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Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis. (VIDEO)

Primary Purpose

Psoriasis, Crohn Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ustekinumab
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Established diagnosis of CD or PsO Active disease: CD cohort: clinically active disease of the bowel defined either clinically as at least moderate activity using dedicated scoring indices (for definitions of disease activity, see below) or biochemically active disease as defined by a faecal calprotectin > 200 ug/g; PsO: clinically active disease of at least PASI ≥ 10 or clinically active disease as assessed by a dermatologist; Ustekinumab naïve and eligible for ustekinumab treatment (except for patients in the treatment arm); Age ≥ 18 years; Written informed consent. Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician; Concurrent uncontrolled medical conditions according to treating medical physician; Prior ustekinumab treatment (except for patients in the treatment arm); Ustekinumab contraindicated as therapy; Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause); Received a different investigational drug within 30 days prior to the dose of ustekinumab-800CW according to the patient's medical history; History of infusion reactions to ustekinumab or other monoclonal antibodies according to the patient's medical history; Received any live (including attenuated) vaccination within the 8 weeks prior to the inclusion. Live vaccines are not allowed during the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Ustekinumab naïve patients

    Ustekinumab treatment 12+ weeks

    Arm Description

    Outcomes

    Primary Outcome Measures

    Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2023
    Last Updated
    May 8, 2023
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05725876
    Brief Title
    Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.
    Acronym
    VIDEO
    Official Title
    Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis: a Prospective Pilot Intervention Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Crohn's Disease (CD) and psoriasis are chronic inflammatory diseases. Ustekinumab is a humanized monoclonal antibody. Ustekinumab is expensive and primary non-response is high in both CD and psoriasis. Currently, there are no predictors of response to ustekinumab and the actual mechanism of action has not yet been elucidated. To clarify the mechanism of action and gain a better understanding of the high primary non-response rates, the University Medical Center Groningen (UMCG) developed a tracer fluorescently labeling ustekinumab. This study aims to gain insight into ustekinumab distribution and concentrations in the gut. The current study aims to identify the ustekinumab target cells in the inflamed gut mucosa and skin using quantitative fluorescence molecular endoscopy (qFME). By gaining insight into local ustekinumab concentrations, drug distribution, and by discovering target cells, we expect to gain insight into the mechanism of action of ustekinumab.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis, Crohn Disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Model Description
    15 naive patients before treatment and 10 control patients during treatment in both diseases. So 2 arms in each disease.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ustekinumab naïve patients
    Arm Type
    Experimental
    Arm Title
    Ustekinumab treatment 12+ weeks
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Ustekinumab
    Intervention Description
    Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.
    Primary Outcome Measure Information:
    Title
    Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients.
    Time Frame
    3-4 days after tracer admission

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Established diagnosis of CD or PsO Active disease: CD cohort: clinically active disease of the bowel defined either clinically as at least moderate activity using dedicated scoring indices (for definitions of disease activity, see below) or biochemically active disease as defined by a faecal calprotectin > 200 ug/g; PsO: clinically active disease of at least PASI ≥ 10 or clinically active disease as assessed by a dermatologist; Ustekinumab naïve and eligible for ustekinumab treatment (except for patients in the treatment arm); Age ≥ 18 years; Written informed consent. Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician; Concurrent uncontrolled medical conditions according to treating medical physician; Prior ustekinumab treatment (except for patients in the treatment arm); Ustekinumab contraindicated as therapy; Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause); Received a different investigational drug within 30 days prior to the dose of ustekinumab-800CW according to the patient's medical history; History of infusion reactions to ustekinumab or other monoclonal antibodies according to the patient's medical history; Received any live (including attenuated) vaccination within the 8 weeks prior to the inclusion. Live vaccines are not allowed during the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    W.B. Nagengast, MD, PhD, PharmD
    Phone
    +31503612620
    Email
    w.b.nagengast@umcg.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    A.J. Sterkenburg, MSc
    Phone
    +316 55257029
    Email
    a.j.sterkenburg@umcg.nl

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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