A Phase 2 Study of Sotatercept for Cpc-PH due to HFpEF

UCI Specialty Area: Pulmonology

Principal Investigator: Bassam Yaghmour

Official Title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

A Study On:

Lung - Pulmonary

Study Description

Participants enrolled in the study will have a diagnosis of Cpc-PH due to HFpEF with New York Heart Association (NYHA) functional class (FC) II or III. Participants will be randomly assigned in a 1:1:1 ratio to 1 of the 3 treatment groups (placebo, 0.3mg/kg sotatercept and 0.7mg/kg sotatercept) during the placebo-controlled Treatment Period. In the extension phase, sotatercept-treated participants will continue on their current dose. Placebo participants will be re-randomized in a 1:1 ratio to one of the two sotatercept treatment groups utilized in the placebo-controlled Treatment Period. Each participant will be enrolled in the study for up to 114 weeks, including a 28-day Screening Period, a 24-week, double-blind, placebo-controlled Treatment Period, an 18-month Extension Period, and an 8-week Follow-up Period.

Eligibility

Inclusion Criteria:

Age 18 to 85 years
Clinical diagnosis of HFpEF - Left ventricular ejection fraction greater than or equal to 50%, with no history of LVEF below 45%
Demonstrated Cpc-PH by all of the following:
New York Heart Association FC of II or III
Six-Minute Walk Distance greater than or equal to 100 m repeated twice during Screening and both values within 15% of each other, calculated from the highest value
Chronic medication for HF or for any underlying condition, administered at a stable (per investigator) dose for ≥ 30 days prior to Visit 1. Diuretics and/or anticoagulants are excepted from this rule but should not be newly started or stopped within 30 days of Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1. Anticoagulation may be suspended for RHC if necessary.
Women of childbearing potential must: Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug, If sexually active, have used and agree to continue to use highly effective contraception without interruption for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug, Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug See Appendix 2 for additional contraceptive information.
Male participants must: Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy. Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug
Ability to adhere to the study visit schedule and understand and comply with all protocol requirements
Agreement to not participate in any other trials of investigational drugs/devices while enrolled in the A011-16 study
Ability to understand and provide written informed consent for participation.

Consult the investigator or research personnel for additional information on exclusion criteria.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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