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NCT Number: NCT07318597

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

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)

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mater Misericordiae Ltd, South Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Treatment and study plan

REGN13335

Drug

Administered per the protocol

Placebo

Drug

Administered per the protocol

Primary outcomes

  1. Change from baseline in Pulmonary Vascular Resistance (PVR)

    Time frame: At week 24

Secondary outcomes

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Through end of study, up to approximately 2.5 years

  2. Severity of TEAEs

    Time frame: Through end of study, up to approximately 2.5 years

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

    Time frame: At week 24

  4. Change from baseline in mean pulmonary artery pressure

    Time frame: At week 24

  5. Change from baseline in cardiac output

    Time frame: At week 24

  6. Change from baseline in cardiac index

    Time frame: At week 24

  7. Change from baseline in right atrial pressure

    Time frame: At week 24

  8. Change from baseline in 6-Minute Walk Distance (6MWD)

    Time frame: At week 24

  9. Concentrations of functional REGN13335 in plasma

    Time frame: Through end of study, up to approximately 2.5 years

  10. Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma

    Time frame: Through end of study, up to approximately 2.5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension

Acronym: ILLUMINATE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 6, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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