Dual wavelength fluorescence imaging using fluorescently labelled adalimumab and risankizumab for visualizing drug targeting in Inflammatory Bowel Diseases (VOYAGER)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Immune System Diseases [C20]

Trial duration

8 May 2026 → ongoing

Decision date (initial)

2026-01-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University Medical Center Groningen

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To investigate the feasibility of the Windu system to use dual tracer fluorescence molecular endoscopy (FME) and ex vivo FMI to detect adalimumab-680LT and risankizumab-800CW signals.

Secondary objectives 4

1. To investigate a potential correlation of in vivo and ex vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of adalimumab/risankizumab therapy regimen in patients with IBD
2. To quantify the fluorescence signals of the tracers in vivo by using single-fiber reflectance/single-fiber fluorescence (MDSFR/SFF) spectroscopy and correlate these measurements to inflammation severity
3. To evaluate the adalimumab-680LT and risankizumab-800CW distribution inside mucosal biopsies
4. To identify the composition of immune cells in the mucosal microenvironment of IBD patients and gain new insights into the target cells and distribution of adalimumab and risankizumab

Conditions and MedDRA coding

Inflammatory Bowel Disease (IBD)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Established IBD diagnosis (UC or CD)
2. Active disease: clinically active disease of the bowel is defined as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin > 60 μg/g
3. Patients must be eligible for adalimumab or risankizumab therapy
4. Age of at least 18 years
5. Written informed consent
6. Clinical indication for an endoscopic procedure
7. For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs, or are less than 2 years postmenopausal: A negative pregnancy test (urine or blood test) must be available.

Exclusion criteria 6

1. A female study patient who is pregnant or provides breastfeeding
2. A female study patient of premenopausal age who does not use any reliable form of contraception at the time of adalimumab-680LT and/or risankizumab-800CW administration
3. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
4. Prior anti-IL23-specific therapy (IL12/IL23 combination therapy is not an exclusion criteria)
5. Prior anti-TNFα therapy in the last 6 weeks before inclusion
6. Previous treatment with adalimumab and detectable anti-adalimumab antibody levels

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Visual evaluation and distinction of both tracers during FME (visible signal yes/no), TBR and CNR calculations, mean fluorescence intensities (MFIs) of biopsies, MDSFR/SFF measurements and fluorescence/ light sheet microscopy

Secondary endpoints 4

1. Analysis of in vivo fluorescence images and quantification of fluorescence signal in real-time by spectroscopy. Semi-quantification of the fluorescence within mucosal biopsies (FFPE) with fluorescence scans and comparison with endoscopic/histologic inflammation score and in vivo results. Look at possible correlation of in vivo and ex vivo measured and quantified fluorescence and endoscopic/histologic response to adalimumab/risankizumab therapy
2. Quantification of fluorescent signals by dual wavelengths spectroscopy during the endoscopy. Measurements will be correlated with fluorescence intensities visualized using the FME camera and endoscopic/histologic inflammation severity to draw any conclusions about adalimumab/risankizumab distribution into inflamed or non-inflamed tissue. We hypothesize a positive correlation between the fluorescence signal and the tracer dose and between the fluorescence signal and the inflammation scores
3. 3D ex vivo fluorescence signal analysis on intact biopsies taken in high and low fluorescence areas during the endoscopy to assess the distribution of labeled adalimumab-680LT/risankizumab-800CW. We use SDS-PAGE with protein extract of the biopsies obtained during the endoscopy procedures and the patients' blood samples to prove tracer integrity. We will detect the protein and mRNA expression of TNF and IL23 via Western Blot to determine a correlation between tracer signal and target expression
4. We will perform fluorescence microcopy on FFPE slides of the biopsies to microscopically visualize the adalimumab-680LT/risankizumab-800CW signal and perform additional immunofluorescence staining (CD68, CD3, CD8, CD20, etc.) for different immune cell types to identify the immune cell type of adalimumab-680LT/risankizumab-800CW positive cells

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Wouter B. Nagengast

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Wouter B. Nagengast

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications