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NCT07140484RecruitingPhase 4

Sotatercept in Pulmonary Arterial Hypertension

A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)

Source: ClinicalTrials.gov · Last updated 9 Jul 2026

Brief summary (registry, in English)

The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. Participants will be asked to: * Take Sotatercept every 21 days (±3 days) * Each participant will be enrolled in the study for 29 Weeks * Visit the clinic 18 times * Have a physical exam * Perform assessments of lung function and exercise tests * Have an ultrasound of their heart * Have blood draws done at regular intervals The main objectives of the study are: Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise. Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
27 (estimated)
First submitted
8 Aug 2025
Start date
6 Oct 2025
Primary completion date
1 Jan 2029
Lead sponsor
University of Alberta
NCT number
NCT07140484

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 27
  • From 6 Oct 2025 to the primary completion date, 1 Jan 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent.
  • Pulmonary function test (PFT) values of forced vital capacity (FVC) \< 60% predicted and/or FEV1/FVC \< lower limit of normal at the screening visit or within 6 months prior to the screening visit.
  • Smoking history of ≥ 20 pack-years or any tobacco smoking or vaping within the previous 3 months.
  • History of atrial septostomy within 180 days prior to the screening visit.
  • Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions.
  • Cerebrovascular accident within 3 months prior to the Screening Visit.
  • Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit.

Other illness

  • 1\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
  • Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.
  • Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \> 160 mmHg or sitting diastolic blood pressure \> 100 mmHg during a screening visit after a period of rest.
  • History of full pneumonectomy.
  • Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).
  • History of restrictive, constrictive, or congestive cardiomyopathy.
  • Known hypersensitivity to sotatercept or to any ingredient in the formulation or component of the container.

Lab values

  • Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.
  • Baseline platelet count \< 50,000/mm3 (\< 50.0 × 109/L) in the enrollment period.
  • Any of the following clinical laboratory values at the screening visit:
    • Estimated glomerular filtration rate (eGFR) \< 30 mL/min/m2 (as defined by the Modification of Diet in Renal Disease \[MDRD\] equation)
    • Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \> 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome).
  • Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \> 500 ms during the Screening Period
  • Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
  • Left ventricular ejection fraction \< 45% on historical echocardiogram within 6 months prior to the screening visit.

Other

  • Musculoskeletal limitation that precludes participation in cycle ergometry
  • Resting oxygen saturation \< 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).
  • Baseline systolic blood pressure \< 90 mmHg at screening.
  • Pregnant or breastfeeding women.
  • Body mass index ≥ 40 kg/m2.
  • Planned initiation of an exercise program for cardiopulmonary rehabilitation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
  • Significant mitral or aortic valve dysfunction (greater than moderate mitral regurgitation or aortic regurgitation, or greater than mild mitral stenosis or aortic stenosis).

Criteria the registry did not label

  • Eligible participants must meet all of the following inclusion criteria to be enrolled in the study:
  • Age ≥ 18 years.
  • Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of 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.
  • Symptomatic PAH classified as WHO FC II or III.
  • On stable doses of ≥2 background PAH therapies for at least 60 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of the optimal dose is allowed per medical practice. Patients on 1 background PAH therapy are eligible if there is documented intolerance or contraindication to use of the other 2 classes (e.g. liver enzyme elevation while taking an ERA).
  • Females of childbearing potential must:
    • Have a negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy.
    • If sexually active, have used, and agree to use highly effective contraception without interruption during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment.
    • 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.
  • 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
  • Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
  • Ability to understand and provide written informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Physiology Laboratory
Coordinator of this site? Confirm its status		EdmontonCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.