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

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ClinicalTrials.gov Identifier: NCT04796337
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma Inc.

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

Condition or disease Intervention/treatment Phase
PAH Biological: sotatercept Phase 3

Detailed 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

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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 2027
Estimated Study Completion Date : November 2027


Arm Intervention/treatment
Experimental: sotatercept
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 injection
Other Name: ACE-011




Primary Outcome Measures :
  1. Frequency of adverse events (AEs) [ Time Frame: From date of first visit up to 200 weeks ]
  2. Proportion of study participants with detectable anti-drug antibodies (ADA ) [ Time Frame: From date of first visit up to 200 weeks ]
  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

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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:

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 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 written 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 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.

    See Appendix 4 for additional contraceptive information.

  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:

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 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: Clinical Trial Manager 617-649-9200 clinicaltrials011@acceleronpharma.com

Locations
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United States, Arizona
Arizona Pulmonary Specialists Recruiting
Phoenix, Arizona, United States, 85012
Contact: Nidhi Samaraweera    602-271-0832    nidhi-research@hotmail.com   
Contact: Lorraine Stroud    (602) 271-0832    lorraine-research@hotmail.com   
Principal Investigator: Jeremy Feldman, MD         
Pulmonary Associates P.A. Recruiting
Phoenix, Arizona, United States, 85032
Contact: Liyi Fu    602-258-4951    l.fu@pulmonaryassociates.com   
Contact: Vincent DeLaCruz    (602) 346-4742    vince@pulmonaryassociates.com   
Principal Investigator: David Baratz, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kimberly Cygan    913-588-3855    kcygan@kumc.edu   
Principal Investigator: Leslie Spikes, MD         
United States, Massachusetts
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Olivia Grace Vayer    917-620-4191    ovayer@bwh.harvard.edu   
Contact: Rachel Vercillo    (917) 620-4191      
Principal Investigator: Aaron Waxman, MD, PhD         
United States, Ohio
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Roxanne Robertson    513-585-1777    roxanne.robertson@thechristhospital.com   
Contact: Terri Sikora    (513) 585-8177 x7    terri.sikora@thechristhospital.com   
Principal Investigator: Peter Engel, MD, FACC         
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel, 78306
Principal Investigator: Amir Bar-Shai, MD         
Rabin Medical Center - PPDS Recruiting
Petah Tikva, Israel, 49100
Contact: Liora Yehoshua    +97239377214    lioray@clalit.org.il   
Contact: Hilla Levi    +97236249923    hillale1@clalit.org.il   
Principal Investigator: Morchedai Kramer, MD         
Sheba Medical Center - PPDS Recruiting
Ramat-Gan, Israel, 52621
Contact: Ariela Velner    +97235302841    ariela.velner@sheba.health.gov.il   
Contact: Oshrat Yona    +972542574848    oshrat.yona@sheba.health.gov.il   
Principal Investigator: Michael Segel, MD         
Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28401
Contact: Nuria Ochoa    +34917792642    nuriaochoaparra@hotmail.com   
Contact: Guillermo Moreno    +34917792642    guimoren@ucm.es   
Principal Investigator: Maria Pilar Escribano Subias, MD, PhD         
Sponsors and Collaborators
Acceleron Pharma Inc.
Investigators
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Study Director: Jonathan Lu, MD, PhD Acceleron Pharma Inc.
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Responsible Party: Acceleron Pharma Inc.
ClinicalTrials.gov Identifier: NCT04796337    
Other Study ID Numbers: A011-12
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No