Heart Failure Clinical Trial
A Study of Ponsegromab in People With Heart Failure
Summary
The purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (A pill that looks like the study medicine but does not contain the active medicine) to find out if the study medicine is better than the placebo (a pill that looks like the study medicine but does not contain the active medicine) for treatment of symptoms related to heart failure. Participants will not know which treatment group they are assigned to. All participants in this study will receive the study medicine or placebo by shots under the skin every four weeks. People may be able to participate in this study if they have the heart failure. Participants will take part in this study for about 9 months. During this time participants will visit the study clinic once a month.
Full Description
The primary purpose of this study is to assess the effect of repeated subcutaneous administration of ponsegromab (PF-06946860) compared to placebo on frequency, severity, and burden of symptoms as well as physical limitations in participants with heart failure and elevated circulating GDF-15 concentrations. The study will also assess the safety, tolerability, PK, PD, and immunogenicity of ponsegromab.
A separate, open-label, PK cohort, with more frequent PK and GDF-15 collection after single and multiple subcutaneous administration of ponsegromab (PF-06946860), will be enrolled at certain sites in the United States and Canada to facilitate a more comprehensive assessment of PK characteristics and PK/PD relationship for GDF-15 in participants with heart failure.
Eligibility Criteria
Inclusion Criteria:
Male and female participants aged 18 years or older
-. Clinical evidence of HF with each of the following criteria:
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).
NYHA class II-IV at screening.
Main cohort only: NT-proBNP ≥400 pg/mL at screening.
Serum GDF-15 concentration ≥2000 pg/mL at screening.
Main cohort only: KCCQ-23 CSS <75 at screening.
Main cohort only: Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following at screening:
Non-edematous unintentional weight loss ≥5% in the last 6 months or current BMI <20 kg/m2, associated with subjective fatigue or anorexia; or
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
A score of <60 on the Physical Limitations Domain of the KCCQ 23 administered at screening.
Exclusion Criteria:
Acute decompensated HF within 1 month prior to Screening Visit 1 or during the screening period.
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.
History of heart transplantation, currently listed for heart transplant, current/planned mechanical circulatory support, or current/planned use of intravenous inotropes (eg, dobutamine, milrinone).
Acute coronary syndrome within 1 month prior to randomization.
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.
Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm abnormality (ie, tachyarrhythmia or bradyarrhythmia).
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of study intervention used in this study. Treatment with an investigational biologic agent within 6 months or 5 half-lives (whichever is longer) of Day 1.
Previous exposure to ponsegromab in a prior clinical study.
Renal disease requiring ongoing dialysis.
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).
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There are 123 Locations for this study
Fairhope Alabama, 36532, United States
Los Angeles California, 90033, United States
Washington District of Columbia, 20010, United States
Fort Lauderdale Florida, 33308, United States
Fort Lauderdale Florida, 33308, United States
Fort Lauderdale Florida, 33308, United States
Atlanta Georgia, 30303, United States
Hazel Crest Illinois, 60429, United States
Richmond Indiana, 47374, United States
Boston Massachusetts, 02115, United States
Detroit Michigan, 48202, United States
Traverse City Michigan, 49684, United States
Minneapolis Minnesota, 55455, United States
Minneapolis Minnesota, 55455, United States
Minneapolis Minnesota, 55455, United States
