Recruiting
Phase 2

REGN13335

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07318597

Conditions

Pulmonary Arterial Hypertension (PAH)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN13335

Placebo

Study Details

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)

Study ID

NCT07318597

Start date

May 6, 2026

Status verified date

Aug, 2026

Completion date

Sep 17, 2028

Anticipated

Primary completion date

Feb 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

99 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DBTP-Arm1

experimental: DBTP-Arm2

placebo comparator: DBTP-Arm3

experimental: OLE-Arm1

experimental: OLE-Arm2

Interventions

REGN13335

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Change from baseline in Pulmonary Vascular Resistance (PVR) [ Time Frame: At week 24 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-19.