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New PET scans reveal how experimental drug reshapes lung vessels in PAH

NCT ID NCT07357974

Knowledge-focused Sponsor: University Hospital, Brest Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study will use special PET/CT scans to see how the experimental drug sotatercept affects blood vessel remodeling in the lungs and heart of people with pulmonary arterial hypertension (PAH). About 15 adults with PAH will receive sotatercept and have imaging at the start and after 24 weeks. The goal is to measure changes in fibroblast activity and lung blood flow, not to treat symptoms directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * 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/toxine-induced PAH * PAH associated with connective tissue disease * PAH associated with simple, congenital systemic-to- pulmonary shunts at least 1year following repair * Patients under bi or tri-background-therapy * Symptomatic PAH classified WHO FC II or III * Patients will be started on Sotatercept * Ability to adhere to study visit schedule and understand and comply with all the protocol requirement. * Ability to understand and provide written informed consent Exclusion Criteria: * Diagnosis of PH WHO Groups 2, 3, 4, or 5 * Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis. * Hemoglobin at screening above gender-specific ULN, per local laboratory test * Pregnant or breastfeeding women * Any of the following clinical laboratory values at the Screening visit: * eGFR \< 30 mL/min/1.73 m2 (as defined by MDRD equation) * Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels \> 3 × ULN * Platelet count \< 50,000/mm3 (\< 50.0 × 109/L) * Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension (PAH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chu Brest

    Brest, Finistere, 29200, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.