Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease (GUIDE)

University Medical Center Groningen (UMCG)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Ulcerative Colitis; Crohn Disease

Treatments: Drug: Adalimumab-680LT; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06117423

2023-508391-11-00 (Other Identifier)

18146

Details and patient eligibility

About

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).

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 5 patient groups

No administration of adalimumab-680LT

Other group

Description:

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

Treatment:

Other: Control

4.5 mg adalimumab-680LT

Experimental group

Description:

Patients received 4.5 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure

Treatment:

Drug: Adalimumab-680LT

15 mg adalimumab-680LT

Experimental group

Description:

Patients received 15 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure

Treatment:

Drug: Adalimumab-680LT

25 mg adalimumab-680LT

Experimental group

Description:

Patients received 25 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure

Treatment:

Drug: Adalimumab-680LT

>14 weeks of adalimumab therapy + optimal dose adalimumab-680LT

Experimental group

Description:

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

Treatment:

Drug: Adalimumab-680LT