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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04796337




Registration number
NCT04796337
Ethics application status
Date submitted
22/02/2021
Date registered
12/03/2021
Date last updated
27/11/2024

Titles & IDs
Public title
A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)
Scientific 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
Secondary ID [1] 0 0
A011-12
Secondary ID [2] 0 0
7962-004
Universal Trial Number (UTN)
Trial acronym
SOTERIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
PAH 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sotatercept

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.


Treatment: Other: Sotatercept
Sotatercept subcutaneous injection at a dose of 0.3 to 0.7 mg/kg.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [1] 0 0
Up to approximately 50 months
Primary outcome [2] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [2] 0 0
Up to approximately 50 months
Primary outcome [3] 0 0
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Timepoint [3] 0 0
Up to approximately 50 months
Primary outcome [4] 0 0
Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit
Timepoint [4] 0 0
Up to approximately 50 months
Primary outcome [5] 0 0
Laboratory parameters (Serum Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin
Timepoint [5] 0 0
Up to approximately 50 months
Primary outcome [6] 0 0
Laboratory parameter: Concentration of Follicle Stimulating Hormone (FSH)
Timepoint [6] 0 0
Up to approximately 50 months
Primary outcome [7] 0 0
Change From Baseline in Body Weight
Timepoint [7] 0 0
Baseline and up to approximately 48 months
Primary outcome [8] 0 0
Change From Baseline in Blood Pressure
Timepoint [8] 0 0
Baseline and up to approximately 48 months
Primary outcome [9] 0 0
Change From Baseline in Electrocardiogram (ECG)
Timepoint [9] 0 0
Baseline and up to approximately 48 months
Secondary outcome [1] 0 0
Change From Baseline in 6-Minute Walk Distance (6MWD)
Timepoint [1] 0 0
Baseline and up to approximately 48 months
Secondary outcome [2] 0 0
Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
Timepoint [2] 0 0
Baseline and up to approximately 48 months
Secondary outcome [3] 0 0
Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association (NYHA)/ World Health Organization classification of functional status (WHO FC)
Timepoint [3] 0 0
Baseline and up to approximately 48 months
Secondary outcome [4] 0 0
Change From Baseline in Pulmonary Vascular Resistance (PVR)
Timepoint [4] 0 0
Baseline and up to approximately 48 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to approximately 116 months
Secondary outcome [6] 0 0
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator
Timepoint [6] 0 0
Baseline and up to approximately 48 months
Secondary outcome [7] 0 0
Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score
Timepoint [7] 0 0
Baseline and up to approximately 48 months

Eligibility
Key inclusion criteria
* Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
* Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
* Must have the ability to understand and provide documented 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 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
* 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
* 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
* Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Did not participate in a sotatercept PAH parent trial
* 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 (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
* Pregnant or breastfeeding females

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/02/2031
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital ( Site 1106) - Camperdown
Recruitment hospital [2] 0 0
Saint Vincents Hospital Sydney ( Site 1102) - Darlinghurst
Recruitment hospital [3] 0 0
John Hunter Hospital ( Site 1101) - New Lambton
Recruitment hospital [4] 0 0
The Prince Charles Hospital ( Site 1104) - Brisbane
Recruitment hospital [5] 0 0
Princess Alexandra Hospital ( Site 1108) - Woolloongabba
Recruitment hospital [6] 0 0
Royal Adelaide Hospital ( Site 1109) - Adelaide
Recruitment hospital [7] 0 0
Royal Hobart Hospital ( Site 1107) - Hobart
Recruitment hospital [8] 0 0
Fiona Stanley Hospital ( Site 1103) - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
6150 - Perth
Recruitment outside Australia
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United States of America
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Arizona
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California
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Cordoba
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Argentina
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Santa Fe
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Austria
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Oberosterreich
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Austria
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Steiermark
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Tirol
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Austria
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Wien
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Belgium
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Bruxelles-Capitale, Region De
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Belgium
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Vlaams-Brabant
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Alberta
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Manitoba
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Ontario
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Quebec
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Colombia
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Antioquia
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Cundinamarca
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Splitsko-dalmatinska Zupanija
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Zagrebacka Zupanija
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Czechia
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Praha 2
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Czechia
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Praha 4
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Hovedstaden
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Haute-Garonne
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France
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Herault
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France
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Indre-et-Loire
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France
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Isere
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France
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Loire-Atlantique
Country [67] 0 0
France
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Loire
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France
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Maine-et-Loire
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France
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Meurthe-et-Moselle
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Nord
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Rhone-Alpes
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Vienne
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Bayern
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Hessen
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Petach Tikvah
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Ramat Gan
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Italy
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Lombardia
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Italy
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Napoli
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Italy
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Roma
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Distrito Federal
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Nuevo Leon
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Limburg
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Setubal
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Portugal
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Coimbra
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Portugal
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Lisboa
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Serbia
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Juznobacki Okrug
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Serbia
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Nisavski Okrug
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Serbia
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Sumadijski Okrug
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Serbia
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Beograd
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Spain
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Cantabria
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Spain
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Islas Baleares
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Madrid
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Spain
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Barcelona
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Spain
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Salamanca
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Spain
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Toledo
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Sweden
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Skane Lan
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Uppsala Lan
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Sweden
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Vasterbottens Lan
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Sweden
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Vastra Gotalands Lan
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Switzerland
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Zurich
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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United Kingdom
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Cambridgeshire
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England
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United Kingdom
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Glasgow City
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London, City Of
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United Kingdom
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North Yorkshire
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United Kingdom
State/province [136] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) 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.
Trial website
https://clinicaltrials.gov/study/NCT04796337
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04796337