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A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004) (SOTERIA)

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ClinicalTrials.gov Identifier: NCT04796337
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : November 28, 2022
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Brief Summary:

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) 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 participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.


Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension PAH Biological: Sotatercept Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : November 30, 2027


Arm Intervention/treatment
Experimental: Sotatercept Treatment
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose < 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.
Biological: Sotatercept
Sotatercept subcutaneous injection at a dose of 0.3 to 0.7 mg/kg.
Other Names:
  • ACE-011
  • MK-7962




Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to 200 weeks ]
    The number of participants with AEs will be presented. An AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment.

  2. Number of participants with detectable anti-drug antibodies (ADAs) [ Time Frame: Up to 200 weeks ]
    The number of participants with detectable ADAs will be presented.

  3. Incidence of abnormal hematology laboratory test results [ Time Frame: From date of first visit up to 200 weeks ]
    Based upon complete blood cell count, including red blood cell count, absolute white blood cell count, hemoglobin, hematocrit and platelet count

  4. Incidence of abnormal clinical chemistry laboratory test results [ Time Frame: From date of first visit up to 200 weeks ]
    Based upon blood urea nitrogen, creatinine, total bilirubin, direct bilirubin, AST/ALT, alkaline phosphatase, electrolytes, glucose and carbon dioxide.

  5. Assessment of vital signs - body weight [ Time Frame: From date of first visit up to 200 weeks ]
  6. Assessment of vital signs - blood pressure (systolic/diastolic) [ Time Frame: From date of first visit up to 200 weeks ]
  7. Assessment of vital signs - electrocardiogram (12-lead) for the determination of QTcF interval [ Time Frame: From date of first visit up to 200 weeks ]
  8. Incidence of abnormal urinalysis results [ Time Frame: From date of first visit up to 200 weeks ]
    Based upon dipstick assessment of urine specific gravity, pH, glucose, bilirubin, ketone and protein


Secondary Outcome Measures :
  1. Change in 6-minute walk distance (6MWD) [ Time Frame: From initiation of treatment Visit 1 to year 4 ]
  2. Change in serum N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) [ Time Frame: From initiation of treatment Visit 1 to year 4 ]
  3. Change in WHO Functional Class (FC) [ Time Frame: From initiation of treatment Visit 1 to year 4 ]
  4. Pulmonary vascular resistance (PVR) as determined by right heart catheterization [ Time Frame: Measured at the year 4 Visit ]
  5. Overall Survival (OS) [ Time Frame: From initiation of treatment Visit 1 to the end of study follow-up Visit 8 weeks after year 4 ]
  6. Proportion of participants who maintain or achieve a low risk score using the simplified French Risk score calculator. [ Time Frame: From initiation of treatment Visit 1 to year 4 ]

    Composed of the following parameters:

    • WHO FC (I-II)
    • 6MWD > 440 meters
    • NT-proBNP < 300 ng/L

  7. Change in Borg CR10 Scale (Borg Dyspnea Scale), a measure of exercise tolerance; numerical scale from 0 to 10, with higher number representative of greater exertion. [ Time Frame: From initiation of treatment Visit 1 to year 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must have completed their current respective PAH sotatercept clinical study and its 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 informed consent.
  4. Females of childbearing potential must:

    1. 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.
    2. 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.
    3. 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:

    1. 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.
    2. 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:

  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 serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept.
  4. Pregnant or breastfeeding females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796337


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Show Show 157 study locations
Sponsors and Collaborators
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
ClinicalTrials.gov Identifier: NCT04796337    
Other Study ID Numbers: 7962-004
A011-12 ( Other Identifier: Acceleronpharma )
2020-005061-13 ( EudraCT Number )
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases