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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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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A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
ClinicalTrials.gov

A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

People with IBD who are breastfeeding and are taking guselkumab may want data on how much of the drug gets into breast milk and the estimated infant exposure. This study aims to provide those measurements for the Q4W and...

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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

A new IL-23–targeting therapy (JNJ-78934804) is being tested against an approved IL-23 inhibitor (guselkumab) in a large Phase 3 trial for moderate–severe ulcerative colitis, which could affect future treatment options...

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A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

A new Phase 3 trial is testing icotrokinra, an oral investigational drug, for induction and maintenance of remission in moderate–severe ulcerative colitis. Trials like this could expand treatment options if the drug...

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Remote monitoring to improve engagement for patients with inflammatory bowel disease: a randomized clinical trial.
Crohn's & colitis 360

Remote monitoring to improve engagement for patients with inflammatory bowel disease: a randomized clinical trial.

Remote text monitoring is appealing as a low-cost way to support people with IBD on biologics, but this trial suggests it may not boost quality of life or adherence over 4 months when adherence is already high. Patients...

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The efficacy and safety of etrasimod as a first-line advanced therapy for ulcerative colitis: prespecified and post hoc subgroup data from the ELEVATE UC clinical program.
Therapeutic advances in gastroenterology

The efficacy and safety of etrasimod as a first-line advanced therapy for ulcerative colitis: prespecified and post hoc subgroup data from the ELEVATE UC clinical program.

This abstract reports that etrasimod improved multiple measures of disease activity versus placebo in patients who had inadequate response to conventional UC therapies, indicating it may be a useful first-line advanced...

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A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

A successful Phase 3 trial could add guselkumab — an IL-23–targeting biologic — as a treatment option for people with moderate to severe Crohn's disease, especially those who haven’t responded to prior therapies.

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Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis
ClinicalTrials.gov

Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis

This trial tests whether people with UC in deep remission can safely stop JAK inhibitor therapy — potentially reducing long-term exposure and associated safety concerns while preserving disease control and quality of...

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Corticosteroid-sparing effects of risankizumab versus ustekinumab in patients with moderately to severely active Crohn's disease: post hoc results from the phase 3b SEQUENCE trial.
Journal of Crohn's & colitis

Corticosteroid-sparing effects of risankizumab versus ustekinumab in patients with moderately to severely active Crohn's disease: post hoc results from the phase 3b SEQUENCE trial.

For people with moderate–severe Crohn’s disease who failed anti‑TNF drugs, this trial suggests risankizumab may achieve higher corticosteroid‑free clinical and endoscopic remission than ustekinumab, which could mean...

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Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
ClinicalTrials.gov

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

Combining a UC biologic (mirikizumab) with a weight-loss drug (tirzepatide) could address both intestinal inflammation and excess weight, which may be important for people with moderately to severely active ulcerative...

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A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
ClinicalTrials.gov

A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

This trial tests a common real-world question: switching from IV induction to subcutaneous vedolizumab maintenance in adults with moderate-to-severe UC or CD and measures short-term remission and longer-term treatment...

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Bowel Urgency in Ulcerative Colitis Is Associated With Clinical Endpoints, Health-Related Quality of Life, and Biomarkers: Data From the Etrasimod ELEVATE UC 52 Trial
Crohn's & Colitis 360

Bowel Urgency in Ulcerative Colitis Is Associated With Clinical Endpoints, Health-Related Quality of Life, and Biomarkers: Data From the Etrasimod ELEVATE UC 52 Trial

Bowel urgency is a common, disruptive UC symptom; this trial analysis shows urgency improvements with etrasimod track with clinical remission, endoscopic improvement, better quality of life, and lower inflammatory...

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Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis
ClinicalTrials.gov

Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis

This study will collect real-world data on adults with moderate-to-severe ulcerative colitis who start upadacitinib, tracking symptom remission and imaging response over one to two years — information that can help...

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A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

This trial is testing duvakitug as a maintenance treatment for people with moderately to severely active ulcerative colitis who responded to an earlier study, which could expand treatment options if later shown to be...

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Effect of physician prescribed information to the inflammatory bowel disease patients on quality of life and disease relapse: a randomised control trial
PubMed Central

Effect of physician prescribed information to the inflammatory bowel disease patients on quality of life and disease relapse: a randomised control trial

The study suggests that a physician-endorsed, librarian-developed information prescription may improve quality of life and reduce short-term relapse in people with IBD, a non-pharmacological approach that could be...

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A Single Arm, Multicenter Open-Label Interventional to Evaluate the Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose
ClinicalTrials.gov

A Single Arm, Multicenter Open-Label Interventional to Evaluate the Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose

This trial tests whether raising the upadacitinib dose to 45 mg can recapture clinical response in people with ulcerative colitis who lost response on the 30 mg maintenance dose. If effective and safe, the approach could...

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A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
ClinicalTrials.gov

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

This trial is testing an investigational anti-TL1A antibody (tulisokibart/MK-7240) as a potential new treatment for moderate to severe Crohn's disease. Results could affect future treatment options if the drug proves...

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