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    Summary
    EudraCT Number:2012-001219-22
    Sponsor's Protocol Code Number:PGL11-021
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-09
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-001219-22
    A.3Full title of the trial
    A Phase IIa study investigating the efficacy and safety of the c-Jun-N-Terminal Kinase (JNK) inhibitor PGL5001 versus placebo administered for up to 5 months with concomitant administration of depot medroxyprogesterone acetate (DMPA) for the treatment of peritoneal and/or ovarian endometriosis with an inflammatory component, prior to surgery.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PGL5001 Proof of Concept study in inflammatory endometriosis
    A.3.2Name or abbreviated title of the trial where available
    JADE
    A.4.1Sponsor's protocol code numberPGL11-021
    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 SponsorPregLem S.A.
    B.1.3.4CountrySwitzerland
    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 supportPregLem SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPregLem SA
    B.5.2Functional name of contact pointGeneral Information desk
    B.5.3 Address:
    B.5.3.1Street Address3, Chemin du Pré-Fleuri
    B.5.3.2Town/ cityPlan-Les-Ouates, Geneva
    B.5.3.3Post code1228
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4122884 03 40
    B.5.5Fax number+4122 884 0349
    B.5.6E-mailinfo@preglem.com
    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 namePGL5001
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN bentamapimod
    D.3.9.2Current sponsor codePGL5001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.IMP: 2
    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 namePGL5001
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbentamapimod
    D.3.9.2Current sponsor codePGL5001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Peritoneal and/or ovarian endometriosis with an inflammatory component.
    E.1.1.1Medical condition in easily understood language
    Inflammatory endometriosis
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10014784
    E.1.2Term Endometriosis of ovary
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10014785
    E.1.2Term Endometriosis of pelvic peritoneum
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    There are no identified primary/main objective as compared to the other objectives in the study, hence the objectives are all listed in the secondary objectives below.
    E.2.2Secondary objectives of the trial
    EXPLORATORY EFFICACY OBJECTIVES:•To explore efficacy of PGL5001 with concomitant DMPA administration versus placebo with concomitant DMPA administration in: reducing endometriosis red lesions (and/or inflammatory lesions),reducing non-active endometriosis black lesions,reducing endometriosis associated-adhesions,improving endometriosis-related symptoms such as pain;•To evaluate the pharmacodynamics (PD) of PGL5001, establishing the relationship between JNK activity and endometriosis progression by assessing the level of different markers, especially inflammatory markers in the peritoneal fluid, blood and tissue samples (eutopic and ectopic endometrium).
    For PHARMACOKINETIC OBJECTIVES and SAFETY OBJECTIVES please refer to study protocol, section 2.2 and 2.3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
    1. The Subject must provide written informed consent prior to initiation of any study related procedures.
    2. The Subject must be an adult woman of reproductive age, aged from 18 and above.
    3. The Subject must have a BMI ≥ 18 kg/m2 and ≤ 40 kg/m2
    4. The Subject must be a newly diagnosed patient suffering from peritoneal and/or ovarian endometriosis with at least 15% of the endometriotic lesions observed at the study diagnostic laparoscopy being red inflammatory lesions and with a proven histological diagnosis.
    5. The Subject must consent to the scheduling of a second laparoscopy for surgical treatment at the study end.
    6. The Subject must have a history of pelvic pain for at least 3 months prior to the screening visit.
    7. The Subject must have a clinical breast examination without significant findings at the screening visit.
    8. The Subject must have no clinically significant findings at Papanikolaou test (PAP) smear, performed within the past 12 months or at the screening visit.
    9. The Subject must have access to a refrigerator where study drug can be properly stored.
    10. The Subject must be able and willing to comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
    1. The Subject is over 40 years old and has a FSH serum level during Day 2-4 of her cycle ≥ 21.5 mIU/ml.
    2. The Subject has a positive pregnancy test at baseline or is breast-feeding or planning a pregnancy during the course of the study.
    3. The Subject is known for having a cause of chronic abdominal/pelvic pain other than endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis).
    4. The Subject has a history of surgical treatment for endometriosis prior to the study diagnostic laparoscopy.
    5. The Subject has a history of or a current uterine, cervical, ovarian or breast cancer.
    6. The Subject has undiagnosed abnormal genital bleeding.
    7. The Subject has a history of or known current osteoporosis.
    8. The Subject is requiring urgent surgical excision of endometriotic lesions at the time of first diagnostic laparoscopy.
    9. The Subject has a chronic disease or conditions that could modify the absorption, distribution, metabolism, or excretion of the drug under investigation.
    10. The Subject has a history (in the past 12 months) of or a current medical treatment for endometriosis other than NSAID (e.g. GnRH agonist or antagonist, danazole, continuous oral combined oestroprogestogens).
    11. The Subject used oral contraceptives and/or progestins for contraception in the past 3 months before the first diagnostic laparoscopy.
