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    Summary
    EudraCT Number:2022-003857-78
    Sponsor's Protocol Code Number:D-CN-52014-244
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2023-06-29
    Trial results View 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2022-003857-78
    A.3Full title of the trial
    A phase III, open-label, multicentre, single arm study to assess the efficacy and safety of the triptorelin 6-month formulation in Chinese paediatric participants with central precocious puberty
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study seeks to check if a drug named as triptorelin 6-month
    formulation is safe and works to treat a condition called central
    precocious puberty in Chinese children. Precocious puberty is a condition
    that causes early sexual development in girls and boys. This trial was
    conducted at multiple-centers and was open-label which means subjects
    knew what medicine they were getting.
    A.4.1Sponsor's protocol code numberD-CN-52014-244
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05029622
    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 SponsorIpsen Pharma
    B.1.3.4CountryFrance
    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 supportIpsen Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address65, Quai Georges Gorse
    B.5.3.2Town/ cityBoulogne Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 58 33 50 50
    B.5.6E-mailclinical.trials@ipsen.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 Yes
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nametriptorelin pamoate
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIPTORELIN PAMOATE
    D.3.9.1CAS number 124508-66-3
    D.3.9.4EV Substance CodeSUB16393MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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
    Central Precocious Puberty
    E.1.1.1Medical condition in easily understood language
    To assess efficacy of triptorelin 6-month PR formulation in suppressing LH levels to prepubertal levels (defined as peak LH ≤5 IU/L) after i.v. GnRH stimulation at Month 6 in Chinese children with CPP
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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
    The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).
    E.2.2Secondary objectives of the trial
    - To assess the efficacy in suppressed LH response to GnRH test at Months 3 and 12
    - To assess change of basal serum LH and follicle-stimulating hormone (FSH) levels at Months 3, 6, 9 and 12
    - To assess change of peak serum LH and FSH levels after the GnRH stimulation test at Months 3, 6 and 12
    - To assess sex hormone serum concentrations (oestradiol for girls and testosterone for boys) at Months 3, 6, 9 and 12
    - To assess height (Z-score [height for age] and percentile for height for age) growth velocity and BA (Greulich and Pyle method) at Months 6 and 12
    - To assess sexual maturation at Months 6 and 12
    - To assess uterine length in girls and testis volumes in boys at Months 6 and 12
    - To assess the change of body weight and BMI at Months 6 and 12
    - To assess the safety profile
    - To evaluate local tolerability at the injection site immediately and 2 hours after triptorelin injection
    - To assess the PK of plasma triptorelin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant is less than 9 years old for girls and less than 10 years old for boys at initiation of triptorelin treatment or at the time of signing the informed consent.
    - Participant must present evidence of CPP documented by:
    - Onset of development of secondary sex characteristics (breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II) before the age of 8 years in girls and 9 years in boys.
    - Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥6 IU/L) in both sexes.
    - Difference between bone age (BA) and CA >1 year.
    - Girls with Tanner staging ≥2 for breast development and who have enlarged uterine length and/or ovarian volume and at last 2 follicles with diameter >4 mm in the ovary observed by pelvic type B ultrasound at the Screening visit; boys who have testicular volume ≥4 mL observed by testicular orchidometer at the Screening visit.
    - Girls who have already had menophania/menarche must have a negative highly sensitive (urine) pregnancy test as required by local regulations within 24 hours before the first dose of study intervention and should not be at risk of pregnancy throughout the study period.
    E.4Principal exclusion criteria
    - Gonadotropin-independent (peripheral) precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion.
    - Non-progressing isolated premature thelarche.
    - Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
    - Prior or current therapy with a GnRHa (Gonadotropin-releasing Hormone Agonist) , medroxyprogesterone acetate, growth hormone or insulin-like growth factor 1 (IGF 1).Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of children with LH (Luteinising Hormone) suppression defined as stimulated peak LH ≤5 IU/L after GnRH (Gonadotropin-releasing Hormone) stimulation
    E.5.1.1Timepoint(s) of evaluation of this end point
    At month 6
    E.5.2Secondary end point(s)
    1. Proportion of children with LH response to GnRH test
    2. Change from basal serum LH levels
    3. Change from baseline in basal serum FSH (Follicle-stimulating Hormone) levels
    4. Change from baseline in peak serum LH levels after the GnRH stimulation test
    5. Change from baseline in peak serum FSH levels after the GnRH stimulation test
    6. Proportion of children with pre-pubertal levels of sex steroids
    7. Change from baseline in height-for-age Z-score
    8. Change from baseline in height-for-age percentile
    9. Change from baseline in growth velocity
    10. Proportion of children in whom the BA/CA (Bone Age/Chronological Age) ratio did not rise (X ray).
    11. Change from baseline in the ratio BA/CA
    12. Proportion of children who achieve stabilisation of sexual maturation using Tanner method
    13. Proportion of girls with regression of uterine length
    14. Proportion of boys with absence of progression of testis volumes
    15. Change from baseline in BMI (Body Mass Index)
    16. Change from baseline in weight
    17. Incidence of TEAEs (treatment-emergent adverse events), including local tolerability at the injection site
    18. Change from baseline in clinical safety laboratory: blood biochemistry parameters. (Creatinine, Non fasting Glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase, Total and direct bilirubin, Calcium, Phosphorous)
    19. Change from baseline in clinical safety laboratory haematology parameters (Complete blood count).
    20. Change from baseline in clinical safety laboratory urinalysis parameters (Specific gravity, pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick)
    21. Change from baseline in physical examination
    22. Change from baseline in vital signs: Change in heart rate
    23. Change from baseline in vital signs: Change in blood pressure
    24. Sparse plasma triptorelin concentrations
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At months 3 and month 12
    2. At months 3, 6, 9 and 12
    3. At months 3,6, 9 and 12
    4. At months 3, 6 and 12
    5. At months 3, 6 and 12
    6. Months 3, 6, 9 and 12
    7. At months 6 and 12
    8. At months 6 and 12
    9. At months 6 and 12
    10. At months 6 and 12
    11. At months 6 and 12
    12. At months 6 and 12
    13. At months 6 and 12
    14. At month 6 and 12
    15. At months 6 and 12
    16. At months 6 and 12
    17. Throughout the study
    18. At month 3, 6, 9 and 12
    19. At month 3, 6, 9 and 12
    20. At month 3, 6, 9 and 12
    21. At months 3, 6, 9 and 12
    22. At months 3, 6, 9 and 12
    23. At months 3, 6, 9 and 12
    24. At day 1, months 3, 6 and 12
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    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.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 66
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 66
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Investigator, will obtain written informed consent from each participant’s legal guardian
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 66
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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