Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509747-27-00 | Registry Identifier | CTIS (EU) |
Not provided
Not provided
Following a prespecified interim analysis, and in consultation with the independent Data Monitoring Committee, the Sponsor terminated the study
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The TIMI Study Group | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (an injection 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 (an injection 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. Most 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 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.
A separate PK cohort within this clinical trial will receive open-label study medicine (Ponsegromab/PF-06946860) only. Participants in this open-label, PK cohort will not receive placebo. These participants will receive the study medicine by shots under the skin every four weeks. People may be able to participate in this study cohort if they also have heart failure. Participants will take part in the open-label, PK cohort for about 7 months.
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 different ranges of 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 to facilitate a more comprehensive assessment of PK characteristics and PK/PD relationship for GDF-15 in participants with heart failure and elevated circulating GDF-15 concentrations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main cohort (Cohort A): ponsegromab low dose | Experimental | Participants will receive a low dose Q4W SC |
|
| Main cohort (Cohort A): ponsegromab medium dose | Experimental | Participants will receive a medium dose Q4W SC |
|
| Main cohort (Cohort A): ponsegromab high dose | Experimental | Participants will receive a high dose Q4W SC |
|
| Main cohort (Cohort A): placebo | Placebo Comparator | matched placebo |
|
| Open-label, PK Cohort (Cohort B): ponsegromab low dose | Experimental | Participants will receive a low dose Q4W SC |
|
| Open-label, PK Cohort (Cohort B): ponsegromab medium dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Main cohort (Cohort A): Ponsegromab low dose | Drug | Ponsegromab low dose subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 - Clinical Summary Score (CSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed health related quality of life (HRQL) in participants with heart failure (HF) over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ total symptom score (TSS): mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status. | Baseline [the last measurement on study Day 1], Week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in KCCQ-23 CSS at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status. |
Not provided
Inclusion Criteria:
Male and female participants aged 18 years or older
-. Clinical evidence of HF with each of the following criteria:
Serum GDF-15 concentration ≥2000 pg/mL at screening.
Cohort D only: Serum GDF-15 concentration <2000 pg/mL at screening.
KCCQ-23 CSS <75 at screening (Note: Does not apply to open-label, PK Cohort [Cohort B]).
Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following at screening (Note: Does not apply to open-label, PK Cohort [Cohort B]):
Exclusion Criteria:
For the open-label, PK cohort (Cohort B) only: implantation of a cardiac resynchronization therapy device more than 1 month prior to randomization is permitted.
For the open-label, PK cohort (Cohort B) only: coronary revascularization more than 1 month prior to randomization is permitted.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern shore Research Institute LLC | Fairhope | Alabama | 36532 | United States | ||
| Keck Medical Center of USC |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
The following cohorts were planned for the study: Cohort A, Cohort B, Cohort C and Cohort D. No participants were enrolled either in Cohort C or Cohort D due to study termination and data for these cohorts is not reported in any section of the record.
A total of 455 participants were enrolled, randomized and treated in this study: 433 participants in cohort A and 22 participants in cohort B.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Placebo | Participants in Cohort A were randomized to receive placebo matched to ponsegromab subcutaneously (SC), once in every 4 weeks (Q4W) from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| FG001 | Cohort A: Ponsegromab 100mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cohort A: Double-Blind Treatment |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2024 | Feb 25, 2026 |
Not provided
In the main cohort (Cohort A), ponsegromab will be administered at low, medium and high doses every 4 weeks by subcutaneous injections for a total of 6 doses. Participants will be randomized to 1 of the 3 doses of ponsegromab or placebo.
In optional Cohort C, ponsegromab will be administered at low doses every 4 weeks by subcutaneous injections for a total of 6 doses. Participants will be randomized to the low dose of ponsegromab or placebo.
In optional Cohort D, ponsegromab will be administered at high doses every 4 weeks by subcutaneous injections for a total of 6 doses. Participants will be randomized to the high dose of ponsegromab or placebo.
