A Study of Ponsegromab in People With Heart Failure

Phase 2

Recruiting

• Conditions: Heart Failure

• Registration Number: JPRN-jRCT2051220111
• Lead Sponsor: Kawai Norisuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

Male and female participants aged 18 years or older
Clinical evidence of HF with each of the following criteria:
1.LVEF <50% on most recent measurement, within 12 months of screening.
2.NYHA class II-IV at screening.
3.NT-proBNP >=400 pg/mL at screening.
Serum GDF-15 concentration >=2000 pg/mL at screening.
KCCQ-23 CSS <75 at screening.
Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following at screening:

1.Non-edematous unintentional weight loss >=5% in the last 6 months or current BMI <20 kg/m2, associated with subjective fatigue or anorexia; or
2.Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks based on the KCCQ-23 administered at screening; or
3.A score of <60 on the Physical Limitations Domain of the KCCQ 23 administered at screening.

Exclusion Criteria

Acute decompensated HF within 1 month prior to Screening Visit 1 or during the screening period.
Implantation of a cardiac resynchronization therapy device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial.
History of heart transplantation, currently listed for heart transplant, current/planned mechanical circulatory support, or current/planned use of intravenous inotropes (eg, dobutamine, milrinone).
Acute coronary syndrome within 1 month prior to randomization.
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 3 months prior to randomization or intent to undergo coronary revascularization during the trial.
Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm abnormality (ie, tachyarrhythmia or bradyarrhythmia).
Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of study intervention used in this study. Treatment with an investigational biologic agent within 6 months or 5 half-lives (whichever is longer) of Day 1.
Previous exposure to ponsegromab in a prior clinical study.
Renal disease requiring ongoing dialysis.
Cirrhosis with evidence of portal hypertension not due to HF, or the following LFT abnormalities at the time of screening, confirmed by a repeat test if deemed necessary: AST or ALT level >= 3 x ULN, or total bilirubin level >= 2 x ULN (unless history of Gilbert's syndrome).

Study & Design

• Study Type: Interventional
• Study Design: Not specified