Sotatercept for Pulmonary Arterial Hypertension

(LIGHTRAY Trial)

Not currently recruiting at 124 trial locations
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Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called sotatercept for individuals with pulmonary arterial hypertension (PAH). PAH causes the blood vessels in the lungs to thicken and narrow, hindering blood flow. The study will compare two dosing methods of sotatercept to determine which is more effective and safer. Individuals with PAH who experience symptoms like reduced exercise capacity or shortness of breath may be suitable for this trial. Participants will continue their current PAH treatments while receiving sotatercept injections every three weeks. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sotatercept is generally well-tolerated by people with pulmonary arterial hypertension (PAH). In earlier studies, adding sotatercept to other PAH treatments improved exercise capacity and reduced the likelihood of symptom worsening. Long-term studies indicate that the benefits of sotatercept outweigh the downsides.

Safety data from past research shows that researchers have carefully monitored sotatercept, and a safety committee has reviewed the results to ensure its safety. While no treatment is completely free of side effects, testing suggests that sotatercept is safe for most people when added to existing PAH treatments. Prospective participants should always consult a doctor about what to expect when considering joining a trial.12345

Why are researchers excited about this trial's treatment for PAH?

Researchers are excited about sotatercept for pulmonary arterial hypertension (PAH) because it introduces a novel approach by targeting the transforming growth factor-beta (TGF-β) superfamily, which is different from the standard therapies like endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclins. Most current treatments focus on relaxing blood vessels and improving blood flow, but sotatercept works by potentially reducing the excessive proliferation of blood vessel cells, addressing a root cause of the disease. Additionally, sotatercept is administered via subcutaneous injection every three weeks, which could offer a more convenient dosing schedule compared to some existing treatments. These unique features have sparked interest in its potential to offer improved outcomes for PAH patients.

What evidence suggests that sotatercept might be an effective treatment for pulmonary arterial hypertension?

Studies have shown that sotatercept can help treat pulmonary arterial hypertension (PAH) by improving exercise capacity and reducing the likelihood of symptom worsening. In this trial, participants will receive sotatercept using one of two dosing methods: weight-based or weight-banded, alongside their regular PAH medications. Earlier trials demonstrated that patients who took sotatercept with their regular PAH medications experienced overall improvement. The drug aids the blood vessels in the lungs, which can become thick and narrow in PAH, allowing blood to flow more easily. Early and ongoing research indicates that sotatercept offers a good balance of benefits and risks for people with PAH.12345

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have PAH and experience mild to moderate symptoms.
I have been diagnosed with a specific type of high blood pressure in the lungs.

Exclusion Criteria

I had a heart procedure called atrial septostomy within the last 6 months.
My high blood pressure is not under control.
I weigh less than 35 kg.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sotatercept via subcutaneous injection every 3 weeks using either a weight-based or weight-banded method during a 24-week treatment period

24 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sotatercept
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Weight-based sotatercept dosingExperimental Treatment2 Interventions
Group II: Weight-banded sotatercept dosingExperimental Treatment2 Interventions

Sotatercept is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Winrevair for:
🇺🇸
Approved in United States as Winrevair for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

The Phase 3 STELLAR trial demonstrated that sotatercept significantly improves exercise capacity and reduces pulmonary vascular resistance in patients with pulmonary arterial hypertension, indicating its efficacy as a treatment option.
The study involved a large cohort of patients, providing robust evidence for the safety and effectiveness of sotatercept in managing this serious condition.
In symptomatic PAH, adding sotatercept to stable background therapy improved 6-min walk distance at 24 wk.Estrada, RA.[2023]
In a phase 3 trial involving 323 adults with pulmonary arterial hypertension, sotatercept significantly improved exercise capacity, as measured by a 34.4 m increase in the 6-minute walk distance compared to just 1.0 m in the placebo group, indicating its efficacy in enhancing physical performance.
Sotatercept also showed significant improvements across multiple secondary endpoints related to pulmonary health, although it was associated with some adverse effects like epistaxis and increased blood pressure, highlighting the need for monitoring during treatment.
Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension.Hoeper, MM., Badesch, DB., Ghofrani, HA., et al.[2023]
In a study involving 106 participants with pulmonary arterial hypertension, sotatercept demonstrated significant long-term efficacy in reducing pulmonary vascular resistance and improving functional outcomes over 24 months, with sustained benefits observed in both groups receiving sotatercept.
The treatment was generally safe, with serious adverse events occurring in 30.8% of participants, but only a small number (2.9%) of deaths were reported, none linked to the drug, indicating a favorable safety profile for long-term use.
Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension.Humbert, M., McLaughlin, V., Gibbs, JSR., et al.[2023]

Citations

U.S. FDA Approves Updated Indication for WINREVAIR ...Adding WINREVAIR to background PAH therapy improved exercise capacity and WHO functional class (FC), and reduced the risk of clinical ...
Phase 3 Trial of Sotatercept for Treatment of Pulmonary ...An independent data and safety monitoring committee reviewed unblinded safety data collected 21 days after administration of the first dose of sotatercept or ...
Clinical Trial Results for WINREVAIR™ (sotatercept-csrk)WINREVAIR™ (sotatercept-csrk) was studied in the 6-month STELLAR clinical study. Patients can view clinical trial results for WINREVAIR.
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39978862/
A long-term follow-up study of sotatercept for treatment ...Interim results of SOTERIA support the favourable benefit-risk of add-on sotatercept treatment in adults with PAH. Follow-up reports from ...
Study Details | NCT04796337 | A Long ...This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants ...
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