Ongoing Clinical Trials for Inflammatory Bowel Disease
There are currently 10 clinical trials investigating various treatment approaches for inflammatory bowel disease, including studies on medications like mirikizumab, infliximab, and vedolizumab. These trials are exploring new treatment options, dosing strategies, and therapeutic approaches for both adults and children with conditions such as Crohn’s disease and ulcerative colitis across multiple European countries.
Clinical trial locations
- Austria
- Belgium
- Study of Mirikizumab for Children and Teens with Moderate-to-Severe Ulcerative Colitis or Crohn’s Disease
- Study on Pain Relief Using Lidocaine and Sodium Chloride in Patients with Chronic Inflammatory Bowel Disease and Abdominal Pain
- Study on Subcutaneous Infliximab for Patients with Ulcerative Colitis, Crohn’s Disease, or Unclassified Inflammatory Bowel Disease
- France
- Germany
- Italy
- Netherlands
- Study of Mirikizumab for Children and Teens with Moderate-to-Severe Ulcerative Colitis or Crohn’s Disease
- Study on the Safety and Imaging of Adalimumab-680LT for Patients with Inflammatory Bowel Disease
- Study on the Safety and Imaging of Risankizumab-800CW for Patients with Inflammatory Bowel Disease
- Study Comparing Infliximab Alone or with Immunosuppressive Drugs for Moderate to Severe Crohn’s Disease Patients
- Title: Study of vedolizumab dose adjustment guided by drug level monitoring in patients with inflammatory bowel disease in remission
- Poland
- Spain
- Sweden
Study of Mirikizumab for Children and Teens with Moderate-to-Severe Ulcerative Colitis or Crohn’s Disease
This trial is investigating mirikizumab for children and adolescents with moderate to severe ulcerative colitis or Crohn’s disease. The study is designed as a long-term extension to evaluate the ongoing safety and effectiveness of this medication.
Who can participate: Children and adolescents who have completed previous related studies and continue to receive mirikizumab can join. Female participants must follow specific contraception requirements during the study. The trial is open to boys and girls who are considered a vulnerable group requiring extra protection.
Who cannot participate: Specific exclusion criteria were not detailed, but standard considerations would apply for children enrolled in therapeutic trials.
Study goals: The primary goal is to evaluate the effectiveness of mirikizumab in achieving clinical remission in participants. For ulcerative colitis, success is measured using the Modified Mayo Score at Week 52. For Crohn’s disease, the Pediatric Crohn’s Disease Activity Index is used at Week 52 to assess clinical remission.
Medication being tested: Mirikizumab is administered as a solution for injection or infusion. This monoclonal antibody targets and inhibits a specific protein involved in the inflammatory process, helping to reduce inflammation in the gut.
Study on Pain Relief Using Lidocaine and Sodium Chloride in Patients with Chronic Inflammatory Bowel Disease and Abdominal Pain
This Belgian trial focuses on pain management for patients with chronic conditions like Crohn’s disease and ulcerative colitis who experience ongoing abdominal pain.
Who can participate: Adults aged 18 or older with stable inflammatory bowel disease who experience abdominal pain scoring greater than 3 at least two days per week can join. Participants must have had no changes in their treatment for the past three months and be able to communicate in French.
Who cannot participate: Patients without an inflammatory bowel disease diagnosis, those under 18 or over 65, pregnant or breastfeeding women, people with lidocaine allergies, and those who participated in another trial within 30 days are excluded.
Study goals: The trial aims to determine if lidocaine infusion can reduce pain intensity by at least 50%. Researchers will also examine changes in brain connectivity to understand how lidocaine works in patients compared to healthy volunteers.
Medication being tested: Lidocaine hydrochloride monohydrate, administered through intravenous infusion. This local anesthetic blocks sodium channels in nerve cells to prevent pain signal transmission.
Study on Prednisolone Transfer into Breast Milk and Infant Plasma for Mothers with Rheumatoid Arthritis and Other Inflammatory Conditions
This Swedish study examines how prednisolone, an anti-inflammatory medication, passes into breast milk and infant blood when taken by breastfeeding mothers.
Who can participate: Breastfeeding women aged 18 or older taking prednisolone doses up to 50 mg per day can participate. Both the mother and the father of the child must sign informed consent forms.
Who cannot participate: Men cannot participate as this study specifically focuses on breastfeeding women and their infants. Only women with conditions requiring prednisolone treatment are eligible.
