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Growth Factor

Sotatercept for Pulmonary Arterial Hypertension

Phase 4
Recruiting
Led By Yogesh Reddy, MBBS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP <25 mm Hg)
Be older than 18 years old
Must not have
Planned coronary, carotid, or peripheral artery revascularization
Wheelchair bound or orthopedic inability to exercise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether a drug called sotatercept can improve heart function and quality of life when taken for 36 weeks.

Who is the study for?
This trial is for individuals with Pulmonary Arterial Hypertension (PAH), a type of high blood pressure affecting the arteries in the lungs and heart. Participants should have PAH diagnosis and meet specific health criteria not detailed here.
What is being tested?
The study tests if sotatercept, administered over 36 weeks, can enhance heart function and quality of life in PAH patients. It's an investigation into the drug's long-term effects on cardiopulmonary performance during exercise.
What are the potential side effects?
While specific side effects are not listed, drugs like sotatercept could potentially cause issues such as headache, nausea, dizziness, or reactions at the injection site. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have high blood pressure in the lungs without heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a procedure to improve blood flow to my heart, neck, or limbs.
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I am unable to exercise due to being in a wheelchair or having a bone/joint problem.
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I am not pregnant, breastfeeding, planning to become pregnant, or if I can have children, I am using effective birth control.
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I have had rhabdomyolysis in the past.
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I need extra oxygen to exercise due to chronic low oxygen levels.
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I have a muscle disease.
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I am not scheduled for major surgery that will affect my walking during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise
Secondary study objectives
Change in skeletal muscle O2 diffusive conductance (Dm) during peak exercise
Change in skeletal muscle O2 diffusive conductance (Dm) during single leg exercise
Eccentricity index at peak exercise
+15 more

Side effects data

From 2022 Phase 3 trial • 324 Patients • NCT04576988
20%
Headache
15%
COVID-19
12%
Diarrhoea
12%
Epistaxis
10%
Telangiectasia
10%
Nausea
10%
Fatigue
10%
Dizziness
7%
Injection site pain
6%
Hypokalaemia
6%
Rash
6%
Flushing
5%
Oedema peripheral
5%
Thrombocytopenia
4%
Nasopharyngitis
3%
Urinary tract infection
2%
Dyspnoea
1%
Iron deficiency
1%
Fall
1%
Bronchitis
1%
Pulmonary arterial hypertension
1%
Inguinal hernia
1%
Atrial flutter
1%
Supraventricular tachycardia
1%
Abdominal pain
1%
Pancreatitis
1%
Cellulitis
1%
Pneumonia
1%
Pneumonia influenzal
1%
Respiratory tract infection
1%
Sepsis
1%
Upper respiratory tract infection
1%
Osteoporotic fracture
1%
Acute kidney injury
1%
Haemoptysis
1%
Pulmonary artery aneurysm
1%
Upper gastrointestinal haemorrhage
1%
Joint injury
1%
Sjogren's syndrome
1%
Cerebral haematoma
1%
Device malfunction
1%
Nephritis
1%
Sarcoidosis
1%
Gastroenteritis viral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus Background PAH Therapy (LTDB Period)
Placebo Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (DBPC Period)
Sotatercept Plus Background PAH Therapy (LTDB Period)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sotatercept TherapyExperimental Treatment1 Intervention
All participants will receive 36 weeks of sotatercept therapy. Sotatercept is administered as a subcutaneous injection once every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotatercept
2019
Completed Phase 3
~690

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,328 Total Patients Enrolled
14 Trials studying Pulmonary Arterial Hypertension
1,708 Patients Enrolled for Pulmonary Arterial Hypertension
Yogesh Reddy, MBBSPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
4 Total Patients Enrolled
~7 spots leftby Feb 2025
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