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New antibody drug aims to ease lung blood pressure

NCT ID NCT07318597

Disease control Sponsor: Regeneron Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 16, 2026 · Updated 10 times

Summary

This study tests an experimental drug called REGN13335 in 99 adults with pulmonary arterial hypertension (PAH), a condition where high blood pressure in the lungs makes the heart work harder. Participants will receive either the drug or a placebo, on top of their usual PAH medications. The goal is to see if REGN13335 safely lowers lung blood pressure and improves heart function.

What this could mean

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

Active substance
REGN13335 (an antibody that blocks a protein called PDGF-B)
What this could lead to
If it works, this could lead to a new treatment option for people with pulmonary arterial hypertension, helping to lower blood pressure in the lungs and improve heart function.
What could go wrong
This is a mid-stage trial with only 99 participants, so results may not apply to everyone. The drug is still experimental, and 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 99 people

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

Started

May 2026

Expected to finish

Sep 2028

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

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.

Key Inclusion Criteria: 1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH)) 2. WHO functional class II or III (slight to marked limitation of functional status due to PAH) 3. Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the protocol 4. PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period 5. Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol Key Exclusion Criteria: 1. Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and/or hypoxia), Group 4 (PH associated with pulmonary artery obstructions), or Group 5 (PH with unclear and/or multifactorial mechanisms) PH according to the 7th WSPH 2. Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period 3. History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol 4. Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity \<0.7 and FEV1 \<70% of the predicted value as described in the protocol 5. Evidence of interstitial lung disease as defined in the protocol 6. Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol 7. Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol 8. Has any history of intracranial bleeding or any history of elevated intracranial pressure 9. Has any history of bleeding meeting criteria as described in the protocol Note: Other protocol-defined Inclusion/ Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension pulmonary 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

    30 sites in 10 countries. 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

  • Asan Medical Center

    RECRUITING

    Seoul, Songpa-gu, 05505, South Korea

  • Clinic of University Greifswald

    RECRUITING

    Greifswald, 17485, Germany

  • Gachon University Gil Medical Center

    RECRUITING

    Namdong-gu, Incheon, 21565, South Korea

  • H.U.B. Erasme Hospital

    RECRUITING

    Brussels, 1070, Belgium

  • Hopital Bicetre

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • Hospital Clinic, Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Universitario Costa del Sol

    RECRUITING

    Marbella, Malaga, 29603, Spain

  • Hospital Universitario De Toledo

    RECRUITING

    Toledo, 45007, Spain

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Imperial College Healthcare NHS Trust, Hammersmith Hospital

    RECRUITING

    London, W12 0HS, United Kingdom

  • Mater Misericordiae Ltd

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Nouvel hopital civil

    RECRUITING

    Strasbourg, 67091, France

  • Oddzial Kardiologiczny

    RECRUITING

    Lodz, Łódź Voivodeship, 93487, Poland

  • P. Stradins Clinical University hospital

    RECRUITING

    Riga, LV1002, Latvia

  • Royal Hobart Hospital

    RECRUITING

    Hobart, Tasmania, 7000, Australia

  • Royal United Hospitals Bath NHS Foundation Trust

    RECRUITING

    Bath, BA1 3NG, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UZ Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Universitatsklinikum Halle

    RECRUITING

    Halle, Saxony-Anhalt, 06120, Germany

  • Universitatsmedizin Mainz

    RECRUITING

    Mainz, 55131, Germany

  • University Clinical Hospital in Poznan - Early Phase Unit

    RECRUITING

    Poznan, Greater Poland Voivodeship, 61-848, Poland

  • University Hospital Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • University Hospital in Bialystok

    RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

  • University hospital 12 de octubre

    RECRUITING

    Madrid, 28041, Spain

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Colorado Denver

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Nebraska Medical Center - 2365

    RECRUITING

    Omaha, Nebraska, 68198, United States

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