A Long-term Follow-up Study of Sotatercept for PAH Treatment

Phase 1

• Conditions: Pulmonary Arterial Hypertension (PAH); MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005061-13-PT
• Lead Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-07
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 700

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

Participants will be excluded from the study if any of the following criteria are met:
1. Not enrolled in a PAH parent study at the time of enrollment.
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 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH.;Secondary Objective: The secondary objective is to follow participants from parent sotatercept studies that were treated with sotatercept or placebo and assess continued efficacy.;Primary end point(s): The following endpoints will be evaluated as a measure of safety and tolerability:<br>• AEs<br>• Anti-drug antibodies (ADA)<br>• Clinical laboratory assessments (hematology and serum<br>chemistry/FSH, and urinalysis)<br>• Vital signs<br>• 12-lead electrocardiogram (ECG);Timepoint(s) of evaluation of this end point: 24 months and 48 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The following efficacy endpoints will be evaluated:<br>• 6-minute walk distance (6MWD)<br>• N-terminal pro-hormone B-type natriuretic peptide<br>• World Health Organization (WHO) functional class<br>• Pulmonary vascular resistance<br>• Overall survival<br>• Simplified French Risk score;Timepoint(s) of evaluation of this end point: 24 months and 48 months