In a separate open-label, PK cohort (Cohort B), ponsegromab will be administered at low, medium and high doses every 4 weeks by subcutaneous injections for a total of 4 doses. Participants will be randomized to 1 of the 3 doses of ponsegromab. There is no placebo in the open-label, PK cohort.
Not provided
Not provided
In the main cohort (Cohort A), Cohort C and Cohort D, investigators, sponsor, participants and other site staff will be blinded to participants' assigned study intervention, including the site staff assigned to prepare and administer the study intervention. Pharmacists and site personnel will be blinded to study intervention versus placebo within each study arm.
The separate PK cohort (Cohort B) will be open-label and study treatment will be prepared and administered as per treatment assignment by qualified personnel. There is no blinding in the open-label, PK cohort (Cohort B).
| Experimental |
Participants will receive a medium dose Q4W SC |
|
| Open-label, PK Cohort (Cohort B): ponsegromab high dose | Experimental | Participants will receive a high dose Q4W SC |
|
| Optional Cohort C: ponsegromab low dose | Experimental | Participants will receive a low dose Q4W SC |
|
| Optional Cohort C: placebo | Placebo Comparator | matched placebo |
|
| Optional Cohort D: ponsegromab high dose | Experimental | Participants will receive a high dose Q4W SC |
|
| Optional Cohort D: placebo | Placebo Comparator | matched placebo |
|
| Main cohort (Cohort A): Ponsegromab medium dose | Drug | Ponsegromab medium dose subcutaneous injection |
|
|
| Main cohort (Cohort A): ponsegromab high dose | Drug | Ponsegromab high dose subcutaneous injection |
|
|
| Main cohort (Cohort A): Matched placebo | Other | Matched placebo subcutaneous injection |
|
|
| Open-label, PK Cohort (Cohort B): ponsegromab low dose | Drug | ponsegromab low dose subcutaneous injection |
|
|
| Open-label, PK Cohort (Cohort B): ponsegromab medium dose | Drug | Ponsegromab medium dose subcutaneous injection |
|
|
| Open-label, PK Cohort (Cohort B): ponsegromab high dose | Drug | Ponsegromab high dose subcutaneous injection |
|
|
| Optional Cohort C: Ponsegromab low dose | Drug | Ponsegromab low dose subcutaneous injection |
|
|
| Optional Cohort C: Matched placebo | Other | Matched placebo subcutaneous injection |
|
|
| Optional Cohort D: Ponsegromab high dose | Drug | Ponsegromab high dose subcutaneous injection |
|
|
| Optional Cohort D: Matched placebo | Other | Matched placebo subcutaneous injection |
|
|
| Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in KCCQ-23-Overall Summary Score (OSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status. | Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in KCCQ-23 OSS at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status. | Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in KCCQ-23-TSS at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status. | Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in KCCQ-23 TSS at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status. | Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in KCCQ-23 Physical Limitation Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status. | Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in KCCQ-23 Physical Limitation Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status. | Baseline [the last measurement on study Day 1], Week 22 |
| Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23-CSS at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status. | Week 22 |
| Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 CSS Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status. | Week 22 |
| Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 OSS Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status. | Week 22 |
| Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 OSS Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status. | Week 22 |
| Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 TSS Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status. | Week 22 |
| Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 TSS Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status. | Week 22 |
| Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 PL Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status. | Week 22 |
| Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 PL Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status. | Week 22 |
| Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | The 6-minute walk test (6MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWD (distance travelled in meters) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. | Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in 6MWD at Week 22: Cohort A | The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWD (distance travelled in meters) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. | Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue (Version 7a) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | The PROMIS Fatigue 7a is a self-reported measure that assessed a range of symptoms in the past 7 days from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The short form (SF) 7A consisted of 7 items that study participants rated from 1: "Never" to 5: "Always". A global raw score ranged from 7 to 35 was calculated and translated into a T-score with minimum of 29.4 and maximum of 83.2 (mean = 50, a standard deviation [SD] = 10) using the applicable score conversion provided in the PROMIS user's manual. Higher scores indicated more fatigue. | Baseline [the last measurement on study Day 1], Week 22 |
