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NCT07318597PHASE2Recruiting

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)

Regeneron Pharmaceuticals

Start Date

5/6/2026

Completion Date

9/17/2028

Summary

This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines. The study is looking at several other research questions, including: * What side effects may happen from taking REGN13335 * How much REGN13335 is in the blood at different times * Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could lead to side effects)

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

REGN13335

DRUG

Placebo

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Conditions

Pulmonary Arterial Hypertension (PAH)

Locations

University of Colorado Denver

Aurora, Colorado 80045

United States

Mater Misericordiae Ltd

South Brisbane, Queensland 4101

Australia

Royal Hobart Hospital

Hobart, Tasmania 7000

Australia

UZ Leuven

Leuven, Vlaams-Brabant 3000

Belgium

H.U.B. Erasme Hospital

Brussels, 1070

Belgium

Hopital Bicetre

Le Kremlin-Bicêtre, 94275

France

Universitatsklinikum Halle

Halle, Saxony-Anhalt 06120

Germany

Clinic of University Greifswald

Greifswald, 17485

Germany

Universitatsmedizin Mainz

Mainz, 55131

Germany

P. Stradins Clinical University hospital

Riga, LV1002

Latvia

University Clinical Hospital in Poznan - Early Phase Unit

Poznan, Greater Poland Voivodeship 61-848

Poland

University Hospital in Bialystok

Bialystok, Podlaskie Voivodeship 15-276

Poland

Oddzial Kardiologiczny

Lodz, Łódź Voivodeship 93487

Poland

Gachon University Gil Medical Center

Namdong-gu, Incheon 21565

South Korea

Asan Medical Center

Seoul, Songpa-gu 05505

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hospital Vall d'Hebron

Barcelona, Catalonia 08035

Spain

Hospital Universitario Costa del Sol

Marbella, Malaga 29603

Spain

Hospital Clinic, Barcelona

Barcelona, 08036

Spain

University hospital 12 de octubre

Madrid, 28041

Spain

Royal United Hospitals Bath NHS Foundation Trust

Bath, BA1 3NG

United Kingdom

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, W12 0HS

United Kingdom