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    Summary
    EudraCT Number:2022-001809-50
    Sponsor's Protocol Code Number:C3651011
    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:2022-10-21
    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 number2022-001809-50
    A.3Full title of the trial
    A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 4-ARM
    STUDY TO INVESTIGATE SYMPTOMS, FUNCTION, HEALTH-RELATED
    QUALITY OF LIFE AND SAFETY WITH REPEATED SUBCUTANEOUS
    ADMINISTRATION OF PONSEGROMAB VERSUS PLACEBO IN ADULT
    PARTICIPANTS WITH HEART FAILURE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of the Effects of Ponsegromab on Health-Related Quality
    of Life and Safety in Patients With Heart Failure (GARDEN-TIMI 74)
    A.4.1Sponsor's protocol code numberC3651011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05492500
    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 SponsorPfizer Inc.
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address66 Hudson Boulevard East
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10001
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePonsegromab
    D.3.2Product code PF-06946860
    D.3.4Pharmaceutical form 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 INNPonsegromab
    D.3.9.2Current sponsor codePF-06946860
    D.3.9.4EV Substance CodeSUB219317
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heart failure
    E.1.1.1Medical condition in easily understood language
    A clinical syndrome in which impaired myocardial contractile function leads to dyspnea or exertional limitations that impair a patient’s ability to perform activities of daily life.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10019280
    E.1.2Term Heart failures
    E.1.2System Organ Class 10007541 - Cardiac 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 compare the effect of ponsegromab versus placebo, on HF disease-specific health status in participants with HF.
    E.2.2Secondary objectives of the trial
    Main Cohort:
    - To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF.
    - To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF.
    - To compare the effect of ponsegromab versus placebo on the
    physical function of participants with HF.
    - To compare the effect of ponsegromab versus placebo on fatigue reported by participants with HF.
    - To describe the safety and tolerability of ponsegromab in participants with HF.
    Open-Label PK Cohort:
    -To evaluate the safety and tolerability of ponsegromab in participants with HF and elevated circulating GDF-15 concentrations.
    Open-label, PK Cohort: At certain sites in the US and Canada, where permitted, participants who fail to qualify for the main cohort may be eligible for participation in a separate open-label, PK cohort.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age and Sex:
    1. Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.
    a. A female participant is eligible to participate if she is not pregnant or breastfeeding.
    b. To refer to Appendix 4 of Protocol for reproductive criteria for male (Section 10.4.1 of Protocol) and female (Section 10.4.2 of Protocol) participants.
    Disease Characteristics:
    2. Clinical evidence of HF with each of the following criteria:
    a. LVEF <50% on most recent measurement, within 12 months of screening.
    Note: An assessment of LVEF in the prior 12 months is not required in
    situations where LVEF has been persistently <50% on prior assessments
    obtained at least 3 months apart (including the most recent
    measurement).
    b. NYHA class II-IV at screening.
    c. Main cohort only:NT-proBNP ≥400 pg/mL at screening.
    3. Serum GDF-15 concentration ≥2000 pg/mL at screening.
    4. Main cohort only: KCCQ-23 CSS <75 at screening.
    5. Main cohort only: Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following at screening:
    a. Non-edematous unintentional weight loss ≥5% in the last 6 months or current BMI <20 kg/m2, associated with subjective fatigue or anorexia; or
    b. Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks based on the KCCQ-23 administered at screening; or
    c. A score of <60 on the Physical Limitations Domain of the KCCQ-23
    administered at screening.
    6. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures (including but not limited to subcutaneous injection of study intervention).
    E.4Principal exclusion criteria
    Medical Conditions:
    1. Acute decompensated HF within 1 month prior to SV1 or during the screening period.
    2. Implantation of a cardiac resynchronization therapy device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial.
    * For the open-label, PK cohort only: implantation of a cardiac resynchronization therapy device more than 1 month prior to randomization is permitted.
    3. History of heart transplantation, currently listed for heart transplant, current/planned mechanical circulatory support, or current/planned use of intravenous inotropes (eg, dobutamine, milrinone).
    4. Acute coronary syndrome within 1 month prior to randomization.
    5. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 3 months prior to randomization or intent to undergo coronary revascularization during the trial.
    • For the open-label, PK cohort only: coronary revascularization more than 1 month prior to randomization is permitted.
    6. Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm abnormality (i.e, tachyarrhythmia or bradyarrhythmia).
    7. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody.
    8. Other medical (eg, severe, uncorrected aortic stenosis; active malignancy) or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, may limit life expectancy to less than 1 year and / or make the participant inappropriate for the study.
    9. Current use of any prohibited concomitant medication(s). To refer to Section 6.9 of Protocol.
    10. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Treatment with an investigational biotherapeutic agent within 6 months or 5 half-lives (whichever is longer) of Day 1.
    11. Previous exposure to ponsegromab in a prior clinical study.
    12. Renal disease requiring ongoing dialysis.
    13. Cirrhosis with evidence of portal hypertension not due to HF or the following LFT abnormalities at the time of screening, confirmed by a repeat test if deemed necessary: AST or ALT Level = 3 x ULN, or total bilirubin level = 2 x ULN (unless history of Gilbert's syndrome).
    14. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    15.Open-label, PK Cohort: At certain sites in the US and Canada, where permitted, participants who fail to qualify for the main cohort may be eligible for participation in a separate open-label, PK cohort.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in KCCQ-23 CSS at Week 22.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 22
    E.5.2Secondary end point(s)
    For objective "To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF": Change from baseline in KCCQ-23 OSS, TSS, and physical limitation at Week 22.
    For objective "To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF": Responses as defined by a ≥5-point increase from baseline in
    KCCQ-23 CSS, OSS, TSS, and physical limitation at Week 22.
    For objective "To compare the effect of ponsegromab versus placebo on the physical function of participants with HF": Change from baseline in 6MWD at Week 22.
    For objective "To compare the effect of ponsegromab versus placebo on fatigue reported by participants with HF": Change from baseline in PROMIS Fatigue 7a at Week 22.
    For objective "To describe the safety and tolerability of ponsegromab in participants with HF": Incidence of TEAEs, TESAEs, abnormal laboratory results, and vital signs.
    For PK Open-Label PK Cohort secondary
    Objective "Incidence of TEAEs, TESAEs, abnormal laboratory results, and vital signs."
    Open-label, PK Cohort: At certain sites in the US and Canada, where permitted, participants who fail to qualify for the main cohort may be eligible for participation in a separate open-label, PK cohort.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 22 for all Main Cohort secondary endpoint except for the last one (To describe the safety and tolerability of ponsegromab in participants with HF) which will be evaluated throughout the trial as applicable. For Open-Label PK Cohort: throughout the trial.
    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 Yes
    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 Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Australia
    Canada
    China
    Czechia
    Germany
    Hungary
    Japan
    Poland
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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 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: 218
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 218
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 436
    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)
    No study intervention will be provided to participants at the end of their study participation. It is expected that participants will be treated as required with standard-of-care treatments, as advised by their usual care physician.
    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 Decision2023-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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