| Change From Baseline in PROMIS Fatigue (Version 7a) at Week 22: Cohort A | The PROMIS Fatigue 7a is a self-reported measure that assessed a range of symptoms in the past 7 days from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The short form (SF) 7A consisted of 7 items that study participants rated from 1: "Never" to 5: "Always". A global raw score ranged from 7 to 35 was calculated and translated into a T-score (mean = 50, a standard deviation [SD] = 10) using the applicable score conversion provided in the PROMIS user's manual. Higher scores indicated more fatigue. | Baseline [the last measurement on study Day 1], Week 22 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs): Cohort A | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. TESAE was a TEAE which met the definition of serious adverse event (SAE) viz. any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was considered an important medical event. AEs included SAEs and all other AEs (non-SAEs). | From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks) |
| Number of Participants With Any Abnormalities in Laboratory Test Parameters: Cohort A | Laboratory parameters included were: hematology (hemoglobin, hematocrit, red blood cells [RBC] count, platelet count, white blood cells [WBC] count) and chemistry (urea and creatinine, estimated glomerular filtration rate [eGFR], cystatin C [at baseline only], sodium, potassium, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase [ALP], total protein, glucose [non-fasting] and lipid panel, total cholesterol, high-density lipoprotein [HDL] cholesterol, Non HDL cholesterol, calculated low-density lipoprotein [LDL] cholesterol and triglycerides. Number of participants with any abnormalities in laboratory test parameters as judged by investigator were reported. | From first dose of study treatment (Day 1) up to Week 22 |
| Number of Participants With Abnormalities in Vital Signs: Cohort A | Vital signs abnormalities criteria included: supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg), increase and decrease in change of >= 30mmHg; supine diastolic blood pressure (DBP) <50 mmHg, increase and decrease in change of >=20mmHg; and pulse rate (PR) <40 beats per minute (bpm) and >120 bpm. | From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks) |
| Number of Participants With TEAEs and TEASAEs: Cohort B | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. TESAE was a TEAE which met the definition of SAE viz. any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was considered an important medical event. AEs included SAEs and all other AEs (non-SAEs). | From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks) |
| Number of Participants With Any Abnormalities in Laboratory Test Parameters: Cohort B | Laboratory parameters included were: hematology (hemoglobin, hematocrit, RBC count, platelet count, WBC count) and chemistry (urea and creatinine, eGFR, cystatin C [at baseline only], sodium, potassium, AST, ALT, total bilirubin, ALP, total protein, glucose [non-fasting] and lipid panel, total cholesterol, HDL cholesterol, Non HDL cholesterol, calculated LDL cholesterol and triglycerides. Number of participants with any abnormalities in laboratory test parameters as judged by investigator were reported. | From first dose of study treatment (Day 1) maximum up to 4 weeks post Week 12 (maximum up to approximately 16 weeks) |
| Number of Participants With Abnormalities in Vital Signs: Cohort B | Vital signs criteria included: supine SBP <90 mmHg, increase and decrease in change of >= 30mmHg; supine DBP <50 mmHg, increase and decrease in change of >=20mmHg; and PR <40 bpm to >120 bpm. | From start of study drug on Day 1 maximum up to 4weeks post last dose on Week 12 (maximum up to approximately Week 16) |
| Los Angeles |
| California |
| 90033 |
| United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University School of Medicine-Grady Campus | Atlanta | Georgia | 30303 | United States |
| Chicago Medical Research | Hazel Crest | Illinois | 60429 | United States |
| Reid Physician Associates | Richmond | Indiana | 47374 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Traverse Heart & Vascular | Traverse City | Michigan | 49684 | United States |
| M Health Fairview Clinics and Surgery Center | Minneapolis | Minnesota | 55455 | United States |
| M Health Fairview University of Minnesota Investigational Drug Services | Minneapolis | Minnesota | 55455 | United States |
| M Health Fairview University of Minnesota Medical Center-East Bank | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota/Lillehei Clinical Research Unit | Minneapolis | Minnesota | 55455 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University in St. Louis Center for Outpatient Health (COH) | St Louis | Missouri | 63108 | United States |