    12. The Subject has current use of or is likely to require treatment with drugs that are not permitted during the study such as:
    a. Hormonal treatments
    b. GnRH-agonists/ antagonists
    c. Danazole
    d. Drugs metabolized through CYP2C8
    13. The Subject has abnormal hepatic function at study entry, defined as AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single re-test is allowed.
    14. The Subject has contraindications to the use of DMPA such as (please refer to the SmPC):
    a. active thrombophlebitis, current or history of thromboembolism or cerebrovascular disease
    b. confirmed or suspected hormone-dependent malignancy of the breast or the genital organs
    c. known sensitivity to medroxyprogesterone acetate or any ingredient of the vehicle (see list of ingredients in the SmPC).
    15. The Subject is unwilling to refrain from sun exposure during the treatment period and for 5 days post last dose.
    16. The Subject has abnormal baseline findings or any other medical condition(s), which in the opinion of the investigator, may jeopardise the subject’s safety or decrease the chance of obtaining reliable data.
    17. The Subject has a history of, or known current (within twelve months) problems with alcohol or drug abuse.
    18. The Subject has psychiatric disturbance or is otherwise unlikely to follow the study procedures.
    19. The Subject has participated in another clinical trial within the 30 days prior to the first screening visit.
    20. The Subject has an allergy to any of the ingredients of the PGL5001 capsule (see list of ingredients in the investigator’s brochure).
    E.5 End points
    E.5.1Primary end point(s)
    There are no identified primary endpoint in the study. All endpoints are listed in secondary endpoints below.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.5.2Secondary end point(s)
    EXPLORATORY EFFICACY ENDPOINTS
    • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the number and percentage of red lesions (and/or inflammatory lesions), based on total number of red and black lesions.
    • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the number and percentage of black lesions, based on total number of red and black lesions.
    • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the number of white lesions.
    • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the surface area (mm2) of red lesions.
    • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the surface area (mm2) of black lesions.
    • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the surface area (mm2) of white lesions.
    • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the presence of endometriosis-associated adhesions.
    • Mean score at end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) for the Surgeon’s Impression of Laparoscopic Change scale.
    • Mean score at end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) for the Clinical Global Impression of Improvement scale.
    • Percentage of patients at end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) with a confirmed improvement according to the scale for Surgeon’s Impression of Laparoscopic Change.
    • Percentage of patients at end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) with a confirmed improvement according to the scale for Clinical Global Impression of Improvement.
    • Change from baseline to Week 4 and Week 8 visits (for Parts A1, A2 and B), and to Week 12, Week 16 and Week 20 visits (for Part B only) in the non-menstrual pelvic pain mean score reported using a weekly Visual Analogue Scale (VAS) scoring.
    • Change from baseline to Week 4 and Week 8 visits (for Parts A1, A2 and B), and to Week 12, Week 16 and Week 20 visits (for Part B only) in the EHP-30 quality of life questionnaire.
    • Change from baseline to Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 visits (for Parts A1, A2 and B), and to Week 16, Week 20 and Week 24 visits (for Part B only) of selected proteins involved in JNK activity pathway and endometriosis physiopathology in blood samples.
    • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in selected proteins involved in JNK activity pathway and endometriosis physiopathology in peritoneal fluid and endometrial tissue samples (eutopic and ectopic).
    SAFETY ENDPOINTS
    • Number/percentage of subjects experiencing treatment emergent adverse events (TEAEs).
    • Number/percentage of subjects experiencing treatment emergent adverse events (TEAEs) leading to discontinuation of the study drug.
    • Laboratory safety test results (blood biochemistry, haematology, urinalysis), ECG, vital signs (blood pressure, pulse rate) and hormonal profile (including E2, P4, FSH, prolactin serum levels) at screening, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12 visits (for Parts A1, A2 and B), and at Week 16, Week 20 and Week 24 visits (for Part B only).
    PK ENDPOINTS
    • Pre-dose plasma levels of PGL5001 and DMPA at baseline and trough plasma levels of PGL5001 and DMPA at Week 1, Week 2, Week 4, Week 6 and Week 8 visits (for Parts A1, A2 and B) and at Week 12, Week 16 and Week 20 visits (for Part B only).
    • PGL5001 plasma levels at baseline (Week 0, Day 1) and Week 2 (Day 15) visits, 1 hour, 2 hours, 4 hours and 6 hours after the drug administration for Cmax determination
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Treatment visit (week 8 for study Part A-1 and A-2 and week 20 for study Part-B)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Part-A1 is open label,Part -A2 and Part B are double blind,see detailed study design in the protocol
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    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
    For administrative and safety reporting purposes the end of the study will be defined as the date of the final clinical database lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    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: 24
    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 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 state24
    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)
    Usual standard of care.
    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 Decision2012-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-06
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