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    Summary
    EudraCT Number:2022-002822-28
    Sponsor's Protocol Code Number:11034
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-002822-28
    A.3Full title of the trial
    CD8 T cell imaging by positron emission tomography with 89Zr-Df-IAB22M2C in giant cell arteritis and rheumatoid arthritis: a pilot study
    CD8 T-cel beeldvorming door positron emissie tomografie met 89Zr-Df-IAB22M2C in reuscelarteriitis en reumatoïde artritis: een pilot studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging of inflamed arteries in giant cell arteritis and inflamed joints in rheumatoid arthritis with a PET/CT scan.
    Beeldvorming van ontstoken bloedvaten in reuscelarteriitis en ontstoken gewrichten in reumatoïde artritis met een PET/CT scan
    A.4.1Sponsor's protocol code number11034
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Center Groningen, Department of Rheumatology and Clinical Immunology
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointCo-ordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressUMCG (HPC AA21), Hanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503619185
    B.5.5Fax number0031503619308
    B.5.6E-mailk.s.m.van.der.geest@umcg.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name89Zr-Df-Crefmirlimab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZirconium-89
    D.3.9.3Other descriptive nameZirconium-89
    D.3.9.4EV Substance CodeSUB130861
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number14.8 to 22.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcrefmirlimab
    D.3.9.1CAS number 2611099-93-3
    D.3.9.3Other descriptive nameMinibody against CD8
    D.3.9.4EV Substance CodeSUB218014
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    giant cell arteritis and rheumatoid arthritis
    reuscelarteriitis en reumatoïde artritis
    E.1.1.1Medical condition in easily understood language
    giant cell arteritis and rheumatoid arthritis
    reuscelarteriitis en reumatoïde artritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective: to evaluate arterial and synovial 89Zr-Df-crefmirlimab uptake on PET/CT in patients with newly-diagnosed GCA or active RA.
    Primaire doel: evalueren van arteriële en synoviale 89Zr-Df-crefmirlimab opname op PET/CT in patiënten met nieuwe RCA of actieve RA.
    E.2.2Secondary objectives of the trial
    1. Assessment of the relationship between 89Zr-Df-crefmirlimab uptake and the presence of CD8 T cells in histological analysis of the temporal artery biopsy in patients with newly-diagnosed, cranial GCA
    2. Assessment of the relationship between 89Zr-Df-crefmirlimab uptake and clinical joint assessment and histological analysis of synovial tissue in patients with RA.
    1. Bepalen van relatie tussen 89Zr-Df-crefmirlimab opname en aanwezigheid van CD8 T cellen in histologische analyse van arteria temporalis biopten van patiënten met nieuwe, craniële RCA
    2. Bepalen van relatie tussen 89Zr-Df-crefmirlimab opname en bevindingen bij klinische gewrichtsonderzoek en histologische analyse van synoviale weefsels van patiënten met RA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Giant cell arteritis
    - Age > 50 years
    - Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L
    - Clinical symptoms of GCA present at time of inclusion:
    • Large vessel GCA (at least one of the following): constitutional symptoms (fatigue, fever, weight loss, and/or night sweats), limb claudication, or symptoms of polymyalgia rheumatica (i.e. shoulder and/or hip girdle pain associated with morning stiffness)
    • Cranial GCA (at least one of the following): new-onset localized headache, scalp tenderness, temporal artery abnormality (thickening, tenderness, and/or decreased pulsation), ischemia-related vision loss, stroke, transient ischemic attack, jaw or tongue claudication (pain upon mastication).
    - Imaging findings or temporal artery biopsy findings consistent with GCA at the time of inclusion
    • Large vessel GCA as suggested by ultrasonography or FDG-PET/CT
    • Cranial GCA as suggested by ultrasonography FDG-PET/CT or temporal artery biopsy and confirmed by temporal artery biopsy
    - Patients must be able to adhere to the study appointments and other protocol requirements.
    - Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.