| Washington University in St. Louis Center for Advanced Medicine (CAM) | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27514 | United States |
| Clinical and Translational Research Center | Chapel Hill | North Carolina | 27599 | United States |
| South Oklahoma Heart Research, LLC | Oklahoma City | Oklahoma | 73135 | United States |
| Texas Health Heart & Vascular Specialist (THHVS) #18760 | Dallas | Texas | 75231 | United States |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Core Research Group | Brisbane | Queensland | 4064 | Australia |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Lyell McEwin Hospital | Elizabeth Vale | South Australia | 5112 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Fraser Clinical Trials Inc | New Westminster | British Columbia | V3L 3W4 | Canada |
| QEII Health Sciences Centre - Victoria General Site | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Saul Vizel Professional Medicine Corporation dba Vizel Cardiac Research | Cambridge | Ontario | N1R 7R1 | Canada |
| University Hospital - London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| North York Diagnostic and Cardiac Centre | North York | Ontario | M6B 3H7 | Canada |
| Private Practice - Dr. James Cha | Oshawa | Ontario | L1J 2K1 | Canada |
| Kawartha Cardiology Clinical Trials | Peterborough | Ontario | K9J 0B2 | Canada |
| Corcare | Toronto | Ontario | M1B 5N1 | Canada |
| Unity Health Toronto, St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Community Care Building | Winchester | Ontario | K0C 2K0 | Canada |
| Winchester District Memorial Hospital | Winchester | Ontario | K0C 2K0 | Canada |
| Institut de Cardiologie de Montreal | Montreal | Quebec | H1T 1C8 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 3E4 | Canada |
| Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski | Rimouski | Quebec | G5L 5T1 | Canada |
| CardioVasc HR Inc | Saint-Jean-sur-Richelieu | Quebec | J3A 1J2 | Canada |
| Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur. | Terrebonne | Quebec | J6V 2H2 | Canada |
| Diex Recherche Trois-Rivieres | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | 421001 | China |
| China-Japan Union Hospital | Changchun | Jilin | 130033 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250014 | China |
| Zhongshan Hospital,Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Yuncheng Central Hospital | Yuncheng | Shanxi | 044000 | China |
| Tianjin People' s Hospital | Tianjin | Tianjin Municipality | 300120 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| EDUMED - Jaroměř | Jaroměř | Náchod | 551 01 | Czechia |
| Institut Klinicke a Experimentalni Mediciny | Prague | Praha 4 | 140 21 | Czechia |
| Fakultni Nemocnice u sv. Anny v Brne | Brno | South Moravian | 602 00 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 12808 | Czechia |
| Ustredni vojenska nemocnice | Prague | 16902 | Czechia |
| Universitätsklinikum Frankfurt Goethe-Universität | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitätsmedizin Göttingen - Georg-August-Universität | Göttingen | Lower Saxony | 37075 | Germany |
| Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien | Dresden | Saxony | 01277 | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | 7743 | Germany |
| Pécsi Tudományegyetem Klinikai Központ | Pécs | Baranya | 7624 | Hungary |
| Private Practice - Dr. Lakatos Ferenc | Békéscsaba | Bekes County | 5600 | Hungary |
| TaNa Med | Mosonmagyaróvár | Győr-Moson-Sopron | 9200 | Hungary |
| Medifarma 98 Kft | Nyíregyháza | Nyíregyháza | 4400 | Hungary |
| Somogy Vármegyei Kaposi Mór Oktató Kórház | Kaposvár | Somogy County | 7400 | Hungary |
| Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet | Budapest | 1097 | Hungary |
| Semmelweis Egyetem | Budapest | 1122 | Hungary |
| Kanizsai Dorottya Korhaz | Nagykanizsa | 8800 | Hungary |
| Hyogo Prefectural Amagasaki General Medical Center | Amagasaki | Hyōgo | 660-8550 | Japan |
| Hyogo Prefectural Harima-Himeji General Medical Center | Himeji | Hyōgo | 670-8560 | Japan |
| Higashi Takarazuka Satoh Hospital | Takarazuka | Hyōgo | 665-0873 | Japan |
| Iwate Prefectural Central Hospital | Morioka | Iwate | 020-0066 | Japan |
| National Hospital Organization Sendai Medical Center | Sendai | Miyagi | 983-8520 | Japan |
| Kishiwada Tokushukai Hospital | Kishiwada | Osaka | 596-0042 | Japan |
| National Cerebral and Cardiovascular Center | Suita | Osaka | 564-8565 | Japan |
| National Hospital Organization Saitama Hospital | Wako | Saitama | 351-0102 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Osaka General Medical Center | Osaka | 558-8558 | Japan |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Greater Poland Voivodeship | 61-848 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu | Wroclaw | Lower Silesian Voivodeship | 50-556 | Poland |
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Kardio Brynow | Katowice | Silesian Voivodeship | 40-555 | Poland |
| Miejski Szpital Zespolony w Olsztynie | Olsztyn | Warmian-Masurian Voivodeship | 10-045 | Poland |
| SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi | Lodz | 92-213 | Poland |
