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A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality

Bassam Yaghmour


A Study On:

  • Lung - Pulmonary

Status:

  • Open

Eligibility

Pulmonary Arterial Hypertension
18 Years to 75 Years (Adult, Older Adult)

Interested in joining this trial?

Official Title

A Phase 3, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) Worl Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality

Details

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥24 hours, in participants with WHO FC IV PAH or WHO FC III PAH at high risk of mortality.

Participants with symptomatic PAH (WHO FC III or FC IV at high risk of mortality) who present with idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxin-induced, post-shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defect. Participants must have a Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2 risk score of ≥9 and be on maximum tolerated combination background PAH therapy.


Eligibility

You can join if...

Inclusion Criteria:

  1. Documented diagnostic right heart catheterization prior to screening confirming the diagnosis of World Health Organization (WHO) pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH; Heritable PAH; Drug/toxin-induced PAH; PAH associated with connective tissue diseases (CTD); PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair
    Symptomatic PAH classified as WHO functional class (FC) III or IV
  2. Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2 risk score of ≥9
  3. Right heart catheterization performed during screening (or within 2 weeks prior to screening, if done at the clinical study site) documenting a minimum pulmonary vascular resistance (PVR) of ≥5 Wood units and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤15 mmHg
  4. Clinically stable and on stable doses of maximum tolerated (per investigator's judgment) double or triple background PAH therapies for at least 30 days prior to screening
  5. Females of childbearing potential must:Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy; must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug. If sexually active with a male partner, have used, and agree to use highly effective contraception without interruption per protocol; 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 treatment
  6. 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 treatment
  7. Male participants must:Agree to use a condom, defined as a male latex condom or nonlatex 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 treatment
  8. Ability to adhere to study visit schedule and understand and comply with all protocol requirements
  9. Ability to understand and provide written informed consent

Exclusion Criteria: Consult the study investigator for more information.

Get in touch with our study team