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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-000478-25
    Sponsor's Protocol Code Number:MK-7962-008
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-10-07
    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 ConcernedGermany - PEI
    A.2EudraCT number2022-000478-25
    A.3Full title of the trial
    A Phase 2 Open-label Study to Evaluate the Safety, Tolerability,
    Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sotatercept in Children with Pulmonary Artery Hypertension on Standard of Care
    A.3.2Name or abbreviated title of the trial where available
    Sotatercept in Children with PAH on SoC
    A.4.1Sponsor's protocol code numberMK-7962-008
    A.5.4Other Identifiers
    Name:INDNumber:136150
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/227/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme LLC
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme LLC
    B.5.2Functional name of contact pointPaul Andrew Reyfman
    B.5.3 Address:
    B.5.3.1Street Address126 East Lincoln Avenue P.O. Box 2000
    B.5.3.2Town/ cityRahway, NJ
    B.5.3.3Post code07065
    B.5.3.4CountryUnited States
    B.5.6E-mailmsd42bamg@msd.de
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2369
    D.3 Description of the IMP
    D.3.1Product nameSotatercept
    D.3.2Product code MK-7962
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSotatercept
    D.3.9.1CAS number 1001080-50-7
    D.3.9.2Current sponsor codeMK-7962
    D.3.9.4EV Substance CodeSUB189200
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 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 Yes
    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
    Pulmonary arterial hypertension
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by high blood pressure (hypertension) in the arteries of the lungs
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10037403
    E.1.2Term Pulmonary hypertension NOS
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the safety and tolerability of sotatercept over 24 weeks of treatment
    2. To evaluate the PK of sotatercept over 24 weeks of treatment
    E.2.2Secondary objectives of the trial
    1. To evaluate the pharmacodynamics of sotatercept over 24 weeks of treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female participants ≥1 to <18 years of age at the time of providing documented informed consent/assent
    2. Documented, historic diagnostic RHC any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes (for participants with a history of cardiac intervention for shunt closure, the RHC confirmation must have been performed more than 6 months after the cardiac intervention):
    - IPAH
    - Heritable PAH
    - Drug/toxin-induced PAH
    - PAH associated with CTD
    - PAH-CHD with shunt closure >6 months before Screening and subsequently confirmed by RHC before Screening
    - PAH with coincidental shunt
    3. For the above-mentioned historical RHC, diagnostic criteria will be mean pulmonary artery pressure ≥20 mmHg at rest, pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤15 mmHg, and PVR indexed to body surface area, =3.0 WU.m2
    4. PAH classified as WHO FC I or symptomatic PAH classified as WHO FC II to IV
    5. Participants must be on a stable dose(s) of background PAH therapy:
    - WHO FC I to III: single, double, or triple background PAH therapy for at least 12 weeks before SCR and during SCR
    - WHO FC IV: must be clinically stable and on stable doses of maximum tolerated double or triple background PAH therapy for at least 30 days before SCR and during SCR
    6. Arterial BP at Screening within normal range for the age, gender, and height percentiles as follows:
    - Cohort 1: systolic BP <120 mmHg and diastolic BP <80 mmHg
    - Cohorts 2, 3, and 4: systolic and diastolic BP <90th percentile based on the corresponding age ranges as outlined in National High Blood Pressure Education Program, 2004
    7. Left ventricular ejection fraction ≥50% on the ECHO at Screening
    8. If male, agrees to the following during the intervention period and for at least 16 weeks after the last dose of study intervention:
    • Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent
    OR
    • Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview) as detailed below:
    - Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
    - Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    9. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    • Not a WOCBP
    OR
    • A WOCBP and:
    - Uses a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 16 weeks after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study intervention. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    - Has a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    - Abstains from breastfeeding during the study intervention period and for at least 16 weeks after study intervention
    - Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy
    10. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. The participant may also provide consent/assent for FBR. However, the participant may participate in the study without participating in FBR
    11. If male, agrees to refrain from donating blood or sperm for the duration of the study and for 16 weeks after the last dose of study intervention
    12. If female, agrees to refrain from donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks after the last dose of study intervention
    Optional Long-term Extension Treatment Period
    13. Completes Visit 9 of the Primary Treatment Period on study intervention
    14. The participant (or legally acceptable representative) has provided documented informed consent/assent for the Long-term Extension Treatment Period
    E.4Principal exclusion criteria