| Polsko Amerykanskie Kliniki Serca | Tychy | 43-100 | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny | Warsaw | 02-097 | Poland |
| CHUAC-Complejo Hospitalario Universitario A Coruña | A Coruña | A Coruña [LA Coruña] | 15006 | Spain |
| CHUS - Hospital Clinico Universitario | Santiago de Compostela | A Coruña [LA Coruña] | 15706 | Spain |
| Parc de Salut Mar - Hospital del Mar | Barcelona | Barcelona [barcelona] | 08003 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [barcelona] | 08035 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalunya [cataluña] | 08041 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid, Comunidad de | 28222 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | El Palmar | Murcia, Región de | 30120 | Spain |
| Hospital Clinico de Valencia | Valencia | Valenciana, Comunitat | 46010 | Spain |
| Hospital Universitario Virgen Nieves | Granada | 18012 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Wycombe General Hospital | High Wycombe | Buckinghamshire | HP11 2TT | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | Dundee CITY | DD1 9SY | United Kingdom |
| St. George's Hospital | London | England and Wales | SW17 0QT | United Kingdom |
| Northwick Park Hospital | Harrow | London, CITY of | HA1 3UJ | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | Scotland | G31 2ER | United Kingdom |
| Barnet Hospital | Barnet | EN5 3DJ | United Kingdom |
| Royal Papworth Hospital NHS Foundation Trust | Cambridge | CB2 0AY | United Kingdom |
| Golden Jubilee National Hospital | Clydebank | G81 4DY | United Kingdom |
| Lincoln County Hospital | Lincoln | LN2 5QY | United Kingdom |
| Liverpool University Hospitals NHS Foundation Trust | Liverpool | L9 7AL | United Kingdom |
| Northern General Hospital | Sheffield | S5 7AU | United Kingdom |
| University Hospital of North Tees | Stockton-on-Tees | TS19 8PE | United Kingdom |
Participants in Cohort A were randomized to receive ponsegromab 100 milligrams (mg), Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| FG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| FG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| FG004 | Cohort B: Ponsegromab 100mg | Participants in Cohort B were randomized to receive ponsegromab 100 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. |
| FG005 | Cohort B: Ponsegromab 200mg | Participants in Cohort B were randomized to receive ponsegromab 200 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. |
| FG006 | Cohort B: Ponsegromab 300mg | Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Cohort B: Open Label Treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Placebo | Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| BG001 | Cohort A: Ponsegromab 100mg | Participants in Cohort A were randomized to receive ponsegromab 100 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| BG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| BG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| BG004 | Cohort B: Ponsegromab 100mg | Participants in Cohort B were randomized to receive ponsegromab 100 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. |
| BG005 | Cohort B: Ponsegromab 200mg | Participants in Cohort B were randomized to receive ponsegromab 200 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. |
| BG006 | Cohort B: Ponsegromab 300mg | Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 - Clinical Summary Score (CSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed health related quality of life (HRQL) in participants with heart failure (HF) over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ total symptom score (TSS): mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status. | Censored analysis set: randomized participants who took >=1 dose of study drug. Participants who discontinued study drug or got a prohibited procedure; or missed dose, or got an incomplete dose, all observations post-discontinuation/procedure; post-missed/incomplete dose respectively, were censored. Participants who resumed dosing, their subsequent data usage in analysis was post review of their compliance prior to database lock. "Overall Number of Participants Analyzed": evaluable participants. | Posted | Least Squares Mean | 90% Confidence Interval | Units on a Scale | Baseline [the last measurement on study Day 1], Week 22 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in KCCQ-23 CSS at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in KCCQ-23-Overall Summary Score (OSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | Units on a Scale | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in KCCQ-23 OSS at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in KCCQ-23-TSS at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | Units on a Scale | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in KCCQ-23 TSS at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in KCCQ-23 Physical Limitation Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | Units on a Scale | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in KCCQ-23 Physical Limitation Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23-CSS