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New drug hopes to ease rare lung condition in children

NCT ID NCT07646860

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 4 times

Summary

This study tests the safety and tolerability of sotatercept in Japanese children aged 1 to 18 with pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs narrow, making the heart work harder. Participants receive sotatercept injections every three weeks alongside their usual PAH medications. Researchers monitor side effects, how the drug moves through the body, and whether it helps lower resistance in lung blood vessels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sotatercept
What this could lead to
If successful, this could provide a new treatment option for children with pulmonary arterial hypertension, potentially improving blood flow and easing strain on the heart.
What could go wrong
This is a small, early-phase study with only 6 participants, so results may not apply to all children. Side effects or lack of benefit are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 6 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 year to 17 years

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: The main inclusion criteria include but are not limited to the following: * Has pulmonary arterial hypertension (PAH, World Health Organization Group 1) confirmed by a prior right heart catheterization * Has idiopathic, heritable, drug- or toxin-induced PAH, connective tissue disease-associated PAH, repaired congenital heart disease-associated PAH, or PAH with coincidental shunt * Has PAH classified as World Health Organization Functional Class I, or symptomatic World Health Organization Functional Class II to IV * Has been receiving stable standard-of-care background therapy for PAH for at least 90 days * Is Japanese Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * History of left-sided heart disease * Has severe congenital or developmental abnormalities of the lung, thorax, and/or diaphragm * History of Eisenmenger syndrome, Potts shunt, or recent atrial septostomy within 180 days * Has unrepaired or residual cardiac shunt with Qp/Qs \>1.5 * Has pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or overt signs of pulmonary capillary and/or venous involvement * PAH associated with portal hypertension * Known visceral arteriovenous malformations * History of full or partial pneumonectomy * Untreated more than mild obstructive sleep apnea * History of known pericardial constriction * Family history of sudden cardiac death or long QT syndrome * History of symptomatic coronary disease within 6 months or cerebrovascular accident within 3 months * Prior treatment with sotatercept 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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • National Center for Child Health and Development ( Site 3202)

    RECRUITING

    Setagaya City, Tokyo, 157-8535, Japan

  • Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203)

    RECRUITING

    Izumi, Osaka, 594-1101, Japan

  • The University of Osaka Hospital ( Site 3201)

    RECRUITING

    Suita, Osaka, 565-0871, Japan

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