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

NCT07318597 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: R13335-PAH-23652024-514754-79-00
• Study Type: interventional
• Target: 99
• Locations: 3 countries
• Sites: 3

Brief 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)

Conditions

Pulmonary Arterial Hypertension (PAH)

Keywords

Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension (PH); Elevated Pulmonary Vascular Resistance (PVR); World Health Organization (WHO) functional class II or III; Platelet-Derived Growth Factor-B (PDGF-B); REGN13335

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Pulmonary Vascular Resistance (PVR)

  At week 24

Secondary Outcomes (10)

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Through end of study, up to approximately 2.5 years

• Severity of TEAEs

  Through end of study, up to approximately 2.5 years

• Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations

  At week 24

• Change from baseline in mean pulmonary artery pressure

  At week 24

• Change from baseline in cardiac output

  At week 24

Study Arms (5)

DBTP-Arm1

EXPERIMENTAL

Drug: REGN13335

DBTP-Arm2

EXPERIMENTAL

Drug: REGN13335

DBTP-Arm3

PLACEBO COMPARATOR

Drug: Placebo

OLE-Arm1

EXPERIMENTAL

Drug: REGN13335

OLE-Arm2

EXPERIMENTAL

Drug: REGN13335

Interventions

REGN13335 DRUG

Administered per the protocol

DBTP-Arm1; DBTP-Arm2; OLE-Arm1; OLE-Arm2

Placebo DRUG

Administered per the protocol

DBTP-Arm3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))
• WHO functional class II or III (slight to marked limitation of functional status due to PAH)
• 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
• PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period
• Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol

You may not qualify if:

• 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
• Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period
• History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol
• 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
• Evidence of interstitial lung disease as defined in the protocol
• Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol
• Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol
• Has any history of intracranial bleeding or any history of elevated intracranial pressure
• Has any history of bleeding meeting criteria as described in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (3)

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will include: A Double-Blind Treatment Period (DBTP) and an Open-Label Extension (OLE) period for participants who choose to continue treatment

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 6, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): March 8, 2028
• Study Completion (Estimated): September 27, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

GB (1); US (1); KR (1)