at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Multiple imputation was used for missing data. | Posted | Number | Percentage of Participants | Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 CSS Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. No imputation technique was applied. | Posted | Number | Percentage of Participants | Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 OSS Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Multiple imputation was used for missing data. | Posted | Number | Percentage of Participants | Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 OSS Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. No imputation technique was applied. | Posted | Number | Percentage of Participants | Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 TSS Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Multiple imputation was used for missing data. | Posted | Number | Percentage of Participants | Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 TSS Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. No imputation technique was applied. | Posted | Number | Percentage of Participants | Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 PL Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Multiple imputation was used for missing data. | Posted | Number | Percentage of Participants | Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 PL Score at Week 22: Cohort A | KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. No imputation technique was applied. | Posted | Number | Percentage of Participants | Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | The 6-minute walk test (6MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWD (distance travelled in meters) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | Meters | Baseline [the last measurement on study Day 1], Week 22 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 6MWD at Week 22: Cohort A | The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWD (distance travelled in meters) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Meters | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue (Version 7a) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo | The PROMIS Fatigue 7a is a self-reported measure that assessed a range of symptoms in the past 7 days from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The short form (SF) 7A consisted of 7 items that study participants rated from 1: "Never" to 5: "Always". A global raw score ranged from 7 to 35 was calculated and translated into a T-score with minimum of 29.4 and maximum of 83.2 (mean = 50, a standard deviation [SD] = 10) using the applicable score conversion provided in the PROMIS user's manual. Higher scores indicated more fatigue. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | T-score | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in PROMIS Fatigue (Version 7a) at Week 22: Cohort A | The PROMIS Fatigue 7a is a self-reported measure that assessed a range of symptoms in the past 7 days from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The short form (SF) 7A consisted of 7 items that study participants rated from 1: "Never" to 5: "Always". A global raw score ranged from 7 to 35 was calculated and translated into a T-score (mean = 50, a standard deviation [SD] = 10) using the applicable score conversion provided in the PROMIS user's manual. Higher scores indicated more fatigue. | Censored analysis set was used. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | T-score | Baseline [the last measurement on study Day 1], Week 22 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs): Cohort A | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. TESAE was a TEAE which met the definition of serious adverse event (SAE) viz. any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was considered an important medical event. AEs included SAEs and all other AEs (non-SAEs). | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Abnormalities in Laboratory Test Parameters: Cohort A | Laboratory parameters included were: hematology (hemoglobin, hematocrit, red blood cells [RBC] count, platelet count, white blood cells [WBC] count) and chemistry (urea and creatinine, estimated glomerular filtration rate [eGFR], cystatin C [at baseline only], sodium, potassium, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase [ALP], total protein, glucose [non-fasting] and lipid panel, total cholesterol, high-density lipoprotein [HDL] cholesterol, Non HDL cholesterol, calculated low-density lipoprotein [LDL] cholesterol and triglycerides. Number of participants with any abnormalities in laboratory test parameters as judged by investigator were reported. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to Week 22 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Vital Signs: Cohort A | Vital signs abnormalities criteria included: supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg), increase and decrease in change of >= 30mmHg; supine diastolic blood pressure (DBP) <50 mmHg, increase and decrease in change of >=20mmHg; and pulse rate (PR) <40 beats per minute (bpm) and >120 bpm. