BridgeMD
A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality
EU CTIS ID: 2023-509140-10-00
What this study is testing
The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus 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 III or FC IV PAH at high risk of mortality.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age 18 to 75 years, inclusive 2. Documented diagnostic right heart catheterization prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes: • Idiopathic PAH • Heritable PAH • Drug/toxin-induced PAH • PAH associated with CTD • PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair 3. Symptomatic PAH classified as WHO FC III or IV 4. REVEAL Lite 2.0 risk score of ≥ 9 5. Right heart catheterization performed during screening (or within 2 weeks prior to screening, if done at the clinical study site) documenting a minimum PVR of ≥ 5 Wood units and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg 6. 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 7. 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 - Used highly effective contraception without interruption; for at least 28 days prior to starting the investigational product AND - Agree to use the same highly effective contraception in combination with a barrier method during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment 8. 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 9. Ability to adhere to study visit schedule and understand and comply with all protocol requirements 10. Ability to understand and provide written informed consent
You likely can't join if
- 1. Diagnosis of PH WHO Groups 2, 3, 4, or 5 2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus-associated PAH and PAH associated with portal hypertension 3. Diagnosis of pulmonary veno-occlusive diseases or pulmonary capillary hemangiomatosis or overt signs of capillary and/or venous involvement 4. Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test 5. Baseline platelet count < 50,000/mm3 (< 50.0 x 109/L) at screening 6. Baseline systolic blood pressure < 85 mmHg at Screening 7. Pregnant or breastfeeding women 8. Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels > 3.0 × ULN 9. Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 halflives for biologics prior to the date of signed informed consent 10.Prior exposure to sotatercept or known allergic reaction to sotatercept, its excipients, or luspatercept 11. History of pneumonectomy 12.This criterion has been removed 13.Untreated more than mild obstructive sleep apnea 14.History of known pericardial constriction 15.History of restrictive or congestive cardiomyopathy 16.Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 500 ms during the Screening Period 17.Personal or family history of long QT syndrome or sudden cardiac death 18.Left ventricular ejection fraction < 45% on historical echocardiogram within 1 year prior to the Screening Visit 19.Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit 20.Cerebrovascular accident within 3 months prior to the Screening Visit 21.Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease 22.Currently on dialysis or anticipated need for dialysis within the next 12 months
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Mexico
- United States
- Australia
- United Kingdom
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Mexico; United States; Australia; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.