Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

NCT ID: NCT06117423

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-06-30

Brief 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. 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).

Conditions

Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Control

Intervention Type: OTHER

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

4.5 mg adalimumab-680LT

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

Group Type: EXPERIMENTAL

Adalimumab-680LT

Intervention Type: 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.

15 mg adalimumab-680LT

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

Group Type: EXPERIMENTAL

Adalimumab-680LT

Intervention Type: 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.

25 mg adalimumab-680LT

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

Group Type: EXPERIMENTAL

Adalimumab-680LT

Intervention Type: 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.

>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

Group Type: EXPERIMENTAL

Adalimumab-680LT

Intervention Type: 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.

Interventions

Adalimumab-680LT

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.

Intervention Type: DRUG

Control

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

dr. W.B. Nagengast, MD

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Wouter B Nagengast, MD, PhD, PharmD

Role: CONTACT

w.b.nagengast@umcg.nl

+31(0)503612620

Facility Contacts

Wouter B Nagengast, MD/PhD

Role: primary

Other Identifiers

2023-508391-11-00

Identifier Type: OTHER

Identifier Source: secondary_id

18146

Identifier Type: -

Identifier Source: org_study_id