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Crohn DiseasePhase 1/2GUIDENCT06117423

Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

A Phase 1/2 study testing Adalimumab-680LT in people with Crohn Disease and Ulcerative Colitis, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease, Ulcerative Colitis
What is being tested?
Adalimumab-680LT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteNetherlands
Study dates
Mar 2024to Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Wouter B Nagengast, MD, PhD, PharmD contact

+31(0)503612620

w.b.nagengast@umcg.nl

Netherlands1 site, 1 recruiting

  • University Medical Center Groningen

    Groningen, 9713GZ

    Wouter B Nagengast, MD/PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: Investigating the Safety, Feasibility, and Optimal Dose of Fluorescently Labeled Adalimumab-680LT for Visualizing Drug Targeting in Inflammatory Bowel Diseases

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to the TNF receptors. Primary non-response to adalimumab is high in both CD and UC. Currently, there are no predictors of response to adalimumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of adalimumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled adalimumab (adalimumab-680LT). This study aims to assess the safety and the optimal dose of adalimumab-680LT to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).

Being tested
Adalimumab-680LT, Control
Keywords
Fluorescence Molecular Endoscopy, Inflammatory Bowel Disease, Adalimumab-680LT
Medical subject headings
Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalimumab-680LTDrug

    First, adalimumab-680LT was administered intravenously. 2-3 days later, a Fluorescence Molecular Imaging procedure was performed to enable the visualisation and detection of fluorescence signals.

  • ControlOther

    Fluorescence Molecular Imaging was performed to enable the visualisation and detection of fluorescence signals.

Study groups in NCT06117423
Study groupRoleWhat they receive
No administration of adalimumab-680LTOtherPatients did not receive adalimumab-680LT, but underwent a Fluorescence Molecular Imaging procedure to serve as a control group and compare results with patients receiving the tracer
Receives: Other: Control
4.5 mg adalimumab-680LTExperimentalPatients received 4.5 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure
Receives: Drug: Adalimumab-680LT
15 mg adalimumab-680LTExperimentalPatients received 15 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure
Receives: Drug: Adalimumab-680LT
25 mg adalimumab-680LTExperimentalPatients received 25 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure
Receives: Drug: Adalimumab-680LT
>14 weeks of adalimumab therapy + optimal dose adalimumab-680LTExperimentalPatients who received the optimal dose during the first Fluorescence Molecular Imaging procedure are invited for a second procedure after at least 14 weeks of adalimumab therapy. They will receive the optimal dose adalimumab-680LT and will undergo another Fluorescence Molecular Imaging procedure
Receives: Drug: Adalimumab-680LT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the safety of adalimumab-680LT in IBD

    Evaluating possible (severe) adverse events (SAE \& AEs)

    Measured: Until 24 hours after administration

  2. Blood pressure

    Millimeters of mercure (mmHg)

    Measured: Five minutes before, and five and sixty minutes after tracer administration

  3. Heart rate

    Beats per minute

    Measured: Five minutes before, and five and sixty minutes after tracer administration

  4. Temperature

    Degrees Celsius

    Measured: Five minutes before, and five and sixty minutes after tracer administration

  5. Investigate the feasibility of using FME to detect adalimumab-680LT signals

    Evaluating the performance of FME for detecting adalimumab-680LT signals. This evaluation will be based on a visual evaluation during FME (visible signal yes/no), TBR and CNR calculations and MDSFR/SFF measurements.

    Measured: 12 months

  6. Investigate the feasibility of using ex vivo FMI to detect adalimumab-680LT

    Evaluating the performance of ex vivo FMI for detecting adalimumab-680LT signals. This evaluation will be based on mean fluorescence intensities (MFIs) of biopsies and fluorescence/light sheet microscopy.

    Measured: 12 months

  7. Determining the optimal imaging dose of adalimumab-680LT

    The optimal dose will be based on the adalimumab-680LT signals during FME and ex vivo FMI

    Measured: 12 months

Secondary outcomes (5)

  1. Investigate a potential correlation of in vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of adalimumab therapy regimen in patients with IBD

    Evaluation of the potential correlation in vivo will be based on in vivo fluorescence images and the MDSFR/SFF measurements before and after at least 14 weeks of adalimumab treatment

    Measured: 12 months

  2. Investigate a potential correlation of ex vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of adalimumab therapy regimen in patients with IBD

    Evaluation of the potential correlation ex vivo will be based on MFIs of biopsies, fluorescence microscopy results, and tracer concentrations inside biopsies before and after at least 14 weeks of adalimumab treatment

    Measured: 12 months

  3. Quantify the fluorescence signals of the tracer in vivo by using single-fiber reflectance/single-fiber fluorescence (MDSFR/SFF) spectroscopy and correlate these measurements to tracer dose, in vivo fluorescence intensities and inflammation severity

    Quantification of MDSFR/SFF measurements in inflamed tissue compared to measurements in non-inflamed tissue. Positive correlation between MDSFR/SFF measurements and dose/inflammation severity?

    Measured: 12 months

  4. To correlate ex vivo fluorescence signals to inflammation severity and tracer dose based on histopathological examination inside the obtained biopsies

    Histologically ascertained tissue types (qualitative):

    Normal (non-inflamed) ileal, colon and rectal tissue Inflamed ileum, colon and rectum tissue Random ''high-fluorescent'' tissue Random ''Non-fluorescent'' tissue

    Measured: 12 months

  5. To assess tracer stability, tracer distribution and tracer concentration, and to identify the composition of immune cells ex vivo to learn more about adalimumab mucosal target cells

    Fluorescence (confocal) microscopy with additional use of immune panels and spatial transcriptomics analysis (before and after at least 14 weeks of adalimumab treatment). Measurements of the adalimumab-680LT concentration by light-sheet microscopy after tissue clearing, insights in adalimumab-target cells and presence of immune cells inside the biopsies and blood samples by flow cytometry and assessment of tracer stability by Western Blot

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study startMar 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06117423
Sponsor's protocol ID
18146
Other IDs
2023-508391-11-00, 2023
Acronym
GUIDE
Status last verified
Mar 2024
First submitted
23 Oct 2023
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adalimumab-680LT in people with Crohn Disease and Ulcerative Colitis, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wouter B Nagengast, MD, PhD, PharmD (+31(0)503612620, w.b.nagengast@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the safety of adalimumab-680LT in IBD (time frame: Until 24 hours after administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06117423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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