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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04811092
Registration number
NCT04811092
Ethics application status
Date submitted
16/03/2021
Date registered
23/03/2021
Date last updated
31/05/2024
Titles & IDs
Public title
Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
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Secondary ID [1]
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A011-13
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Secondary ID [2]
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7962-005
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Universal Trial Number (UTN)
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Trial acronym
HYPERION
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sotatercept
Other interventions - Placebo
Placebo Comparator: Placebo plus background PAH therapy - Administered subcutaneously (SC) every 21 days plus background PAH therapy
Experimental: Sotatercept plus background PAH therapy - Administered at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy
Treatment: Drugs: Sotatercept
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1
Other interventions: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Clinical Worsening
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Assessment method [1]
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Time to clinical worsening is defined as time from randomization to the first confirmed morbidity event or death. Clinical worsening events are defined as all-cause death, non-planned PAH-related hospitalization of = 24 hours in duration, atrial septostomy, lung transplant and deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO functional class from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral. All events will be adjudicated by a blinded, independent committee of clinical experts.
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Timepoint [1]
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From time of randomization to the time of first clinical worsening event (Up to approximately 47 months)
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Secondary outcome [1]
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Percentage of Participants Achieving the Multicomponent Improvement Endpoint of 6-Minute Walk Distance (6MWD), N-terminal prohormone Btype natriuretic peptide (NT-ProBNP) and World Health Organization (WHO) Functional Class (FC)
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Assessment method [1]
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Multicomponent improvement endpoint measured by the percentage of participants achieving all of the following at Week 24 relative to baseline:
Improvement in 6MWD
Improvement or maintenance/achievement of NT-proBNP
Improvement in WHO FC or maintenance of WHO FC II
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [2]
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Percentage of Participants who Achieved a Low Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 Risk Score
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Assessment method [2]
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The REVEAL Lite 2 uses renal insufficiency (by estimated glomerular filtration rate (eGFR)), WHO FC, systolic blood pressure (SBP) and heart rate, 6MWD, and NT-proBNP to determine the total risk score. The scores (range: 1-14) can be defined as: low risk as a score of =5, intermediate risk as a score of 6 or 7, and high risk as a score of =8 for the survival rates.
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Percentage of Participants who Maintain or Achieve a Low Simplified French Risk Score
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Assessment method [3]
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The simplified French Risk Score uses WHO FC, 6MWD, and NT-proBNP to determine the total risk score. A low risk score can be defined as attaining or maintaining all three low-risk criteria: WHO FC I or II, 6MWD > 440m, and NT-proBNP < 300 ng/L. The percentage of participants who maintain or achieve a low risk score at Week 24 versus baseline using the simplified French Risk score calculator will be reported.
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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Change from Baseline in NT-proBNP Levels
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Assessment method [4]
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Blood samples will be collected at baseline and at Week 24 to measure NT-proBNP blood concentration.
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Timepoint [4]
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Baseline and Week 24
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Secondary outcome [5]
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Percentage of Participants who Improve in WHO FC or Maintain WHO FC II at 24 Weeks from Baseline
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Assessment method [5]
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The severity of an individual's PAH symptoms was graded using the WHO FC system. WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO FC is classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC.
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Change from Baseline in 6MWD
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Assessment method [6]
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The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. Change from baseline in 6MWD at Week 24 will be reported.
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Timepoint [6]
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Baseline and Week 24
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Secondary outcome [7]
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Change from Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT)®
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Assessment method [7]
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PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported.
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Timepoint [7]
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Baseline and Week 24
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Secondary outcome [8]
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Change from Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT®
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Assessment method [8]
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PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported.
