Evidence types

Phase 2 clinical trial

Phase 2 clinical trial articles covering treatment signals, dosing, safety, and mid-stage IBD research.

Page 4 of 5 · 234 articles

Emerging insights into TL1A biology may guide precision therapy for IBD.
The Journal of experimental medicine

Emerging insights into TL1A biology may guide precision therapy for IBD.

TL1A-blocking antibodies have shown promising response rates in early trials for both Crohn's disease and ulcerative colitis. Understanding TL1A biology could help match new therapies to the patients most likely to...

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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

This registered Phase 2/3 program is evaluating guselkumab (an IL‑23 inhibitor) for moderate–severe Crohn's disease and could expand treatment options if trials show benefit and safety. The studies include clinical and...

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Modified Crohn's Disease Exclusion Diet and exclusive enteral nutrition (EEN) resolve oral dysbiosis in pediatric Crohn's disease: a prospective cohort study
PubMed Central

Modified Crohn's Disease Exclusion Diet and exclusive enteral nutrition (EEN) resolve oral dysbiosis in pediatric Crohn's disease: a prospective cohort study

The oral microbiome in children with Crohn's disease appears to reflect disease severity and changes with treatment, suggesting a potential noninvasive biomarker for monitoring response to nutritional therapies like CDED...

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

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

This registered Phase 2 trial tests guselkumab, golimumab, and a new investigational agent (JNJ-78934804) in adults with moderate–severe ulcerative colitis who previously failed advanced therapies. Results could affect...

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An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
ClinicalTrials.gov

An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

Long-term safety data on biologics and thiopurines are important for people with ulcerative colitis because they help patients and clinicians weigh risks (including malignancies and pregnancy-related outcomes) when...

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Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease
ClinicalTrials.gov

Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease

This trial tests whether pomegranate juice can lower fecal calprotectin, a commonly used marker of intestinal inflammation, in people with IBD in remission. If effective, such a dietary approach could be of interest to...

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STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
ClinicalTrials.gov

STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP

The study tests whether adding MRI-based transmural assessment to a fecal-calprotectin–guided (CALM) strategy improves the ability to keep people with Crohn’s disease in corticosteroid-free clinical remission and may...

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The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
ClinicalTrials.gov

The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC

A new Phase 2 study is testing an investigational injectable drug (called “627”) for moderate to severe ulcerative colitis. People with UC who have not responded to or cannot tolerate current therapies are the intended...

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Diagnostic accuracy of magnetic resonance enterography and intestinal ultrasound for treatment response assessment in Crohn's disease (MANTRA): protocol for a multicentre, non-randomised, multiple-arm, prospective cohort comparison study.
BMJ open

Diagnostic accuracy of magnetic resonance enterography and intestinal ultrasound for treatment response assessment in Crohn's disease (MANTRA): protocol for a multicentre, non-randomised, multiple-arm, prospective cohort comparison study.

This study could clarify which imaging test—MRE or IUS—is more accurate or appropriate for monitoring treatment response in Crohn's disease, potentially standardising follow-up and informing patient and clinician...

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Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.
ClinicalTrials.gov

Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.

This trial is testing guselkumab (an IL‑23 inhibitor) in a real‑world UC cohort and will measure endoscopic and histologic remission at 48 weeks — outcomes that matter to people managing moderate‑to‑severe ulcerative...

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A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
ClinicalTrials.gov

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

This trial explores whether oral ozanimod can induce and maintain remission in children and adolescents with moderate to severe ulcerative colitis who have not responded to standard therapies. Pediatric-specific evidence...

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Development and External Validation of a Machine Learning Model for Pre-Endoscopic Prediction of Montreal Disease Extent (E1/E2/E3) in Ulcerative Colitis Using Symptoms, Signs, and Laboratory Tests: A Multicenter Retrospective Observational Study
ClinicalTrials.gov

Development and External Validation of a Machine Learning Model for Pre-Endoscopic Prediction of Montreal Disease Extent (E1/E2/E3) in Ulcerative Colitis Using Symptoms, Signs, and Laboratory Tests: A Multicenter Retrospective Observational Study

A validated pre-endoscopic model could help estimate UC disease extent before colonoscopy, aiding clinical triage and planning without replacing endoscopy.

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Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy(PRECAL)
ClinicalTrials.gov

Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy(PRECAL)

If validated, an early drop in fecal calprotectin could help identify patients on biologic therapy who are likely to achieve mucosal healing without waiting for invasive endoscopy, allowing earlier decisions about...

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A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)
ClinicalTrials.gov

A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)

This Phase 2a trial tested a new investigational drug, tulisokibart, in people with moderately to severely active Crohn’s disease who have not done well on prior therapies — so patients and clinicians watching new...

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Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
ClinicalTrials.gov

Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

An LTE Phase 2 study offers longer-term safety monitoring and continued access to investigational long-acting antibody drugs for people who completed or met escape criteria in the parent SKYLINE-UC trial; that can matter...

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A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

This trial tests an oral integrin α4β7 inhibitor for Crohn’s disease, a new small-molecule approach aiming to block gut-specific immune cell trafficking similar to existing biologic anti‑integrin drugs. If effective and...

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A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

This trial tests two investigational agents (eltrekibart and mirikizumab) for moderate–severe ulcerative colitis, which may offer additional treatment options if proven safe and effective. It’s relevant to people whose...

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A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov

A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis

This trial tests an investigational oral therapy (D-2570) specifically in moderate–severe ulcerative colitis with a standard clinical remission endpoint at 12 weeks. Results could inform new treatment options if later...

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LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
ClinicalTrials.gov

LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

This trial tests whether adding an investigational oral agent (LY4268989) to mirikizumab improves remission rates in people with moderately to severely active ulcerative colitis. If successful, it could expand treatment...

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A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
ClinicalTrials.gov

A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

This trial tests whether adding an FXR agonist (LY4395089) to mirikizumab improves endoscopic response in people with moderate–severe Crohn's disease. Results could influence future combination treatment strategies and...

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Efficacy and safety of duvakitug in patients with ulcerative colitis (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial.
The lancet. Gastroenterology & hepatology

Efficacy and safety of duvakitug in patients with ulcerative colitis (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial.

A new biologic (duvakitug) targeting TL1A showed higher clinical remission at 14 weeks than placebo in a phase 2b trial of adults with moderately to severely active ulcerative colitis, which could expand future treatment...

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A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

This trial tests several investigational long-acting antibody treatments (as monotherapies and combinations) for adults with moderate to severe ulcerative colitis using histologic and clinical remission endpoints —...

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