerative colitis, which may help clinicians and patients understand...

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A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
ClinicalTrials.gov

A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

Patients and clinicians considering guselkumab for Crohn’s disease or ulcerative colitis may gain real-world evidence on how the drug performs across treatment lines and subgroups over up to 96 weeks. The study will...

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A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3 testing of guselkumab (an IL-23–targeting biologic) in moderately to severely active ulcerative colitis could expand treatment options if the trial meets its endpoints and shows an acceptable safety profile. The...

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ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
ClinicalTrials.gov

ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery

Pouchitis is a common, sometimes chronic complication after IPAA surgery for ulcerative colitis and can substantially affect quality of life. If topical 5-ASA prevents pouchitis, it could offer a simple prophylactic...

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Efficacy, Safety, and Pharmacokinetics of Upadacitinib Among Patients in East Asia With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Subanalysis of Randomized Phase 3 Studies
Journal of Gastroenterology and Hepatology

Efficacy, Safety, and Pharmacokinetics of Upadacitinib Among Patients in East Asia With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Subanalysis of Randomized Phase 3 Studies

This analysis suggests upadacitinib works and has a similar safety and pharmacokinetic profile in East Asian patients with moderately to severely active ulcerative colitis as in the global trials, which may reassure...

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Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis

A new Phase 3 trial is testing ponesimod, an oral S1P-modulator, for moderately to severely active ulcerative colitis — this could expand oral treatment options if later shown effective and safe.

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Living well with Crohn’s & Colitis fatigue, pain and urgency/faecal incontinence: the IBD-BOOST research programme including an RCT
Europe PMC

Living well with Crohn’s & Colitis fatigue, pain and urgency/faecal incontinence: the IBD-BOOST research programme including an RCT

Many people with IBD experience persistent fatigue, pain and faecal incontinence even when inflammation is controlled; this programme tested a supported online self-management approach to help those symptoms and assessed...

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A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
ClinicalTrials.gov

A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

Patients and clinicians are interested in whether combining two targeted biologic therapies can induce stronger endoscopic healing for people with difficult-to-treat Crohn's disease, and whether benefit can be maintained...

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A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
ClinicalTrials.gov

A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis

A new pediatric Phase 3 trial of filgotinib could broaden approved treatment choices for children and teens with moderate-to-severe ulcerative colitis, especially for those who have not responded to or cannot tolerate...

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The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients the Patient Will be Recruited From Outpatient Clinic of IBD and Gastroenterology of the National Hepatology and Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.
ClinicalTrials.gov

The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients the Patient Will be Recruited From Outpatient Clinic of IBD and Gastroenterology of the National Hepatology and Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.

The trial tests two low-cost adjuncts — a Lactobacillus probiotic and a multi–trace-element supplement — added to biologic-based standard care to see if they help maintain remission in ulcerative colitis. If effective,...

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Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis
ClinicalTrials.gov

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

Faecal microbiota transfer is being tested in a large Phase 3 trial as a possible new treatment approach for active ulcerative colitis, and this study also looks at safety and how the therapy changes the gut microbiome...

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A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
ClinicalTrials.gov

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

This trial is testing whether continued mirikizumab treatment helps children and teens with ulcerative colitis or Crohn’s disease achieve and maintain remission over the long term. Results could expand pediatric...

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Anti-TNF withdrawal or long-term treatment in ulcerative colitis (BIOSTOP): a multicentre open label, randomized controlled trial.
Journal of Crohn's & colitis

Anti-TNF withdrawal or long-term treatment in ulcerative colitis (BIOSTOP): a multicentre open label, randomized controlled trial.

This trial directly informs a common clinical question: whether patients in deep remission can safely stop anti‑TNF therapy. Results show higher relapse risk after withdrawal, but many patients can be successfully...

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Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
ClinicalTrials.gov

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

People with Crohn’s disease who are overweight or have obesity may have different disease and treatment needs. This Phase 3 trial is testing whether adding tirzepatide to mirikizumab improves both disease outcomes and...

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