An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Eligible participants must meet the following criteria to be enrolled in the
study:
1. Participants must have completed their current respective PAH sotatercept
clinical study, must have completed the parent study requirements, and must not
have discontinued early.
2. Participants must be willing to adhere to the study visit schedule and
understand and comply with all protocol requirements.
3. Participants must have the ability to understand and provide documented
consent.
4. Females of childbearing potential must:
a. Have a negative pregnancy tests 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.
b. If sexually active, have used, and agree to continue to use highly effective
contraception in combination with a barrier method 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.
c. 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.
5. Male participants must:
a. 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
b. 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.
6. Participants must agree not to participate in any other trials of
investigational drugs/devices while they are enrolled in the A011-12 study

Exclusion Criteria

Participants will be excluded from the study if any of the following criteria
are met:
1. Did not participate in a sotatercept PAH parent trial.
2. Missed more than the equivalent of 4 consecutive doses between the end of
parent study and the start of this study.
3. Presence of an ongoing serious adverse event (SAE) that occurred during a
PAH sotatercept clinical study that is assessed to be possibly or probably
related to sotatercept.
4. Pregnant or breastfeeding females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary (safety) endpoints.<br /><br>The following endpoints will be evaluated as a measure of safety and<br /><br>tolerability:<br /><br>• Adverse events (AEs)<br /><br>• Anti-drug antibodies (ADA)<br /><br>• Clinical laboratory assessments (hematology and serum chemistry /<br /><br>follicle-stimulating hormone (FSH), and urinalysis)<br /><br>• Vital signs<br /><br>• 12-lead electrocardiogram (ECG)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary (Efficacy) endpoints<br /><br>The following efficacy endpoints will be evaluated:<br /><br>• 6-minute walk distance<br /><br>• N-terminal pro-hormone B-type natriuretic peptide<br /><br>• World Health Organization functional class<br /><br>• Pulmonary vascular resistance<br /><br>• Overall survival<br /><br>• Simplified French Risk score</p><br>

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