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

Sponsor
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04796337
Collaborator
(none)
700
Enrollment
116
Locations
1
Arm
78.6
Anticipated Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Sep 30, 2027
Anticipated Study Completion Date :
Nov 30, 2027

Arms and Interventions

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 Names:
  • ACE-011

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of adverse events (AEs) [From date of first visit up to 200 weeks]

    2. Proportion of study participants with detectable anti-drug antibodies (ADA ) [From date of first visit up to 200 weeks]

    3. Incidence of abnormal hematology laboratory test results [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 [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 [From date of first visit up to 200 weeks]

    6. Assessment of vital signs - blood pressure (systolic/diastolic) [From date of first visit up to 200 weeks]

    7. Assessment of vital signs - electrocardiogram (12-lead) for the determination of QTcF interval [From date of first visit up to 200 weeks]

    8. Incidence of abnormal urinalysis results [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) [From initiation of treatment Visit 1 to year 4]

    2. Change in serum N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) [From initiation of treatment Visit 1 to year 4]

    3. Change in WHO Functional Class (FC) [From initiation of treatment Visit 1 to year 4]

    4. Pulmonary vascular resistance (PVR) as determined by right heart catheterization [Measured at the year 4 Visit]

    5. Overall Survival (OS) [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. [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. [From initiation of treatment Visit 1 to year 4]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    5. 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.

    6. 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.

    7. 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.

    1. Male participants must:

    2. 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.

    3. 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.