Study goals: The study measures prednisolone concentrations in breast milk and maternal blood one hour after medication intake, and in infant blood two hours after breastfeeding. Researchers will also measure cortisol levels in the infant’s blood to assess any effects on natural hormone production.
Medication being tested: Prednisolone, a glucocorticoid medication taken orally, used to reduce inflammation in various conditions including inflammatory bowel disease, rheumatoid arthritis, and lupus.
Study on the Safety and Imaging of Adalimumab-680LT for Patients with Inflammatory Bowel Disease
This Dutch trial investigates a special fluorescently labeled version of adalimumab to help visualize how the drug targets inflammation in the body.
Who can participate: Adults aged 18 or older with confirmed inflammatory bowel disease (ulcerative colitis or Crohn’s disease) showing active disease can join. Participants must have fecal calprotectin levels greater than 60 µg/g within the last six weeks and be eligible for adalimumab treatment.
Who cannot participate: People with severe allergic reactions to similar medications, active infections, pregnancy or breastfeeding, recent participation in other trials, cancer history (except certain skin cancers), significant heart, liver or kidney problems, recent vaccinations, or substance abuse history are excluded.
Study goals: The trial evaluates the safety of adalimumab-680LT by monitoring vital signs and adverse reactions. It also investigates how well fluorescence molecular endoscopy can detect the drug and determine the optimal imaging dose.
Medication being tested: Adalimumab-680LT, a fluorescently labeled version of adalimumab administered as a subcutaneous injection. This biologic medication blocks tumor necrosis factor-alpha to reduce inflammation.
Study on the Safety and Imaging of Risankizumab-800CW for Patients with Inflammatory Bowel Disease
Another Dutch imaging study, this trial uses fluorescently labeled risankizumab to visualize drug targeting in inflammatory bowel disease.
Who can participate: Adults aged 18 or older with confirmed active ulcerative colitis or Crohn’s disease can participate. Eligible participants must have fecal calprotectin greater than 60 µg/g and be suitable for risankizumab therapy. Female participants of childbearing potential must have a negative pregnancy test.
Who cannot participate: Similar exclusions apply as in the adalimumab imaging study, including active infections, pregnancy, recent trial participation, and significant organ dysfunction.
Study goals: The study assesses the safety of risankizumab-800CW through vital sign monitoring and evaluates the feasibility of using fluorescence molecular endoscopy to detect medication signals and determine optimal imaging doses.
Medication being tested: Risankizumab-800CW, administered through intravenous infusion. This monoclonal antibody targets specific proteins involved in inflammation.
Study Comparing Infliximab Alone or with Immunosuppressive Drugs for Moderate to Severe Crohn’s Disease Patients
This Dutch trial compares using infliximab alone versus combining it with other immunosuppressive medications for moderate to severe Crohn’s disease.
Who can participate: Adults aged 18 or older with diagnosed Crohn’s disease showing moderate to severe activity (CDAI score between 220-450) can join. Participants must show objective inflammation evidence through endoscopy and either not responded to previous treatments or be deemed suitable for immediate infliximab therapy.
Who cannot participate: People with other serious health conditions interfering with the study, current participation in another trial, recent or planned surgery, pregnancy or breastfeeding, severe allergies, active infections, recent cancer history, substance abuse, or inability to follow study procedures are excluded.
Study goals: At week 26, the trial evaluates whether participants achieve corticosteroid-free clinical remission (CDAI score less than 150) and endoscopic response (at least 50% reduction in inflammation score).
Medication being tested: Infliximab administered as subcutaneous injection via pre-filled pen, with or without additional immunosuppressive medications.
Study on How Gut Bacteria Affect Energy Use in Cells for Healthy Adults and Patients with Inflammatory Bowel Disease Using Amphotericin B, Vancomycin, and Gentamicin Sulfate
This French study investigates how gut bacteria influence energy metabolism in immune cells, comparing healthy adults with patients in remission.
Who can participate: Healthy adults and patients with Crohn’s disease or ulcerative colitis aged 18-50 with BMI between 17-25 can participate. Patients must be in steroid-free remission for at least six months with regular bowel movements. Women of childbearing age must use active contraception.
Who cannot participate: People with gastrointestinal disease history (for healthy volunteers), current inflammatory bowel disease symptoms, or those not in remission (for patients) cannot participate.
Study goals: The trial evaluates how gut microbiota changes affect immune cell energy metabolism. Researchers use labeled inulin to track nutrient processing and analyze blood and fecal samples to identify bacteria responsible for metabolizing the marker.
Medication being tested: The study involves oral administration of antibiotics (Gentamicin, Amphotericin B, and Vancomycin) and uses fecal microbiota transplantation and probiotic supplements to modify gut bacteria composition.