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Timepoint [8]
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Baseline and Week 24
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Secondary outcome [9]
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Change from Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT®
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Assessment method [9]
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PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported
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Timepoint [9]
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Baseline and Week 24
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Eligibility
Key inclusion criteria
Eligible participants must meet all of the following criteria to be enrolled in the study:
1. Age = 18 years
2. Documented diagnostic right heart catheterization (RHC) within 12 months of screening
documenting a minimum PVR of = 4 Wood units and pulmonary capillary wedge pressure
(PCWP) or left ventricular end-diastolic pressure (LVEDP) of = 15 mmHg, with the
diagnosis of WHO PAH Group 1 in any of the following subtypes:
- Idiopathic PAH
- Heritable PAH
- Drug/toxin-induced PAH
- PAH associated with connective tissue disease
- PAH associated with simple, congenital systemic to pulmonary shunts at least 1
year following repair
3. Symptomatic PAH classified as WHO FC II or III
4. Either Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2
Risk Score = 6 or Comparative, Prospective Registry of Newly Initiated Therapies for
Pulmonary Hypertension (COMPERA) 2.0 risk score =2 (intermediate to-low-risk or above)
5. Diagnosis of PAH within 12 months of screening and on stable doses of a double or
triple combination of background PAH therapies and diuretics (if any) for at least 90
days prior to screening
6. Six-minute walk distance = 150 m repeated twice at screening at least 4 hours apart,
but no longer than 1 week apart, and both values are within 15% of each other
(calculated from the highest value)
7. Females of childbearing potential must meet the following criteria:
- Have 2 negative urine or serum pregnancy tests as verified by the investigator
prior to starting study drug administration; she must agree to ongoing urine or
serum pregnancy testing during the course of the study and until 8 weeks after
the last dose of the study drug
- If sexually active with a male partner, have used highly effective contraception
without interruption, for at least 28 days prior to starting the investigational
product AND agreed to use the same highly effective contraception in combination
with a barrier method during the study (including dose interruptions) and for 16
weeks (112 days) after discontinuation of study treatment
- 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 treatment
8. Male participants must meet the following criteria:
- Agree to use a condom, defined as a male latex condom or nonlatex 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 treatment
9. Ability to adhere to study visit schedule and understand and comply with all protocol
requirements
10. Ability to understand and provide written informed consent
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded from the study if any of the following criteria are met:
1. Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus
(HIV)-associated PAH and PAH associated with portal hypertension,
schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary
capillary hemangiomatosis
3. Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local
laboratory test
4. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
(BP) > 180 mmHg or sitting diastolic BP > 110 mmHg during the Screening Visit after a
period of rest
5. Baseline systolic BP < 90 mmHg at screening
6. Pregnant or breastfeeding women
7. Any of the following clinical laboratory values at the Screening Visit:
- Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (as defined by MDRD
equation)
- Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin
levels > 3 × ULN
- Platelet count < 50,000/mm3 (< 50.0 × 109 /L)
8. Currently enrolled in or have completed any other investigational product study within
30 days for small molecule drugs or within 5 half-lives for investigational biologics
prior to the date of documented informed consent
9. Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
10. History of pneumonectomy
11. Pulmonary function test values of forced vital capacity < 60% predicted within 1 year
prior to the Screening Visit
12. Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen,
anticoagulants, and digoxin) within 60 days prior to the Screening Visit
13. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days
prior to the Screening Visit or planned initiation during the study (participants who
are stable in the maintenance phase of a program and who will continue for the
duration of the study are eligible)
14. Untreated more than mild obstructive sleep apnea
15. History of known pericardial constriction
16. History of restrictive or congestive cardiomyopathy
17. History of atrial septostomy within 180 days prior to the Screening Visit
18. Electrocardiogram with Fridericia's corrected QT interval > 500 ms during the
Screening Period
19. Personal or family history of long QT syndrome or sudden cardiac death
20. Left ventricular ejection fraction < 50% on historical echocardiogram (ECHO) within 1
year prior to the Screening Visit
21. Any current or prior history of symptomatic coronary disease (prior myocardial
infarction, percutaneous coronary intervention, coronary artery bypass graft surgery,
or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit
22. Cerebrovascular accident within 3 months prior to the Screening Visit
23. Acutely decompensated heart failure within 30 days prior to the Screening Visit, as
per investigator assessment
24. Significant (= 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular
disease
25. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and
vasopressin) within 30 days prior to the Screening Visit
26. Has an active malignancy with the exception of fully excised or treated basal cell
carcinoma, cervical carcinoma in-situ, or prostate cancer that is not currently or
expected, during the study, to be treated with radiation therapy, chemotherapy, and/or
surgical intervention, or hormonal treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/12/2029
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Actual
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Sample size
Target
444
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital ( Site 1106) - Camperdown
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John Hunter Hospital ( Site 1101) - Newcastle
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Prince Charles Hospital ( Site 1104) - Chermside
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Princess Alexandra Hospital ( Site 1108) - Woolloongabba
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Royal Adelaide Hospital ( Site 1109) - Adelaide
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Royal Hobart Hospital ( Site 1107) - Hobart
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Fiona Stanley Hospital ( Site 1103) - Murdoch
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2308 - Newcastle
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4032 - Chermside
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4102 - Woolloongabba
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5000 - Adelaide
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7000 - Hobart
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment outside Australia
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Ashdod
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Israel
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Israel
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Ramat Gan
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Italy
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Italy
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Italy
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Monza E Brianza
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Italy
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Italy
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Incheon
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Kyonggi-do
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Seoul
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Netherlands
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Gelderland
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Limburg
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Waikato
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Setubal
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Portugal
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Portugal
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Serbia
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Serbia
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Beograd
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Islas Baleares
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Madrid
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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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Sweden
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Uppsala Lan
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Sweden
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Zurich
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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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United Kingdom
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Derbyshire
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United Kingdom
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Glasgow City
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United Kingdom
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London, City Of
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United Kingdom
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Newcastle Upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
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Summary
Brief summary
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly
called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy)
versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in
participants who are newly diagnosed with PAH and are at intermediate or high risk of disease
progression.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04811092
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Public notes
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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1-888-577-8839
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04811092
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