    4. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Pulmonary Specialists ( Site 1010) Phoenix Arizona United States 85012-2369
    2 Pulmonary Associates, PA ( Site 1008) Phoenix Arizona United States 85032
    3 University of Arizona ( Site 1006) Tucson Arizona United States 85724
    4 University of California San Diego ( Site 1002) La Jolla California United States 92037
    5 University of California San Francisco ( Site 1019) San Francisco California United States 94118
    6 University of Colorado Hospital ( Site 1013) Aurora Colorado United States 80045
    7 The George Washington University Medical Faculty Associates ( Site 1025) Washington District of Columbia United States 20037
    8 AdventHealth Orlando ( Site 1058) Orlando Florida United States 32803
    9 Tufts Medical Center - PPDS ( Site 1012) Boston Massachusetts United States 02111-1526
    10 Brigham & Women's Hospital ( Site 1014) Boston Massachusetts United States 02115
    11 University of Michigan ( Site 1011) Ann Arbor Michigan United States 48109-5936
    12 University of Kansas Medical Center ( Site 1020) Kansas City Missouri United States 66160-7232
    13 University of Nebraska Medical Center ( Site 1053) Omaha Nebraska United States 68118
    14 Duke University Medical Center ( Site 1026) Durham North Carolina United States 27710
    15 The Lindner Center for Research and Education at The Christ Hospital ( Site 1001) Cincinnati Ohio United States 45219
    16 University of Cincinnati ( Site 1035) Cincinnati Ohio United States 45267
    17 The Ohio State University Wexner Medical Center ( Site 1032) Columbus Ohio United States 43221
    18 Rhode Island Hospital ( Site 1033) Providence Rhode Island United States 02903
    19 Medical University of South Carolina - PPDS ( Site 1003) Mount Pleasant South Carolina United States 29464-3771
    20 Statcare Pulmonary Consultants - Knoxville ( Site 1031) Knoxville Tennessee United States 37919
    21 Houston Methodist Hospital ( Site 1009) Houston Texas United States 77030
    22 Instituto de Investigaciones Clinicas Quilmes ( Site 1903) Quilmes Buenos Aires Argentina B1878GEG
    23 Centro Medico Dra De Salvo ( Site 1904) Ciudad Autonoma de Buenos Aires Caba Argentina C1426ABP
    24 Instituto Médico DAMIC ( Site 1909) Córdoba Cordoba Argentina X5003DCE
    25 Instituto Medico Rio Cuarto ( Site 1907) Rio Cuarto Cordoba Argentina X5800AEV
    26 Hospital Provincial del Centenario ( Site 1912) Rosario Santa Fe Argentina 2002
    27 Instituto Cardiovascular de Rosario ( Site 1906) Rosario Santa Fe Argentina S2000DSR
    28 Centro Oncologico de Rosario ( Site 1905) Rosario Santa Fe Argentina S2000DSV
    29 Hospital Universitario Austral ( Site 1901) Buenos Aires Argentina B1629AHJ
    30 Sanatorio Allende ( Site 1908) Cordoba Argentina X5000JHQ
    31 Hospital Dr. Jose Maria Cullen ( Site 1902) Santa Fe Argentina S3000EOZ
    32 Royal Prince Alfred Hospital ( Site 1106) Camperdown New South Wales Australia 2050
    33 Saint Vincents Hospital Sydney ( Site 1102) Darlinghurst New South Wales Australia 2010
    34 John Hunter Hospital ( Site 1101) New Lambton New South Wales Australia 2305
    35 The Prince Charles Hospital ( Site 1104) Brisbane Queensland Australia 4032
    36 Royal Hobart Hospital ( Site 1107) Hobart Tasmania Australia 7000
    37 Fiona Stanley Hospital ( Site 1103) Murdoch Western Australia Australia 6150
    38 Erasme Hospital ( Site 1402) Bruxelles Bruxelles-Capitale, Region De Belgium 1070
    39 UZ Gasthuisberg ( Site 1401) Leuven Vlaams-Brabant Belgium 3000
    40 Hospital Madre Teresa ( Site 1804) Belo Horizonte Minas Gerais Brazil 30430-142
    41 Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805) Porto Alegre Rio Grande Do Sul Brazil 90035-074
    42 Hospital São Lucas da PUCRS ( Site 1801) Porto Alegre Rio Grande Do Sul Brazil 90610-000
    43 Hospital Dia do Pulmao ( Site 1802) Blumenau Santa Catarina Brazil 89010-000
    44 Hospital Sao Paulo ( Site 1806) São Paulo Sao Paulo Brazil 04038-031
    45 Instituto do Coracao - HCFMUSP ( Site 1803) Sao Paulo Brazil 05403-000
    46 Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201) Praha 2 Czechia 128 08
    47 Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202) Praha 4 Czechia 140 21
    48 Rigshospitalet ( Site 3802) København Ø Hovedstaden Denmark 2100
    49 Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311) Nice Alpes-Maritimes France 06001
    50 Hopital Civil - CHU Strasbourg ( Site 1307) Strasbourg Bas-Rhin France 67000
    51 CHRU Brest - Hopital Cavale Blanche ( Site 1314) Brest Finistere France 29200
    52 Groupe Hospitalier Sud ( Site 1312) Pessac Gironde France 33600
    53 CHU de Toulouse - Hopital Larrey ( Site 1315) Toulouse Haute-Garonne France 31059
    54 Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301) Montpellier Herault France 34090
    55 C.H.U. de Tours - Hopital Bretonneau ( Site 1310) Tours Indre-et-Loire France 37000
    56 C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303) La Tronche Isere France 38700
    57 Hopital Nord Laennec ( Site 1309) Nantes Loire-Atlantique France 44800
