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Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis

Primary:* To prove the superiority of a 48-weeks treatment with 3.2 g/day delayedreleasephosphatidylcholine (LT-02) versus placebo for the maintenance ofremission in patients with ulcerative colitis (UC)Secondary:* To study safety and tolerability…

A randomised controlled trial comparing FMT (fecal microbiota transplantation) after budesonide or placebo in patients with active ulcerative colitis: ;Acronym: the FECBUD trial

To study the effect size of FMT after a 3 weeks course of budesonide as induction therapy in patients with active ulcerative colitis despite previous therapy. The purpose of the pre-treatment is to reduce active inflammation prior to donor feces…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn*s Disease (CARMEN CD 305)

Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…

Cyclic dietary calorie and protein restriction for induction of Inflammatory Bowel Disease

Primary objective: - To assess the efficacy of a calorie and protein restricted (CRPR) diet for induction of remission in IBD.Secondary objectives: - To assess the feasibility of a CRPR diet in IBD patients.- To assess the effect of a CRPR diet on…

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis

To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

The objective of this Phase 3 study is to investigate the safety and efficacy of benralizumab as a treatment for patients with eosinophilic gastritis and/or gastro-enteritis.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Investigate The Efficacy And Safety Of Mongersen (GED-0301) For The Treatment Of Adult and Adolescent Subjects With Active Crohn*s Disease

To evaluate the efficacy of GED-0301 at Week 12, administered as either a single 160 mg tablet or as four 40 mg tablets, compared with placebo on clinical activity in subjects with active CD

A randomized, double-blind, placebo-controlled, multicenter, phase 2a study to evaluate the safety, tolerability, and early proof of concept of TAK-018 for the prevention of postoperative Crohn*s disease recurrence.

Primary Objective:to assess the safety and tolerability of TAK-018 in postoperative subjects with CD afterlaparoscopic ileocecal resection with primary anastomosis.Secondary Objectives:to evaluate the impact of TAK-018 on intestinal inflammation…

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn*s disease with an option for open-label treatment extension (CALDOSE-2)

Primary objective• To determine the optimal dose of IMU-838 to induce symptomatic remission (based on stool frequency [SF] and abdominal pain [AP], as assessed in the Crohn*s Disease Activity Index [CDAI] patient reported outcome [PRO]-2) in…

Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis

The primary objective of this randomized controlled trial is to investigate the efficacy of dashboard driven dosing of infliximab compared to standard dosing during the induction phase in patients with acute severe ulcerative colitis, as evaluated…

A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis

To evaluate the efficacy based on the histological response

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

This study has been transitioned to CTIS with ID 2023-504736-18-00 check the CTIS register for the current data. Primary Objectives (Phase 2 and Phase 3):- To evaluate the clinical efficacy of guselkumab in participants with Crohn*s disease- To…

De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring

To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.

Mindfulness-based cognitive therapy to improve stress and reduce sleep in patients with inflammatory bowel disease

Does Mindfulness-Based Cognitive Therapy (MBCT) reduce psychological distress and improve sleep quality and quality of life compared to treatment as usual (TAU) in patients with IBD?

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn*s Disease

Main objective:*To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active Crohn's disease (CD).*To select an oral etrasimod dose, based on efficacy and…

A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects with Active Crohn*s Disease (Serenity)

Primary objective: To test the hypothesis that treatment with LY3074828 is superior to placebo in the proportion of subjects with endoscopic response at Week 12, defined as 50% reduction from baseline in SES-CD ScoreSecondary objective: • To…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease

MAIN Trial:Primary:To evaluate whether the efficacy of mirikizumab is superior to placebo in participants with Crohn's disease as assessed by- clinical response by patient reported outcome (PRO) at Week 12 andendoscopic response at Week 52-…

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Primary Objectives* To evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo score,in pediatric participants with moderately to severely active ulcerative colitis (UC).* To evaluate the safety profile of golimumab…

Pragmatic randomised controlled study to assess the effectiveness of two patient management
strategies in mild-to-moderate Ulcerative Colitis

The purpose of this pragmatic randomised controlled study is to compare two patient management strategies in mild-to-moderate UC disease. The goal of the study is to propose a new patient management strategy to both physicians and patients, as an…

Top-Down Infliximab Study in Kids with Crohn's disease (TISKids)

The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD. Secondary objectives are determination of the pharmacokinetic/-dynamic profile of IFX and finding predictors of…