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Sotatercept for Pulmonary Arterial Hypertension (LIGHTRAY Trial)

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (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

Has symptomatic PAH classified as WHO Functional Class II or III

Must not have

Has known malignancy that is progressing or has required active treatment within the past 5 years

Has a history of known pericardial constriction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 37 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at a new way to treat people with a condition called PAH, where the blood vessels in the lungs become thick and narrow. They want to see how different doses of a drug

Who is the study for?

This trial is for people with Pulmonary Arterial Hypertension (PAH) who have had a specific heart catheterization test. It's open to those with various PAH types, including idiopathic, heritable, drug-induced or associated with other conditions. Participants should be experiencing symptoms and classified as WHO Functional Class II or III.

What is being tested?

The study tests different doses of Sotatercept in patients with PAH. Researchers want to see how the body reacts over time to weight-banded versus weight-based dosing methods and assess the safety and tolerability of this medication when taken alongside standard PAH therapies.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions at the injection site, issues related to blood flow changes due to vessel alterations caused by Sotatercept, and interactions with existing PAH medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of high blood pressure in the lungs.

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I have PAH and experience mild to moderate symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a cancer that has gotten worse or needed treatment in the last 5 years.

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I have a history of tightness around my heart.

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I weigh less than 35 kg.

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I have been diagnosed with a certain type of pulmonary hypertension.

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I have a specific type of high blood pressure in the lungs related to HIV, liver disease, schistosomiasis, or rare lung conditions.

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I have been diagnosed with restrictive cardiomyopathy.

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I have severe leakage in my heart's mitral or aortic valve.

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I have sleep apnea that hasn't been treated beyond mild.

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My high blood pressure is not under control.

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I have had a lung removed.

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I or someone in my family has long QT syndrome.

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I started or plan to start a weight loss program or medication within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 37 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 37 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 37 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Experience One or More Adverse Events (AEs)

Number of Participants who Discontinue Study Treatment due to an Adverse Event

Steady-State Average Serum Concentrations of Sotatercept (Cavg)

Secondary study objectives

Initial Dose Average Serum Concentrations of Sotatercept (Cavg)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Weight-based sotatercept dosingExperimental Treatment2 Interventions

Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.

Group II: Weight-banded sotatercept dosingExperimental Treatment2 Interventions

Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sotatercept

2019

Completed Phase 3

~690

Background PAH Therapy

2021

Completed Phase 3

~330