A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:June 27, 2018
End Date:November 2021
Contact:Clinical Trial Manager
Email:clinicaltrials011@acceleronpharma.com
Phone:617-649-9200

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A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)

Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011)
relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible
participants will receive study treatment for 6 months in the Placebo-Controlled Treatment
Period, and then will be eligible to enroll into an 18- month Extension Period during which
all participants will receive sotatercept. All treated patients will be also undergo
follow-up period after last study drug treatment.

This is a Phase 2, double blind, randomized, placebo-controlled, parallel-group study of
sotatercept plus SOC versus placebo plus SOC in participants with PAH of WHO Group 1,
functional class II-III.

Participants will be randomly assigned in a 3:3:4 ratio to receive placebo every 21 days,
sotatercept 0.3 mg/kg subcutaneously (SC) every 21 days, or sotatercept 0.7 mg/kg SC every 21
days, for a period of 24 weeks in the Placebo-Controlled Treatment Period of the study while
on standard of care therapy. Evaluations will include changes in pulmonary vascular
resistance (PVR), six-minute-walk distance (6MWD), quality of life questionnaires,
echocardiographic parameters, and safety. Participants who have not discontinued early from
the Placebo-Controlled Treatment Period and have had their post-Treatment Period PVR
assessment will be able to continue into the 18-month Extension Period in which
sotatercept-treated participants will receive their latest dose level of sotatercept SC every
21 days and placebo-treated participants willbe re-randomized 1:1 to receive sotatercept 0.3
mg/kg SC every 21 days or sotatercept 0.7 mg/kg SC every 21 days while on standard of care
therapy.

Inclusion Criteria:

1. Age ≥ 18 years

2. Documented diagnostic right heart catheterization (RHC) at any time prior to Screening
confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH in any of
the following subtypes:

- Idiopathic

- Heritable PAH

- Drug- or toxin-induced PAH

- PAH associated with connective tissue disease

- PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1
year following shunt repair

3. Symptomatic pulmonary hypertension classified as WHO functional class II or III

4. Screening RHC documenting a minimum PVR of ≥ 400 dyn·sec/cm5 (5 Wood units)

5. Pulmonary function tests (PFTs) within 6 months prior to Screening as follows:

1. Total lung capacity (TLC) > 70% predicted; or if between 60 to70% predicted, or
not possible to be determined, confirmatory high-resolution computed tomography
(CT) indicating no more than mild interstitial lung disease (ILD), per
investigator interpretation, or

2. Forced expiratory volume (first second) (FEV1)/ forced vital capacity (FVC) > 70%
predicted

6. Ventilation-perfusion (VQ) scan (or, if unavailable a negative CT pulmonary angiogram
[CTPA] result, or pulmonary angiography result), any time prior to Screening Visit or
conducted during the Screening Period, with normal or low probability result),

7. No contraindication per investigator for RHC during the study

8. 6MWD ≥ 150 and ≤ 550 meters repeated twice at Screening and both values within 15% of
each other, calculated from the highest value

9. PAH therapy at stable (per investigator) dose levels of SOC therapies

Exclusion Criteria:

1. Stopped receiving any pulmonary hypertension chronic general supportive therapy (e.g,
diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to study visit C1D1

2. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine,
vasopressin) within 30 days prior to study visit C1D1

3. History of atrial septostomy within 180 days prior to Screening

4. History of more than mild obstructive sleep apnea that is untreated

5. Known history of portal hypertension or chronic liver disease, including hepatitis B
and/or hepatitis C (with evidence of recent infection and/or active virus
replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)

6. History of human immunodeficiency virus infection-associated PAH

7. Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536)

8. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
(BP) > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg during Screening
Visit after a period of rest

9. Systolic BP < 90 mmHg during Screening or at baseline

10. History of known pericardial constriction

11. Personal or family history of long QTc syndrome or sudden cardiac death

12. History of restrictive or congestive cardiomyopathy

13. Left ventricular ejection fraction (LVEF) < 45% on historical echocardiogram (ECHO)
within 6 months prior to Screening Period (or done as a part of the Screening Period)
or pulmonary capillary wedge pressure (PCWP) > 15 mmHg as determined in the Screening
Period RHC.

14. 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)

15. Acutely decompensated heart failure within 30 days prior to study visit C1D1, as per
investigator assessment

16. Significant (≥ 2+ regurgitation) mitral regurgitation (MR) or aortic regurgitation
(AR) valvular disease
We found this trial at
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sites
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Namita Sood, MD
Phone: 713-704-6604
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Vallerie McLaughlin, MD
Phone: 734-763-7390
University of Michigan The University of Michigan was founded in 1817 as one of the...
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: David Badesch, MD
Phone: 720-848-6552
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Cincinnati, Ohio 45219
Principal Investigator: Peter Engel, MD
Phone: 513-585-1777
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Darlinghurst, New South Wales 2010
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Gainesville, Florida 32610
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Zeenat Safdar, MD
Phone: 713-796-1701
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Leslie Spikes, MD
Phone: 913-558-4030
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Marietta, Georgia 30106
Principal Investigator: Jeffrey Michaelson, MD
Phone: 470-793-4057
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Phoenix, Arizona 85006
Principal Investigator: David Baratz, MD
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Phoenix, Arizona 85013
Principal Investigator: Jeremy Feldman, MD
Phone: 602-271-0832
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9427 Southwest Barnes Road
Portland, Oregon 97225
Principal Investigator: Jeffrey Robinson, MD
Phone: 503-935-8818
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Franz Rischard, DO
Phone: 520-626-8305
University of Arizona The University of Arizona is a premier, public research university. Established in...
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