Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

Sponsor
University Medical Center Groningen
Study ID
NCT06117423
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab-680LT — DRUG
    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.
  • Control — OTHER
    Fluorescence Molecular Imaging was performed to enable the visualisation and detection of fluorescence signals.

Study Details

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).

Key Dates

Start date
Mar 31, 2024
Status verified
Mar 2024
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Other: No administration of adalimumab-680LT
    Patients 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
  • Experimental: 4.5 mg adalimumab-680LT
    Patients received 4.5 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure
  • Experimental: 15 mg adalimumab-680LT
    Patients received 15 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure
  • Experimental: 25 mg adalimumab-680LT
    Patients received 25 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure
  • Experimental: >14 weeks of adalimumab therapy + optimal dose adalimumab-680LT
    Patients 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

Primary Outcome Measure

Determine the safety of adalimumab-680LT in IBD [ Time Frame: Until 24 hours after administration ]

Central Contacts

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