Study on the Effectiveness of Infliximab for Children with Inflammatory Bowel Disease
This Italian study examines infliximab effectiveness in children and adolescents, comparing standard dosing with an approach that adjusts treatment based on drug level monitoring.
Who can participate: Children and teenagers aged 6-17 with confirmed inflammatory bowel disease diagnosis through endoscopic biopsy can join. Participants must have active inflammation (CRP greater than 5 mg/L or fecal calprotectin greater than 150 µg/g) and need to start anti-TNF therapy according to current guidelines.
Who cannot participate: Children who previously received anti-TNF medications or those with serious health conditions interfering with the study, active infections, pregnancy or breastfeeding (for older adolescents), recent surgery plans, allergies to the study medication, drug or alcohol abuse, recent cancer, heart problems, uncontrolled blood pressure, liver or kidney disease, blood disorders, or uncontrolled mental health conditions are excluded.
Study goals: The trial assesses infliximab’s long-term effectiveness over approximately one year, examining whether proactive drug level monitoring improves outcomes compared to standard dosing schedules.
Medication being tested: Infliximab, administered through intravenous infusion. This biologic medication blocks tumor necrosis factor-alpha to reduce inflammation in the digestive tract.
Study of Vedolizumab Dose Adjustment Guided by Drug Level Monitoring in Patients with Inflammatory Bowel Disease in Remission
This Dutch trial investigates whether adjusting vedolizumab doses based on blood level monitoring can be more cost-effective while maintaining disease control.
Who can participate: Adults aged 18-64 with Crohn’s disease or ulcerative colitis in remission can participate. Participants must be receiving subcutaneous vedolizumab and willing to follow drug monitoring schedules.
Who cannot participate: People under 18 or over 65, those not in remission, with active infections, pregnancy or breastfeeding, previous allergic reactions to vedolizumab, severe liver or kidney disease, recent cancer, major surgery within three months, recent participation in other trials, inability to provide consent, history of non-compliance, or contraindications to subcutaneous injections are excluded.
Study goals: The 48-week trial compares standard fixed dosing with adjusted dosing based on therapeutic drug monitoring. The goal is to determine if dose adjustment can be more cost-effective while maintaining the same treatment benefits.
Medication being tested: Vedolizumab (Entyvio), administered as subcutaneous injection using pre-filled syringes containing 108 mg. This integrin receptor antagonist blocks proteins causing inflammation by preventing inflammatory cells from entering gut tissue.
Study on Subcutaneous Infliximab for Patients with Ulcerative Colitis, Crohn’s Disease, or Unclassified Inflammatory Bowel Disease
This Belgian trial examines switching patients from intravenous to subcutaneous infliximab administration, comparing weekly versus every-other-week dosing.
Who can participate: Adults aged 18 or older with confirmed Crohn’s disease, ulcerative colitis, or unclassified inflammatory bowel disease in steroid-free clinical and biological remission can join. Participants must have received intravenous infliximab for at least 26 consecutive weeks on a stable schedule and be able to communicate in Dutch, French, or English.
Who cannot participate: Patients not in clinical or biological remission, those not on an optimized intravenous schedule before switching, or members of vulnerable populations are excluded.
Study goals: The 52-week trial assesses the proportion of patients maintaining steroid-free remission without treatment optimization by week 52. It also evaluates patient satisfaction with subcutaneous therapy and monitors any side effects.
Medication being tested: Infliximab administered subcutaneously either weekly or every other week. This monoclonal antibody blocks tumor necrosis factor-alpha to reduce inflammation in the digestive tract.
Summary
These 10 ongoing clinical trials demonstrate diverse approaches to treating inflammatory bowel disease across Europe. The Netherlands leads with five trials, followed by Belgium with three, while France, Italy, and Sweden each host two trials. Multiple countries collaborate on the mirikizumab pediatric study spanning nine nations.
A notable trend is the focus on biologic medications, particularly infliximab and related therapies, appearing in six trials. Several studies explore innovative approaches such as fluorescent labeling for visualization, therapeutic drug monitoring for dose optimization, and switching from intravenous to subcutaneous administration for patient convenience.
The trials address both adult and pediatric populations, with special attention to children and adolescents in two studies. Research ranges from pain management strategies to understanding gut bacteria’s role in disease, reflecting the complexity of treating these conditions. The emphasis on maintaining remission while optimizing treatment costs and convenience suggests a shift toward personalized, sustainable long-term management approaches.
