Fluorescence imaging of a new drug for inflammatory bowel disease
Investigating the Safety, Feasibility, and Optimal Dose of Fluorescently Labeled Adalimumab-680LT for Visualizing Drug Targeting in Inflammatory Bowel Diseases
This study is testing a new version of a drug for inflammatory bowel disease to see how safe it is and how well it works in helping patients with Crohn's Disease and Ulcerative Colitis.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | adalimumab |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06117423 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and optimal dosing of a fluorescently labeled version of adalimumab, known as adalimumab-680LT, in patients with Crohn's Disease and Ulcerative Colitis. The goal is to visualize and quantify the local concentration of the drug using fluorescence molecular imaging, which may help predict treatment response. Patients eligible for adalimumab therapy and with active disease will be included, and the study will involve both in vivo and ex vivo imaging techniques. The research is being conducted at the University Medical Center Groningen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with an established diagnosis of Crohn's Disease or Ulcerative Colitis and active disease.
Not a fit: Patients who are pregnant, breastfeeding, or have recently undergone anti-TNF therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of treatment responses for patients with inflammatory bowel disease.
How similar studies have performed: While the use of fluorescence imaging in this context is novel, similar approaches in other areas have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Established IBD diagnosis (UC or CD) * Active disease (clinically defined as at least mild activity using dedicated scoring indices and biochemically defined by a fecal calprotectin \> 60 µg/g, measured within the last 6 weeks before inclusion) * Patients must be eligible for adalimumab therapy * Clinical indication for an endoscopic procedure * Age: 18 years or older * Written informed consent * For female patients of premenopausal age with intact reproductive organs or who are less than 2 years postmenopausal, a negative pregnancy test must be available. Exclusion Criteria: * Pregnancy or breast feeding * Female patient of premenopausal age who does not use any reliable form of contraception at the time of adalimumab-680LT administration and the following 10 weeks. * Medical or psychiatric conditions that compromise the patient's ability to give informed consent * Prior anti-TNF therapy in the last 6 weeks before inclusion * Active extra gastrointestinal manifestations of Crohn's disease * Previous treatment with adalimumab and detectable anti-adalimumab antibodies levels
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Wouter B Nagengast, MD, PhD, PharmD
- Email: w.b.nagengast@umcg.nl
- Phone: +31(0)503612620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.