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs and TEASAEs: Cohort B | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. TESAE was a TEAE which met the definition of SAE viz. any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was considered an important medical event. AEs included SAEs and all other AEs (non-SAEs). | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Abnormalities in Laboratory Test Parameters: Cohort B | Laboratory parameters included were: hematology (hemoglobin, hematocrit, RBC count, platelet count, WBC count) and chemistry (urea and creatinine, eGFR, cystatin C [at baseline only], sodium, potassium, AST, ALT, total bilirubin, ALP, total protein, glucose [non-fasting] and lipid panel, total cholesterol, HDL cholesterol, Non HDL cholesterol, calculated LDL cholesterol and triglycerides. Number of participants with any abnormalities in laboratory test parameters as judged by investigator were reported. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) maximum up to 4 weeks post Week 12 (maximum up to approximately 16 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Vital Signs: Cohort B | Vital signs criteria included: supine SBP <90 mmHg, increase and decrease in change of >= 30mmHg; supine DBP <50 mmHg, increase and decrease in change of >=20mmHg; and PR <40 bpm to >120 bpm. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study drug on Day 1 maximum up to 4weeks post last dose on Week 12 (maximum up to approximately Week 16) |
|
Cohort A: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks); Cohort B: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: Placebo | Participants in Cohort A were randomized to receive placebo matched to ponsegromab SC, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. | 17 | 198 | 55 | 198 | 94 | 198 |
| EG001 | Cohort A: Ponsegromab 100mg | Participants in Cohort A were randomized to receive ponsegromab 100 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. | 2 | 21 | 7 | 21 | 15 | 21 |
| EG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. | 1 | 17 | 7 | 17 | 11 | 17 |
| EG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. | 13 | 197 | 69 | 197 | 102 | 197 |
| EG004 | Cohort B: Ponsegromab 100mg | Participants in Cohort B were randomized to receive ponsegromab 100 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG005 | Cohort B: Ponsegromab 200mg | Participants in Cohort B were randomized to receive ponsegromab 200 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. | 0 | 9 | 1 | 9 | 3 | 9 |
| EG006 | Cohort B: Ponsegromab 300mg | Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. | 1 | 8 | 2 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Arrhythmic storm | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiac amyloidosis | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ventricular tachyarrhythmia | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Medical device site cellulitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Traumatic ulcer | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Anion gap | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Embolic cerebral infarction | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Vertebral artery stenosis | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Aortic rupture | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Retinal vein thrombosis | Eye disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Device stimulation issue | Product Issues | MedDRA v27.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2024 | Feb 25, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Other |
|
| 55-64 years |
|
| 65-74 years |
|
| 75-84 years |
|
| More than or equal to (>=) 85 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
|
|
|
| OG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
|
|
|
| OG002 |
| Cohort A: Ponsegromab 200mg |
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
|
|
|
| Cohort A: Ponsegromab 200mg |
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period.
|
|
|
| OG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
|
|
|
| OG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
|
|
|
| OG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
|
|
|
| Cohort A: Ponsegromab 200mg |
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
|
|
|
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
|
|
|
| OG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
| OG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
| OG002 | Cohort A: Ponsegromab 200mg | Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
Participants in Cohort A were randomized to receive ponsegromab 200 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
| OG003 | Cohort A: Ponsegromab 300mg | Participants in Cohort A were randomized to receive ponsegromab 300 mg, Q4W from Day 1 to Week 20 (total of 6 doses) of the 22-week double-blind treatment period. |
|
|
| OG002 | Cohort B: Ponsegromab 300mg | Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. |
|
|
| OG002 | Cohort B: Ponsegromab 300mg | Participants in Cohort B were randomized to receive ponsegromab 300 mg SC, Q4W from Day 1 up to Week 12 (total of 4 doses) in the open-label treatment period. |
|
|
|
|