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C3651011 - A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 4-ARM STUDY TO INVESTIGATE SYMPTOMS, FUNCTION, HEALTH-RELATED QUALITY OF LIFE AND SAFETY WITH REPEATED SUBCUTANEOUS ADMINISTRATION OF PONSEGROMAB VERSUS PLACEBO IN ADULT PARTICIPANTS WITH HEART FAILURE

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509747-27-00
Acronym
C3651011
Enrollment
155
Registered
2024-04-12
Start date
2023-05-18
Completion date
2024-11-27
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Brief summary

Change from baseline in KCCQ-23 CSS at Week 22.

Detailed description

Main Cohort: • Change from baseline in KCCQ-23 OSS, TSS, and physical limitation at Week 22., Main Cohort: • Responses as defined by a ≥5-point increase from baseline in KCCQ-23 CSS, OSS, TSS, and physical limitation at Week 22., Main Cohort: • Change from baseline in 6MWD at Week 22., Main Cohort: • Change from baseline in PROMIS Fatigue 7a at Week 22., Main Cohort: • Incidence of TEAEs, TESAEs, abnormal laboratory results, and vital signs., Open-Label, PK Cohort: • Incidence of TEAEs, TESAEs, abnormal laboratory results, and vital signs.

Interventions

DRUGPonsegromab (PF-06946860)
DRUGPlacebo for ponsegromab (pf-06946860) solution for injection

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in KCCQ-23 CSS at Week 22.—

Secondary

MeasureTime frame
Main Cohort: • Change from baseline in KCCQ-23 OSS, TSS, and physical limitation at Week 22., Main Cohort: • Responses as defined by a ≥5-point increase from baseline in KCCQ-23 CSS, OSS, TSS, and physical limitation at Week 22., Main Cohort: • Change from baseline in 6MWD at Week 22., Main Cohort: • Change from baseline in PROMIS Fatigue 7a at Week 22., Main Cohort: • Incidence of TEAEs, TESAEs, abnormal laboratory results, and vital signs., Open-Label, PK Cohort: • Incidence of TEAEs, TESAEs, abnormal laboratory results, and vital signs.—

Countries

Czechia, Germany, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026