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    Summary
    EudraCT Number:2022-000652-11
    Sponsor's Protocol Code Number:SPAGOPIX-02
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-05-25
    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 ConcernedSweden - MPA
    A.2EudraCT number2022-000652-11
    A.3Full title of the trial
    A Phase IIa, single centre, open label, proof of concept study concerning efficacy of the novel intravenous contrast agent SN132D in patients with suspected endometriosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proof of concept study evaluating efficacy of the novel intravenous contrast agent SN132D in patients with suspected endometriosis
    A.4.1Sponsor's protocol code numberSPAGOPIX-02
    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 SponsorSpago Nanomedical AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSpago Nanomedical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpago Nanomedical AB
    B.5.2Functional name of contact pointpaul.hargreaves@spagonanomedical.se
    B.5.3 Address:
    B.5.3.1Street AddressScheelevägen 22
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-223 63
    B.5.3.4CountrySweden
    B.5.4Telephone number+46732 34 56 00
    B.5.6E-mailpaul.hargreaves@spagonanomedical.se
    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 nameSN132D
    D.3.2Product code SN132D
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpegfosimer manganese
    D.3.9.1CAS number 2641234-28-6
    D.3.9.3Other descriptive nameSN132D
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number65
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Suspected endometriosis
    E.1.1.1Medical condition in easily understood language
    Endometriosis
    Endometrios
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014778
    E.1.2Term Endometriosis
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the MRI enhancing properties of SN132D in participants with suspected endometriosis
    E.2.2Secondary objectives of the trial
    • To evaluate the diagnostic value of SN132D for detection of deep pelvic endometriosis lesions in participants with suspected endometriosis.
    • To evaluate the diagnostic value of SN132D for detection of endometriosis lesions in participants with suspected endometriosis.
    • To evaluate the safety of SN132D following single administration in participants with suspected endometriosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, participants must fulfil the following criteria:
    1. Signed informed consent including willingness to undertake 3 MRI investigations in one day
    2. Females with endometriosis or suspected endometrial lesions at ultrasound examination
    3. At least 18 years of age when signing the informed consent.
    4. Adequate renal and hepatic function: eGFR ≥ 50 mL/min/1.73 m2, bilirubin <1 x upper limit of normal (ULN), creatinine <1 x ULN, ASAT and ALAT < 1 x ULN.
    Bilirubin ULN: 25 µmol/L, creatinine ULN: 90 µmol/L, ASAT ULN: 0.60 µkat/L and ALAT ULN: 0.75 µkat/L) at the screening visit.
    5. Females of child-bearing potential* must agree to the use of effective contraception** or practice abstinence during the study and for 30 days after the IMP administration.
    6. Adequate haematological function: haemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.3x109 /L and platelet count ≥ 100 x 109 /L.
    *A female of child-bearing potential is a sexually mature female who 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. had had menses at any time in the preceding 24 consecutive months).
    **Effective contraception is defined as contraceptive methods with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]).
    E.4Principal exclusion criteria
    Participants must not enter the study if any of the following exclusion criteria are fulfilled:
    1. Female participants who are pregnant or who are currently breast feeding.
    2. Conditions contraindicating MRI including, but not limited to, BMI > 40 kg/m2 at screening claustrophobia, metallic implants or internal electrical devices (e.g., cochlear implant, nerve stimulator, gastric pacemaker, bladder stimulator, pacemaker, defibrillator, artificial valves in heart, aneurysm clips, etc.), and permanent makeup or tattoos which in the Investigator's opinion might jeopardise the patient's safety or interfere with the imaging measurements. The Investigator is encouraged to contact the MR clinic for advice on which implants, tattoos, etc may be unsuitable.
    3. Moderate to severe hypertension as judged by the Investigator.
    4. History of significant cardiovascular disease such as myocardial infarction, congestive heart failure, stroke, serious cardiac arrhythmias, history of angina within 6 months prior to screening.
    5. Clinically diagnosed obstruction of bile duct as judged by investigator.
    6. Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) which, in the opinion of the Investigator is clinically relevant, or will interfere with the ECG analysis.
    7. Abnormalities detected during examination at screening and admission, which in the opinion of the Investigator, may either put the patient at risk because of participation in the study or influence the results or the patient’s ability to participate in the study.
    8. Active infection requiring systemic treatment within one week prior to agent administration.
    9. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient’s ability to participate in the study.
    10. 6. Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. Participants with chronic HBV or HCV infection are eligible at the investigator’s discretion provided that the disease is stable and sufficiently controlled under treatment..
    11. Any use of alcohol within 24 hours of admission to the clinic.
    12. Plasma donation within 1 month of screening or any blood donation or corresponding blood loss during 3 months prior to screening.
    13. Use of investigational agent within four weeks before Visit 1 or plans to initiate treatment with an investigational agent during the study.
    E.5 End points
    E.5.1Primary end point(s)
    MRI enhancing effect:
    • Changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences:
    o Contrast-to-noise in endometriosis lesions vs reference tissue
    o Signal-to-noise in endometriosis lesions
    Additional MR-scan characteristic parameters may be calculated if deemed appropriate.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Predose MRI will be done same day as dose is given or up to 10 days before the dose. Second MRI is done 1 hour after the end of infusion and third MRI 4 hours after the end of infusion.
    E.5.2Secondary end point(s)
    Diagnostic Value Evaluation for deep pelvic endometriosis lesions and endometriosis lesions:
    • Compare the number, size and site of deep pelvic endometriosis lesions/endometriosis lesions obtained by SN132D imaging to TUS and clinically used non-contrast MRI.
    Safety:
    • Frequency and severity of adverse events (AEs)
    • Clinically significant changes in:
    Electrocardiogram (ECG)
    Vital signs
    Safety laboratory parameters
    Physical examination findings
    • Frequency and severity of injection site reactions
    E.5.2.1Timepoint(s) of evaluation of this end point
    Diagnostic value:
    Pre-dose MRI: same day as dose or up to 10 days before the dose. MRI post SN132D administration: 1h and 4h after the end of infusion. TUS is done same day as dose or up to 10 days before the dose.
    Safety:
    • Frequency and severity of AEs: Throughout the study, from dose until follow up.
    ECG and Vital signs: At screening and regular intervals from pre-dose until 4 h after end of infusion
    Safety laboratory parameters: At screening, pre-dose, 4 h after end of infusion and at follow-up visit (3-14 days after the dose)
    Physical examination findings: At screening, pre- dose, 4 h after end of infusion and at follow-up visit (3-14 days after the dose)
    • Frequency and severity of injection site reactions: Throughout the study, from dose until follow up
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 months6
    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: 18
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 state18
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-17
    P. End of Trial
    P.End of Trial StatusCompleted
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