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 (SOTERIA)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2027
  • participants needed
    700
  • sponsor
    Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Updated on 21 October 2022

Summary

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in PAH.

Description

This Long-term Follow-up Study (LTFU) study is supported by data from the PULSAR study in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin.

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 subject with PAH who have completed prior sotatercept studies.

The secondary objective is to evaluate continued efficacy in adult subject with PAH who have completed prior sotatercept studies.

Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies

Details
Condition PAH
Treatment Sotatercept
Clinical Study IdentifierNCT04796337
SponsorAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible participants must meet the following criteria to be enrolled in the
study
Participants must have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
Participants must have the ability to understand and provide written informed consent
Females of childbearing potential must
Have a negative pregnancy test 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
If sexually active, have used, and agree to continue to use highly effective contraception 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
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
See Appendix 4 for additional contraceptive information
\. Male participants must
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
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
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
Not enrolled in a PAH parent study at the time of enrollment
Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study
Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
Pregnant or breastfeeding females
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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