Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid
Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
Participant gender:
Summary
In the clinical trial the investigators will assess efficacy, safety and tolerability after
single and multiple doses of 3 millimolar 5 aminolevulinic acid (Gliolan®) in combination
with blue-light (405 nanometer) or red-light (630 nm) photopheresis in patients with active
crohns disease. The study is a proof-of-concept pilot with 10 included patients where every
patient will get active treatment. The first 5 patients will receive blue light and the
remaining 5 patients will receive red light. The use of 5-aminolevulinic acid in combination
with blue-light and red-light photopheresis is a first-in-human trial. Primary endpoints
include clinical response and adverse events (safety). Secondary endpoints include endoscopic
improvement, quality of life questionnaires, faecal calprotectin, C-reactive protein and
mechanisms of action (differences in t-cells and other cells before and after treatment). All
patients will get treatment every 2 weeks for 10 weeks (6 treatments-induction) with
evaluation at week 13. If any effect on week 13 eligible for study extension with treatment
every 4 weeks for up to 12 months. Through the study the investigators will see if this kind
of photopheresis is safe and can be an option for a larger randomized-controlled-trial. In
addition the investigators will see if photopheresis as an option can be further developed
for other diseases as well (ie other T-cell mediated diseases or patients already receiving
photopheresis as a treatment).