    1. History of left-sided heart disease, including valvular disease (eg, moderate or greater mitral or aortic regurgitation or stenosis), left ventricular outflow tract obstruction, and/or left heart failure (eg, restrictive or dilated cardiomyopathy)
    2. Severe (as based on the opinion of the investigator) congenital or developmental abnormalities of the lung, thorax, and/or diaphragm
    3. History of Eisenmenger syndrome, Potts shunt, atrial septostomy within 180 days prior to the screening visit, or atrial septostomy with Eisenmenger physiology
    4. Unrepaired or residual cardiac shunt with Qp/Qs >1.5
    5. Diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis, or overt signs of capillary and/or venous involvement
    6. PAH associated with portal hypertension
    7. Known visceral (lung, liver, or brain) arteriovenous malformation(s)
    8. History of full or partial pneumonectomy
    9. Untreated more than mild obstructive sleep apnea
    10. History of known pericardial constriction
    11. Family history of sudden cardiac death or long QT syndrome
    12. Any current or prior history of symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months before Screening
    13. Cerebrovascular accident within 3 months before Screening
    14. Prior exposure to sotatercept or luspatercept or has had an allergic reaction to any of their excipients
    15. Currently enrolled in or has completed a study with any other investigational products (small molecule drugs or biologics) within 30 days or 5 half-lives of that investigational product (whichever is longer) before Screening
    16. Screening platelet count <50,000/mm3
    17. Screening Hgb value above gender-specific ULN (per local laboratory)
    18. Screening eGFR <30 mL/min/m2 (as defined by the Bedside Schwartz equation) and/or a urine protein:creatinine ratio >1 g/g
    19. Screening AST and/or ALT >3X ULN
    20. Screening ECG with Fridericia’s corrected QT interval (QTcF) >500 ms (or >550 ms, if right bundle branch block is present)
    21. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study
    E.5 End points
    E.5.1Primary end point(s)
    1. Serum Trough Concentration (Ctrough) of Sotatercept
    2. Area Under the Curve at Steady State (AUCss) of Sotatercept
    3. Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept
    4. Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
    5. Percentage of Participants Who Discontinue Study Drug Due to an AE
    6. Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 21, 42, 63, 84, 105, and 126
    7. Laboratory Parameter (Hematology): Hematocrit on Days 21, 42, 63, 84, 105, and 126
    8. Laboratory Parameter (Hematology): RBC Count on Days 21, 42, 63, 84, 105, and 126
    9. Laboratory Parameter (Hematology): Reticulocyte Count on Days 21, 42, 63, 84, 105, and 126
    10. Laboratory Parameter (Hematology): Platelet Count on Days 21, 42, 63, 84, 105, and 126
    11. Blood Pressure (BP) at Days 21, 42, 63, 84, 105 and 126
    12. Titer of Anti-drug Antibody (ADA) to Sotatercept
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Predose Day 1, Day 7, Day 14, Predose Day 21, Day 22, Day 28, Day 35, Predose Days 42, 63, 84 and 105
    2. Predose Day 1, Day 7, Day 14, Predose Day 21, Day 22, Day 28, Day 35, Predose Days 42, 63, 84 and 105
    3. Predose Day 1, Day 7, Day 14, and Predose Day 21
    4. Up to 24 weeks
    5. Up to 24 weeks
    6. Up to 24 weeks
    7. Up to 24 weeks
    8. Up to 24 weeks
    9. Up to 24 weeks
    10. Up to 24 weeks
    11. Up to 24 weeks
    12. Up to 24 weeks
    E.5.2Secondary end point(s)
    1. Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2)
    2. Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)
    3. Mean Change from Baseline in Pulmonary Artery Systolic Pressure (PASP)
    4. Mean Change from Baseline in Right Ventricular Fractional Area Change (RVFAC)
    5. Mean Change from Baseline in Eccentricity Index
    6. Mean Change from Baseline in Right Ventricular (RV) Function (Cohort 1 and 2 Only)
    7. Mean Change from Baseline on Cardiac Output (Cohort 1 and 2 Only)
    8. Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohort 1 and 2 Only)
    9. Mean Change from Baseline in Pediatric Quality of Life (PedsQL) Generic Score
    10. Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP)
    11. Percentage of Participants who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline and Week 24
    2. Baseline and Week 24
    3. Baseline and Week 24
    4. Baseline and Week 24
    5. Baseline and Week 24
    6. Baseline and Week 24
    7. Baseline and Week 24
    8. Baseline and Week 24
    9. Baseline and Week 24
    10. Baseline and Week 24
    11. Baseline and Week 24
    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 No
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Colombia
    Australia
    France
    Germany
    Israel
    Mexico
    Netherlands
    Poland
    South Africa
    Spain
    Turkey
    United Kingdom
    United States
    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
    The overall study ends when the the last participant completes the last study-related contact, withdraws consent, or is lost to follow-up. For purposes of analysis and reporting, the overall study ends when the Sponsor receives the last laboratory test result or at the time of final contact with the last participant, whichever comes last
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    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: 42
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 42
    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)
    Age above 18 will transfer to open label SOTERIA study
    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 Decision2022-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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