Minneapolis Minnesota, 55455, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63108, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Teaneck New Jersey, 07666, United States
Chapel Hill North Carolina, 27514, United States
Chapel Hill North Carolina, 27599, United States
Oklahoma City Oklahoma, 73135, United States
Dallas Texas, 75231, United States
Concord New South Wales, 2139, Australia
Brisbane Queensland, 4064, Australia
Chermside Queensland, 4032, Australia
Southport Queensland, 4215, Australia
Elizabeth Vale South Australia, 5112, Australia
Melbourne Victoria, 3004, Australia
New Westminster British Columbia, V3L 3, Canada
Halifax Nova Scotia, B3H 3, Canada
Cambridge Ontario, N1R 7, Canada
London Ontario, N6A 5, Canada
North York Ontario, M6B 3, Canada
Oshawa Ontario, L1J 2, Canada
Peterborough Ontario, K9J 0, Canada
Toronto Ontario, M1B 5, Canada
Toronto Ontario, M5B 1, Canada
Winchester Ontario, K0C 2, Canada
Montreal Quebec, H1T 1, Canada
Montréal Quebec, H2X 3, Canada
Rimouski Quebec, G5L 5, Canada
Saint-Jean-sur-Richelieu Quebec, J3A 1, Canada
Terrebonne Quebec, J6V 2, Canada
Trois-Rivieres Quebec, G9A 4, Canada
Beijing Beijing, 10003, China
Guangzhou Guangdong, 51000, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51008, China
Changsha Hunan, 41001, China
Changsha Hunan, 41001, China
Hengyang Hunan, 42100, China
Changchun Jilin, 13003, China
Xi'an Shaanxi, 71006, China
Jinan Shandong, 25001, China
Shanghai Shanghai, 20003, China
Yuncheng Shanxi, 04400, China
Tianjin Tianjin, 30012, China
Tianjin Tianjin, 30012, China
Beijing , 10003, China
Brno Jihomoravský KRAJ, 602 0, Czechia
Jaroměř Náchod, 551 0, Czechia
Prague Praha 4, 140 2, Czechia
Praha 10 , 100 3, Czechia
Praha 2 , 12808, Czechia
Praha 6 , 16902, Czechia
Göttingen Niedersachsen, 37075, Germany
Bad Oeynhausen Nordrhein-westfalen, 32545, Germany
Dresden Sachsen, 01277, Germany
Jena Thuringia, 7743, Germany
Jena Thüringen, 07747, Germany
Pécs Baranya, 7624, Hungary
Kecskemét Bács-kiskun, 6000, Hungary
Békéscsaba Békés, 5600, Hungary
Mosonmagyaróvár Győr-moson-sopron, 9200, Hungary
Nyiregyhaza Nyíregyháza, 4400, Hungary
Kaposvár Somogy, 7400, Hungary
Budapest , 1023, Hungary
Budapest , 1097, Hungary
Budapest , 1122, Hungary
Nagykanizsa , 8800, Hungary
Amagasaki Hyogo, 660-8, Japan
Himeji Hyogo, 670-8, Japan
Takarazuka Hyogo, 665-0, Japan
Morioka Iwate, 020-0, Japan
Sendai Miyagi, 983-8, Japan
Kishiwada Osaka, 596-0, Japan
Osaka-shi Osaka, 530-0, Japan
Suita Osaka, 564-8, Japan
Suita Osaka, 564-8, Japan
Sumiyoshi Ward Osaka, 558-8, Japan
Wako Saitama, 351-0, Japan
Shinjuku-ku Tokyo, 160-8, Japan
Kumamoto , 861-4, Japan
Osaka , 558-8, Japan
Wrocław Dolnośląskie, 50-55, Poland
Warszawa Mazowieckie, 04-62, Poland
Gdynia Pomorskie, 81-47, Poland
Olsztyn Warmińsko-mazurskie, 10-04, Poland
Poznan Wielkopolskie, 61-84, Poland
Lodz , 92-21, Poland
Tychy , 43-10, Poland
Warsaw , 02-09, Poland
Warszawa , 02-09, Poland
Katowice Śląskie, 40-55, Poland
A Coruña A Coruña [LA Coruña], 15006, Spain
Santiago de Compostela A Coruña [LA Coruña], 15706, Spain
Barcelona Barcelona [barcelona], 08003, Spain
Barcelona Barcelona [barcelona], 08035, Spain
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Barcelona Catalunya [cataluña], 08041, Spain
Madrid Madrid, Comunidad DE, 28034, Spain
Majadahonda Madrid, Comunidad DE, 28222, Spain
El Palmar, Murcia Murcia, Región DE, 30120, Spain
Valencia Valenciana, Comunitat, 46010, Spain
Granada , 18012, Spain
Madrid , 28046, Spain
Málaga , 29010, Spain
Oviedo , 33011, Spain
Sevilla , 41013, Spain
Valencia , 46014, Spain
Valencia , 46026, Spain
High Wycombe Buckinghamshire, HP11 , United Kingdom
Dundee Dundee CITY, DD1 9, United Kingdom
London England AND Wales, SW17 , United Kingdom
Harrow London, CITY OF, HA1 3, United Kingdom
Glasgow Scotland, G31 2, United Kingdom
Barnet , EN5 3, United Kingdom
Cambridge , CB2 0, United Kingdom
Clydebank , G81 4, United Kingdom
Lincoln , LN2 5, United Kingdom
Liverpool , L9 7A, United Kingdom
Sheffield , S5 7A, United Kingdom
Stockton-On-Tees , TS19 , United Kingdom
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