    58 Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302) Saint-Priest-en-Jarez Loire France 42055
    59 CHU Angers ( Site 1313) Angers Maine-et-Loire France 49100
    60 C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308) Vandoeuvre Les Nancy Meurthe-et-Moselle France 54500
    61 CHRU Lille ( Site 1306) Lille Nord France 59037
    62 Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317) Bron Rhone-Alpes France 69677
    63 CHU - Hopital de Bicetre ( Site 1304) Le Kremlin Bicetre Val-de-Marne France 94270
    64 Thoraxklinik-Heidelberg gGmbH ( Site 1509) Heidelberg Baden-Wurttemberg Germany 69126
    65 Krankenhaus Neuwittelsbach ( Site 1510) Muenchen Bayern Germany 80639
    66 Universitaetsklinik Regensburg ( Site 1503) Regensburg Bayern Germany 93053
    67 Universitätsklinikum Gießen und Marburg GmbH ( Site 1512) Gießen Hessen Germany 35392
    68 Medizinische Hochschule Hannover ( Site 1505) Hannover Niedersachsen Germany 30625
    69 Universitätsklinik Köln ( Site 1511) Cologne Nordrhein-Westfalen Germany 50931
    70 Universataet des Saarlandes ( Site 1513) Homburg Saarland Germany 66424
    71 Universitätsklinikum Halle ( Site 1502) Halle Sachsen-Anhalt Germany 06120
    72 Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501) Dresden Sachsen Germany 01307
    73 Universitatsklinikum Leipzig ( Site 1508) Leipzig Sachsen Germany 04103
    74 DRK Kliniken Berlin Westend ( Site 1507) Berlin Germany 14050
    75 Evangelismos General Hospital of Athens ( Site 3605) Athina Attiki Greece 106 76
    76 Barzilai Medical Center ( Site 1708) Ashkelon Israel 7830604
    77 Lady Davis Carmel Medical Center ( Site 1705) Haifa Israel 34362
    78 Hadassah Medical Center ( Site 1711) Jerusalem Israel 9112001
    79 Meir Medical Center ( Site 1707) Kfar Saba Israel 4428164
    80 Rabin Medical Center ( Site 1703) Petach Tikvah Israel 4941492
    81 Sheba MC ( Site 1701) Ramat Gan Israel 5265601
    82 Ospedale S. Giuseppe Multimedica ( Site 2403) Milano Lombardia Italy 20123
    83 Universita "La Sapienza" Policlinico Umberto I ( Site 2402) Roma Italy 00161
    84 Chonnam National University Hospital ( Site 3105) Gwangju Kwangju-Kwangyokshi Korea, Republic of 61469
    85 Gachon University Gil Medical Center ( Site 3103) Incheon Korea, Republic of 21565
    86 Seoul National University Hospital ( Site 3102) Seoul Korea, Republic of 03080
    87 Samsung Medical Center ( Site 3106) Seoul Korea, Republic of 06351
    88 The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 3104) Seoul Korea, Republic of 06591
    89 Erasmus MC ( Site 2604) Rotterdam Gelderland Netherlands 3015 GJ
    90 Maastricht University Medical Center ( Site 2603) Maastricht Limburg Netherlands 6229 HX
    91 VU Medisch Centrum ( Site 2601) Amsterdam Noord-Holland Netherlands 1081 HV
    92 Waikato District Health Board ( Site 2702) Hamilton Waikato New Zealand 3240
    93 Greenlane Clinical Centre ( Site 2703) Auckland New Zealand 1051
    94 Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801) Krakow Malopolskie Poland 31-202
    95 Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 2802) Otwock Mazowieckie Poland 05-400
    96 Hospital Garcia de Orta ( Site 3501) Almada Setubal Portugal 2801-267
    97 Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 3503) Lisboa Portugal 1769-001
    98 University Clinical Center Nis ( Site 2904) Nis Nisavski Okrug Serbia 1800
    99 Hospital Universitario Marques de Valdecilla ( Site 1601) Santander Cantabria Spain 39008
    100 Hospital Universitario de Son Espases ( Site 1611) Palma de Mallorca Islas Baleares Spain 07120
    101 Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604) Majadahonda Madrid Spain 28222
    102 Hospital Universitari Vall d'Hebron ( Site 1605) Barcelona Spain 08035
    103 Hospital Clinic de Barcelona ( Site 1602) Barcelona Spain 08036
    104 Hospital Universitario Ramon y Cajal ( Site 1609) Madrid Spain 28034
    105 Hospital Universitario 12 de Octubre ( Site 1603) Madrid Spain 28041
    106 Hospital Universitario La Paz ( Site 1610) Madrid Spain 28046
    107 Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608) Salamanca Spain 37007
    108 Skanes Universitetssjukhus Lund ( Site 3203) Lund Skane Lan Sweden 221 85
    109 Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204) Uppsala Uppsala Lan Sweden 751 85
    110 Norrlands Universitetssjukhus ( Site 3205) Umeå Vasterbottens Lan Sweden 907 37
    111 Sahlgrenska Universitetssjukhuset ( Site 3201) Goteburg Vastra Gotalands Lan Sweden 413 45
    112 Universitaetsspital Zurich ( Site 3301) Zuerich Zurich Switzerland 8091
    113 Golden Jubilee National Hospital ( Site 1204) Glasgow Glasgow City United Kingdom G81 2DR
    114 Royal Free London NHS Foundation Trust ( Site 1202) London London, City Of United Kingdom NW3 2QG
    115 Royal Brompton Hospital ( Site 1206) London London, City Of United Kingdom SW3 6NP
    116 Imperial College Healthcare NHS Trust ( Site 1203) London London, City Of United Kingdom W2 1PG

    Sponsors and Collaborators

    • Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    • 2020-005061-13
    First Posted:
    Mar 12, 2021
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 23, 2022