    Rheumatoid arthritis
    - Patients must be at least 30 years of age
    - Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria.
    - Patients with clinically active disease as assessed by a physician; with arthritis in at least one wrist, knee or ankle joint and have a clinical indication to initiate or escalate treatment
    - Treatment with disease modifying anti-rheumatic drugs (DMARDS) and oral corticosteroid up to 10 mg daily is allowed, provided that there is a stable dose for at least 4 weeks prior to inclusion
    - Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion
    - Patients must be able to adhere to the study appointments and other protocol requirements
    - Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.
    Reuscelarteriitis:
    - Leeftijd > 50 jaar
    - BSE 50 mm/uur of meer; of CRP 10 mg/L of meer
    - Aanwezigheid van klinische symptomen van RCA
    - Beeldvorming of arteria temporalis biopt positief voor RCA
    - In staat tot nakomen van studieafspraken en andere protocolverplichtingen
    - In staat tot geven informed consent; consent moet verkregen worden vóór start studiegerelateerde procedures

    Reumatoïde artritis
    - Leeftijd >30jaar
    - Voldoen aan 2010 ACR/EULAR classificatiecriteria voor RA
    - Actieve ziekte volgens arts; met artritis minimaal in 1 pols, knie of enkel; met klinische noodzaak tot starten dan wel ophogen van behandeling
    - Behandeling met DMARDs of orale corticosteroiïden (max 10 mg prednisolon equivalent dag)
    - NSAID gebruik is toegestaan mits stabiele dosering gedurende 4 weken voor inclusie
    - In staat tot nakomen van studieafspraken en andere protocolverplichtingen
    - In staat tot geven informed consent; consent moet verkregen worden vóór start studiegerelateerde procedures
    E.4Principal exclusion criteria
    Giant cell arteritis
    - Age ≤ 50 years
    - Use of oral, intravenous or intramuscular glucocorticoids within 4 weeks prior to inclusion.
    - Use of disease-modifying antirheumatic drugs (DMARD) within 3 months prior to inclusion.
    - Treatment with any investigational drug within 3 months prior to inclusion.
    - Known pregnancy or breast feeding
    - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion.
    - Urinary or faecal incontinence

    Rheumatoid arthritis
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - Age < 30 years
    - Use of intra-articular, intramuscular or intravenous corticosteroids within 4 weeks prior to inclusie
    - Treatment with any investigational drug within the previous 3 months
    - Known pregnancy or breast feeding
    - Research related radiation exposure (cumulative ≥5 mSv) in the year before inclusion
    - Urinary or faecal incontinence
    Reuscelarteriitis:
    - Leeftijd 50 jaar of minder
    - Gebruik van orale, intraveneuze of intramusculaire glucocorticoiden in periode 4 weken voor inclusie
    - Gebruiken DMARD in 3 maanden voor inclusie
    - Behandeling met investigational drug in 3 maanden voor inclusie
    - Actuele zwangerschap of geven van borstvoeding
    - Onderzoeksgerelateerde blootstelling aan straling (cumulatief 5 mSv of meer) in jaar voor inclusie
    - Incontintentie voor urine of feces

    Reumatoide artritis
    - Leeftijd < 30 jaar
    - Gebruik intra-articulaire, intramusculaire of intraveneuze corticosteroiden in 4 weken voor inclusie
    - Behandeling met investigational drug in 3 maanden voor inclusie
    - Actuele zwangerschap of geven van borstvoeding
    - Onderzoeksgerelateerde blootstelling aan straling (cumulatief 5 mSv of meer) in jaar voor inclusie
    - Incontinentie voor urine of feces
    E.5 End points
    E.5.1Primary end point(s)
    The primary 89Zr-Df-crefmirlimab PET/CT measurements are the tracer uptake in different arteries or joints whereby the radioactivity concentration in Regions-of-Interest (ROIs) are expressed as SUVs (Standardized Uptake Values).
    Primaire 89Zr-Df-crefmirlimab PET/CT metingen zijn tracer opname in verschillende arteriën of gewrichten waarbij radioactiviteit concentratie in 'regions of interest' (ROIs) worden uitgedrukt als SUVs (standardized uptake values).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years
    3 jaar
    E.5.2Secondary end point(s)
    1. The relationship between 89Zr-Df-crefmirlimab uptake and the presence of CD8 T cells in histological analysis of the temporal artery biopsy in patients with newly-diagnosed, cranial GCA
    2. Assessment of the relationship between 89Zr-Df-crefmirlimab uptake and clinical joint assessment and histological analysis of synovial tissue in patients with RA.
    1. Relatie tussen 89Zr-Df-crefmirlimab opname en aanwezigheid van CD8 T cellen in histologische analyse van arteria temporalis biopten van patiënten met nieuwe, craniële RCA
    2. Relatie tussen 89Zr-Df-crefmirlimab opname en bevindingen van klinische gewrichtsbeoordeling en histologische analyse van synoviaal weefsel in patiënten met RA
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    3 jaar
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    laatste visite van laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-01
    P. End of Trial
    P.End of Trial StatusOngoing
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